Patient Safety: The Reuse of Single Use Devices · The filter precludes any infective or hazardous particles entering the patient’s respiratory tract from the anaesthetic gases.

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Patient Safety: The Reuse of Single Use Devices

Institute for Science and Society

University of Nottingham

University Park

Nottingham

NG7 2RD

Tel: +44 (0)115 846 8144

Fax: +44 (0)115 846 6349

Web: www.nottingham.ac.uk/igbis/singleuse

Email: [email protected]

[email protected]

Competing interests: none

Word count: 33,319

February 2007

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Abbreviations

AAGBI Association of Anaesthetists of Great Britain and Ireland

AfPP Association for Perioperative Practice (previously NATN)

AODP Association of Operating Department Practitioners

ASGBI Association of Surgeons of Great Britain and Ireland

BAREMA Trade Association for Anaesthetic and Respiratory Equipment

CDA Clinical Director of Anaesthesia

CJD Creutzfeld Jakob Disease

COREC Central Office for Research Ethics Committee

CRB Criminal Records Bureau

CSD Central Sterilisation Department

DNA Do Not Attend

DVT Deep Vein Thrombosis

EGBAT Expert Group on Blocked Anaesthetic Tubng

EU CEN European Union’s European Standardisation Committee

FT Full Time

HIV Human Immunodeficiency Virus

HR Human Resources

IV Intra Venous

LMA Laryngeal Mask Airway

LOS Length of Stay

LREC Local Research Ethics Committee

MCA Medicines Control Agency

MDA Medical Device Agency

MDD Medical Devices Directive

MHRA Medicine and Healthcare products Regulatory Agency

MHRA CSD MHRA’s Committee for the Safety of Medical Devices

MREC Multi-centre Research Ethics Committee

NATN National Association of Theatre Nurses (now AfPP)

NHS National Health Service

NHS PASA National Health Service Logistics, Purchasing and Supply Agency

NICE National Institute for Clinical Effectiveness

NPSA National Patient Safety Agency

NSF National Service Framework

ODP Operating Department Practitioner

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OEM Original Equipment Manufacturer

OTJ Operating Theatre Journal

PCA Patient Controlled Analgesia

R&D Research and Development

RCOA Royal College of Anaesthetists

RGF Research Governance Framework

SABS Safety Alert Broadcast System

SEAC Spongiform Encephalopathy Advisory Committee

SHA Strategic Health Authority

SM Sterilisation Manager

SPSS Statistical Package for the Social Sciences

SUD Single Use Devices

TM Theatre Manager

TSEs Transmissible Spongiform Encephalopathies

vCJD Variant Creutzfeld Jakob Disease

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Glossary

Ablation catheter Long, thin tube (catheter) is threaded into the heart to

destroy (ablate) an area of heart tissue that is causing

abnormal heart rhythms. Given the thin nature of tube,

decontamination is considered ineffective, due to

difficulties in establishing that all parts of the device are

‘clean’ and contaminant free.

Adenoidectomy Operation to remove swollen adenoids, tissue lying

between the throat and the noise.

‘Ambu’ bag Manual resuscitation bag; Ambu (manufacturer). Other

products are available.

Anaesthetic breathing

system

(also referred to as

circuit / ventilator)

Forms part of the anaesthetic system. Device delivers

gases to ventilate the anaesthetised patient. Made of

corrugated plastic tubing.

Anglepieces Part of the anaesthetic breathing system.

Biopsy forcep Instrument with metal jaw which can be used to remove

biopsies (samples) from tissue.

Breathing filter Used in conjunction with an anaesthetic breathing system.

The filter precludes any infective or hazardous particles

entering the patient’s respiratory tract from the anaesthetic

gases. A new breathing filter must be used with each

patient.

Burr Surgical instrument used to drill holes in bones.

Capnograph lines Used to measure CO2 levels during anaesthesia.

Cardiac catheter Similar to ablation catheter; long thin tube (catheter) is

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threaded though body (usually from an incision in the

groin) to the heart, and is used to obtain diagnostic

information regarding heart disease.

Catheter mounts Transparent tubing, connecting the patient to the breathing

circuit.

CJD / vCJD Creutzfeld-Jakob Disease / variant Creutzfeld-Jakob

Disease – a rare and fatal neurodegenerative disease;

linked to presence of prion protein, which is found

principally in the brain, spinal cord and lympatic tissue

such as the spleen, appendix and tonsils.

CO2 adaptors Component of the breathing system.

Compression

(anti DVT) garment

Non-invasive, intermittent pneumatic compression devices.

Used to boost circulation and thus prevent episodes of

deep vein thrombosis following immobility. Examples

include ‘Flowtron boots’.

Cornea The front of the eye; transparent.

Decontamination

process

Eliminates or reduces the level of microbes and other

unwanted material from devices, which may otherwise

cause infection or colonisation. Achieved through a

combination of cleaning, disinfecting and sterilising, using

chemical agents and steam autoclaves.

Diphtheroids Type of bacteria.

Doppler probe Used to monitor venous flow.

Electrophysiological

catheter

Used to examine cardiac output and gather electrical

tracings and measurement of the heart.

Elephant tubing Part of the anaesthetic breathing system, connecting

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patient to the anaesthetic machine. Made from plastic.

Endoscopic Type of surgical procedure, in which the surgeon operates

in the body cavity through small incisions. Also see

laparoscopic.

Endoscopic

biopsy forceps

Device used to remove tissue samples. Used in

conjunction with an endoscope (an instrument which is

used to examine the internal body via a small incision).

Endotoxins Toxins linked to bacteria, which result in fevers and altered

resistance to bacterial infections.

Endotrachael tube Tube placed in the patient’s mouth or nose, which assists

with breathing when ventilated.

Enteral system Method of delivering a substance to gastrointestinal

system.

Facemask Used to administer anaesthetic gases and/or oxygen to

patients.

‘Flowtron’ boots Anti DVT garments.

Gas sampling line Thin plastic tube attached to anaesthetic breathing system.

Allows anaesthetist to monitor gases given to and used by

patient.

Green bubble tubing Tubing used to deliver oxygen therapy. Made from plastic.

Gum elastic bougies

(Bougies / Intubating

stylets)

Rubber or plastic device, shaped like a thin cylinder and

malleable; inserted into oesophagus to guide another

instrument (such as LMA or other breathing assistance

device) into place.

Hepatitis B A virus that attacks the liver and causes it to become

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inflamed; long term infection can lead to liver disease,

death from liver cancer or cirrhosis.

Hepatitis C A virus resulting in serious damage of the liver and affects

its ability to function correctly. Also found in digestive

system, the lymphatic system, the immune system and the

brain. It is mainly spread through contact with the blood of

a person who is infected.

Hypoxia Deficiency of oxygen.

Iatrogenic Medically induced harm.

Invasive / Non invasive

devices

Classification of medical devices, as defined by MHRA and

Medical Device Directive. Generally speaking, devices are

classified according to whether they enter bodily orifices or

the surgical site (invasive), or whether they come into

contact with injured skin or are used to collect blood and

other liquids (non-invasive).

Laparoscopic Refers to surgery carried out through small incisions in

body, during which instruments are passed down a small

tube.

Laryngoscope Device used by anaesthetist to obtain a view of the glottis

(narrow opening in the trachea airway) whilst performing

intubation. It consists of a metal handle and blade, which

can be either plastic or metal. Available as both single use

and reprocessable. Concern lies with 1) impatternation of

handle and potential for blood/tissue to become ingrained

in the markings, and subsequently come into contact with

the blade, and 2) likely presence of blood/tissue on the

blade.

Larynx Area of the throat containing vocal chords.

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Laryngeal Mask Airway

(LMA)

Airway device used to ventilate patient during anaesthesia.

Inserted into patient’s larynx.

Lumen A hollow area within a tube / device.

Lymphatic tissue Refers to cells containing and carrying blood throughout

the body.

Macintosh

laryngoscope

Type of laryngoscope blade.

Magill forceps

Metal forceps used to assist with the removal of

objects/foreign bodies.

Mapleson C Circuit Type of anaesthetic breathing system.

McCoy laryngoscope Type of laryngoscope blade.

Mucous membranes Moist tissue lining the interior bodily cavity.

Nephrectomy Removal of the kidney.

Nosocomial Infection originating in a hospital.

Oesophagus

/ Oesophagectomy

Piece of the gullet running from the throat to the intestines;

operation to remove oesophagus.

Oxygen bags Rubber inflatable bags used to deliver oxygen to patient.

Pacing electrode Used to observe cardiac output.

Pressure (infuser) bag Inflatable bag (bladder) used to assist with the

administration of intra-venous fluids to patient.

Prion / Prion disease Infectious agent derived from protein. Linked to

transmissible spongiform encephalopathy, such as CJD.

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Probes Device used to explore body cavity such as brain.

Proteinaceous Describes presence of protein, prions or other material

linked to disease causation.

Recovery T pieces

Part of the anaesthetic breathing system, connecting

patient to oxygen delivery system.

Saw blades Orthopaedic surgical tool.

Sclerosing needle Instrument used to deliver solution; used to treat varicose

veins.

Snare Instrument with a closable wire loop. Often used to take

samples.

Spirometry tubing Used to monitor patient’s breathing whilst under

anaesthesia.

Splencectomy Removal of the spleen.

Subcutaneous Under the skin.

Trocar Instrument placed into the body, through which other,

endoscopic and laparoscopic instruments can be placed.

TSE Transmissible Spongiform Encephalopathy; linked to

prions.

Vascular Relating to the blood vessels.

Ventilator tubing Used with anaesthetic breathing system. Made from

plastic.

.

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Contents

Abbreviations 2-3

Glossary 4-9

Contents 10

List of tables and figures 11-12

Executive summary 13-17

Introduction 18

Part 1: The Inventory 19-21

Part 2: The Survey 22-55

Part 3: The Interviews 56-111

Conclusion and Recommendations 112-117

Acknowledgements 118-119

References 120-130

Appendix 1: Inventory of reused single use devices 131-192

Appendix 2: Survey Methodology

Appendix 3: Ineligible survey data

Appendix 4: Interview Methodological Details

Appendix 5: R&D log

193-197

198-201

202-206

207-210

Appendix 6: Ergonomics of single use devices, incl. recommendations 211-225

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List of figures and tables

Table 1 The most frequently reported single use devices reused

(Inventory)

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Table 2 Occupational characteristics of sample (Survey) 25

Table 3 Single use definitions (Survey) 27

Table 4 Reused single use devices (Survey) 30

Table 5 Reuse of facemasks (Survey) 36

Table 6 Rationales for reuse of single use devices (Survey) 41

Table 7 Number of operations performed per annum / cost (Survey) 43

Table 8 Proposed cost savings linked to reuse of single use devices 43

Table 9 Number of operations performed per annum / waste

(Survey)

45

Table 10 Number of operations performed per annum / number of

beds / reuse (Survey)

47

Table 11 Reuse of single use devices in other hospitals (Survey) 48

Table 12 Comparing reuse of single use devices in own and other

hospitals (Survey)

48

Table 13 Perceived dangers and risks associated with the reuse of

single use devices (Survey)

49

Table 14 Awareness and understanding of guidance relating to the

use of single use devices (Survey)

53

Table 15 Awareness of Trust policy on the use of single use devices

(Survey)

54

Table 16 Trusts participating in the survey recruited for interview

phase (Interview)

56

Table 17 Reuse of single use devices reported by survey participants

recruited for interview phase (Interview)

56

Table 18 Overview of additional Trusts recruited for interview phase

(Interview)

57

Table 19 Sample composition (Interviews) 58

Table 20 Popular definitions of single use (Interview) 72

Table 21 Reused single use reported by participants (Interview) 81

Table 22 Benefits / impact of service change model (Interview) 84

Table 23 Ineligible data: sample characteristics (Appendix 1) 198

Table 24 Ineligible data: definitions of single use (Appendix 1) 199

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Table 25 Ineligible data: reported reuse (Appendix 1) 200

Table 26 Ergonomic report: detailed description of labelling

(Appendix 6)

216-

219

Figure 1 Geographical characteristics of sample (Survey) 26

Figure 2 Positioning of the laryngoscope 38

Figure 3 Location of the tonsils 39

Figure 4 Positioning of the laryngeal mask 66

Figure 5 Inconsistent labelling (Interview) 68

Figure 6 Single use logo (Interview) 72

Figure 7 Contaminated, reused single use laryngoscope blade

(Interview)

74

Figure 8 Intavent Orthofix LMA colour coding scheme (Interview) 75

Figure 9 Eschmann bougie: Instructions for cleaning, disinfection and

storage (Interview)

76

Figure 10 Eschmann and Portex bougies (Interview) 77

Figure 11 Sample breathing circuits (Interview) 79

Figure 12 ET connector and IV giving set (Interview) 80

Figure 13 Time-motion image of bougie and its ability to retain its

shape

92

Figure 14 Single use laryngoscope blade (Interview) 96

Figure 15 Reusable laryngoscope handle (Interview) 96

Figure 16 Europa laryngoscope pouch (Appendix 6) 213

Figure 17 Example of multiple use symbol (Appendix 6) 215

Figure 18 Example of single use label using text (Appendix 6) 215

Figure 19 Examples of inconsistency in font style and size in labelling

(Appendix 6)

219

Figure 20 Labelling observed on devices (Appendix 6) 220

Figure 21 Examples of the similarities between the single use icon

and other item labelling (Appendix 6)

220

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Executive Summary

Patient safety has become an increasing concern for the National Health Service

since the publication of An Organisation with a Memory. The National Patient Safety

Agency was created with the express aim of learning from critical incidents (patient

safety incidents), identifying safety risks, and developing methods to prevent such

risks and incidents from re-occurring.

This report examines one identified risk to patient safety: the reuse of ‘single use’

devices. Reuse poses a threat to patient safety in terms of cross infection, including

blood borne diseases such as HIV and Hepatitis B and C, and prion diseases such

as CJD. Patient safety is also threatened by device malfunction and breakage linked

to reuse, for which the devices are not designed.

This report provides an account of a programme of research undertaken over 24

months. This examines data collected via an inventory of published accounts of

reuse, a web-based survey and in-depth interviews with clinical staff working in

theatre and anaesthetic departments in NHS acute hospitals in England.

The inventory of published accounts of reused single use devices revealed a varied

pattern of practice across North America, Europe and Australasia. A total of 477

accounts were found, detailing the reuse of 291 different anaesthetic and surgical

devices. These included: catheters, needles, laparoscopic and endoscopic

instruments, biopsy forceps, breathing filters, airway devices, endotracheal tubes and

laryngeal masks. As expected, reuse was most prevalent in the USA, where

reprocessing of single use devices is regulated by the FDA. However, reuse was also

reported in countries where the practice has been outlawed. For example, single use

anaesthetic devices including breathing filters, laryngoscope blades and laryngeal

masks were reported as being reused in the UK, despite official guidance to the

contrary.

The web-based survey of theatre personnel extended our focus on the reuse of

single use devices in the English NHS. We had intended that the survey data could

be used to estimate the prevalence and incidence of reuse, as well as the categories

of device involved. However, bureaucratic obstacles introduced by the Research

Governance Framework for Health and Social Care and European Clinical Trials

Directive, resulted in a much smaller sample of informants with an unknown

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relationship to the population of hospitals and possible response biases.

Unfortunately, this means that the survey data cannot be extrapolated to calculate

the extent of reuse in the NHS.

Despite its methodological shortcomings, the survey data provides a revealing insight

into the use and reuse of single use devices in a small number of hospitals. The data

demonstrates that clinicians find the definition of ‘single use’ to be confusing, and that

‘single use’ and ‘single patient use’ are understood differently, despite both falling

under the same guidance offered by the Medicines and Healthcare products

Regulatory Agency.

Examples of reuse reported by survey participants included breathing circuits,

facemasks, monitoring and sampling lines, intubating equipment, anti DVT garments

and diathermy equipment. Reuse was rationalised in relation to the prohibitive cost of

replacing each device after just one use, the environmental impact of disposing of the

clinical waste, a perceived lack of risk associated with reuse, and problems with the

supply chain resulting in a lack of other equipment.

The third phase of the research built on the survey findings to gain further

understanding of the context in which decisions relating to the use and reuse of

single use devices are made. 23 in-depth interviews with frontline theatre staff were

carried out in 10 acute NHS hospitals across England. Participants included theatre

managers, operating department practitioners, sterilisation managers and clinical

directors of anaesthesia.

While reuse was only reported by a small proportion of the respondents, the data

allows an understanding of the clinical and financial context in which reuse occurs to

be gained. The factors that lead a clinician to reuse a single use device include the

design and labelling of devices, awareness and understanding of the single use logo,

issues relating to the quality and effectiveness of equipment, contradictory guidance,

and human failings linked to knowledge and situational awareness.

Our survey and interview participants rationalised the reuse of single use devices in

terms of the financial implications of discarding the devices after just one use. Yet

economic analysis of cost data supplied by one participant and the NHS Purchasing

and Supply Agency, demonstrates that, when all associated costs are linked to

reuse, including original purchase price, decontamination, packaging and costs

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incurred as a result of a critical incident, this is unlikely to yield any significant cost

savings. Lastly, we performed an ergonomic analysis of the single use devices which

were most frequently reported as being reused, both by survey and interview

participants. This analysis concluded that reuse may be influenced by the labelling,

packaging and material properties of the devices. In particular, the ergonomic

analysis reiterates our concerns about the single use logo and its familiarity, and

ambiguities regarding whether a device should be used on a single occasion or in the

treatment of a single patient.

The results from this study appear to show that, although not widespread, reuse of

single use devices is still an important issue and of considerable concern. Clinicians

were insistent that the use of single use devices is in the patient’s best interest, and

is best clinical practice. Although some participants voiced concerns about the

effectiveness of some single use devices and the negative environmental impact of

disposing of the devices, tellingly, most would want single use devices used on

themselves or family members if they were ever patients.

We found that there are several physical reasons why single use devices might be

misused, including:

• Misunderstanding of the definition

• Design characteristics

• Suitability and safety of other devices.

• Discrepancies in labelling

The safe delivery of healthcare is also threatened by organisational factors,

including:

• Lack of awareness about single use devices

• Perception that reuse of single use devices is cheaper

• Fragmented hospital budgets which have resulted in the true costs of single

use and reprocessable devices being obscured from clinicians

• Perception that cost is a more important driver than quality when making

purchasing devices

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Clinicians felt that by cutting costs, patients were put at risk. Cheaper single use

devices were perceived to be placing the patient at greater risk of harm than using a

reprocessable device. We recommend that these perceptions are addressed, both

substantively through the design and cost of devices, and educationally, via an

awareness programme aimed at clinicians.

A fundamental question that has arisen from this research is how to deliver the best,

safest care to patients and at the same time protect the NHS from the higher costs

associated with such practice. Is it appropriate, for example, to continue to

repeatedly purchase and discard certain, non-invasive single use devices (which are

likely to pose very little iatrogenic risk) when the NHS is in financial difficulties? Is it

possible to balance known financial risks against unknown risks of contracting an

iatrogenic infection linked to the use of a medical device? Which is more of a threat:

financial disaster or the potential for patient harm?

Single use devices are beneficial in that they protect against iatrogenic cross

infection and contamination, and ensure that each patient has clean instruments

used on them. This research clearly demonstrates that clinicians feel that the use of

single use devices is in the patient’s best interest. The use of single use devices is

seen to be a sign of clinicians’ professionalism and adherence to good clinical

practice standards. However, as our data demonstrates, single use devices do not

always function as well as clinicians would want them to. Some are unfit for use and

can endanger the patient.

It is not our aim in this report to blame or identify individuals who have admitted to

reusing single use devices. The opportunity for shared learning and improvement in

the design and use of medical devices is a greater good. This report and its

Appendices outline the processes leading to the misuse of devices, as well as

providing a forum for clinicians to voice their concerns. It is now for the regulators

(including the Department of Health, Medicines and Healthcare products Regulatory

Agency and the National Patient Safety Agency), manufacturing community, Royal

Colleges and Royal Associations, front line clinical staff and NHS managers to work

together to address the problems and weaknesses identified in this report. However,

we offer the following nine suggestions:

1. Professional associations and Royal Colleges should work together to address

inconsistencies in infection control guidelines. In particular:

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a. Use of single use laryngoscope blades

b. Contrasting guidance for different invasive intubating equipment

(laryngoscope, laryngeal mask, bougie)

2. Clearer microbiology guidance is required on the actual threat of vCJD and other

iatrogenic infections from reused devices

3. The definition of single use should be re-examined. Do the terms ‘single use’

and ‘single patient use’ describe the same expected usage pattern? If so, we

recommend that the term single patient use is removed from all devices.

Additionally, regardless of the resulting definition, a high profile educational

campaign targeting all stakeholders should be designed and implemented

4. Labelling inconsistencies need to be addressed:

a. Labelling on each device should be consistent. For example, a device

should not be labelled as both single use and single patient use

b. Labelling on the device, packaging and paper insert (instructions) should

be consistent

c. Size of single use logo, font and position of the logo should be examined

d. Use of wording to replace single use logo should be examined

5. Colour coding of devices, thus differentiating between single use and

reprocessable should be investigated. Views of users, purchasers and

manufacturers will need to be sought

6. Robust system for the replacement of breathing circuits after seven days to be

designed and implemented throughout the health care system

7. All clinical stakeholders should revisit EGBAT’s fifth recommendation, regarding

removing devices from their packaging prior to use. Practice should be amended

where at odds with proposal

8. MHRA and device manufacturers to seek independent scientific expertise on the

contamination risks of certain single use devices (such as blood pressure cuffs

and pressure infuser bags) and remove the single use logo if evidence suggests

that this is feasible

9. All parties should look for ways to remedy the perceived quality/cost conflict.

Equipment must be fit for purpose in order to be both cost effective and protect

staff and patients against infection / cross contamination

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Introduction

Patient safety has become a matter of increasing concern to the National Health

Service (NHS), both to reduce litigation risks and costs and to demonstrate the

delivery of a high quality service to users. Following the Chief Medical Officer’s

report, An Organisation with a Memory1, the government created the National Patient

Safety Agency to champion learning from critical incidents and to encourage

systematic institutional attention to the identification of safety risks and the

development of methods for their prevention.

This report focuses on one identified source of risk: the reuse of medical devices

intended to be used on a single occasion. Reuse of these devices is believed to

increase the chances of cross infection and device failure.

This research, commissioned by the Department of Health’s Patient Safety Research

Portfolio, has three objectives:

1. An inventory of single use devices reported as being reused

2. A survey to investigate current practice

3. An in-depth qualitative study of reusers’ and non-reusers’ rationales for reuse

of single use devices.

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Part One: The Inventory

An inventory of published accounts of the reuse of single use devices (SUDs) was

compiled through a search of the scientific literature (June - September 2004;

updated June 2006). It was necessary to restrict the cases to those reported in

Western societies, as reuse may be considered a more acceptable practice in less

developed countries due to a lack of financial and material resources. The inventory

data derives from reported cases of SUD reuse in the UK, the European Union, North

America and Australasia.

Using a popular citation index (PubMed), the following search terms were

investigated:

• Reuse of single use (medical) devices

• Reprocessed single use (medical) devices

• Recycled single use (medical) devices

Reports were only included in the inventory if they were published in the English

language and had online full-text availability. These criteria were selected to specify

the task in the most replicable and accessible manner. While it is possible that a

different strategy would have resulted in a different outcome, the inventory included

the main high-ranking journals from the ISI Web of Science. The use of PubMed

citations, in conjunction with International reports and documents, allows us to be

confident that we have an accurate picture of the data available at the time.

477 reports of reuse were found, although this figure contains many repeated

devices. In total, 291 single use devices were reported as being reused. A full version

of the inventory (listed both by device and country) can be found in Appendix one;

this is also supplemented by a full reference list. An overview of the inventory data is

presented in Table 1.

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Table 1: The most frequently reported devices

Surgical Devices:

• Catheters (N=95)

• Needles (N=41)

• Laparoscopic instruments (N=34)

• Biopsy forceps (N=27)

• Endoscopic instruments (N=17)

• Trocars (N=12)

• Syringes (N=10)

• Diathermy instruments (N=10)

• Burrs (N=9)

Anaesthetic Devices:

• Breathing filters and associated

devices (N=22)

• Breathing circuits (N=7)

• Endotracheal tubes (N=6)

• Oxygen masks (N=5)

• Laryngeal masks (N=2)

The majority of cases of reused SUDs derived from the USA (N=207) and Canada

(N=60). However, reprocessing of (re)used single use devices is permitted in both

countries. In the USA, prior to 2000, hospitals were able to reprocess SUDs ‘in-

house’ through the use of bench-top sterilisation units and central sterilisation

departments (CSDs). However, concerns regarding insufficient safety data led to

such activity being regulated. Post 2000, the USA Food and Drug Administration

(FDA) have issued regulations to which all third party reprocessors and reprocessing

hospitals are required to conform2. Reprocessors (both in-house and third parties)

take on the responsibilities once held by the original equipment manufacturers

(OEMs), and thus become liable should an adverse event arise because of the use of

a reused SUD. Canada does not regulate the reuse of SUDs3. Whilst the

governments of Australia and New Zealand recommend that reuse should not occur,

evidence suggests that reuse is taking place (Australia: N=31; New Zealand: N=15).

Despite the Medical Devices Directive (MDD) 93/42/EEC4, reports suggest that reuse

is still occurring throughout Europe. Reports of reuse originated from Germany

(N=37), the UK (N=20), European Union umbrella organisations (N=19), Denmark

(N=14), Sweden (N=2) and Italy (N=1), despite the implementation of the MDD in

national regulations throughout the EU. However, the onus of the MDD regulations is

placed on the device manufacturers, who are required to prove that the device is safe

and fit for its intended purpose. There is little in the MDD about reuse by clinical staff,

although individual EU member states have made provision for reuse in their own

regulatory systems. Denmark went further than merely advising against reuse, and

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described reuse as ‘substandard practice’5 whilst the UK’s Medicines and Healthcare

products Regulatory Agency (MHRA) states that reuse must not occur under any

circumstances6. Germany allows SUD reprocessing but demands that evidence of

the device’s safety is obtained before reuse3. In Sweden, the physician reusing the

device is held liable for any adverse event, and the patient must consent to the use of

a reused SUD.

The inventory has demonstrated that, despite guidance to the contrary, SUDs have

been reused in countries where such practice had been outlawed. However, a

secondary outcome of the inventory is the finding that regulators and clinicians in

some countries appear to consider that there is little risk involved in reuse.

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Part Two: The Survey

The second phase of the research aimed to explore the reuse of SUDs within the

context of the English NHS, and in particular, operating and anaesthetic departments

within the acute sector. In order to accomplish this, a survey tool was utilised.

The commissioners requested that a sufficiently large survey be carried out to

establish the incidence and prevalence of the reuse of single use medical devices in

theatre and anaesthetic departments, and that the survey should target ‘relevant

frontline staff’. Preliminary investigation identified approximately 350 NHS hospitals in

England with surgical theatres and anaesthetic departments. Given the size of the

population, it was considered practicable to invite all of them to participate in the

initial survey.

The aim of this survey, then, was to establish:

1. The incidence and prevalence of the reuse of single use medical devices in

theatre and anaesthetic departments.

2. The categories of devices involved.

The survey would collect documentary, attitudinal and explanatory data about the

reuse of SUDs in English operating theatres and anaesthetic departments. Jupp et

al7 describe how self-report surveys are an option for uncovering hidden crime

figures and our approach drew extensively on the experience of criminological

research in inviting respondents to disclose deviant behaviour.

We originally planned to use telephone contacts with theatre managers and clinical

directors of anaesthesia to identify appropriate informants for each hospital (i.e. staff

who were likely to know about the extent of reuse). This would yield a sampling

frame of approximately seven hundred health professionals, who would be asked to

participate in the survey. We hoped to achieve a response rate of 30-40 per cent.

The inclusion of two informants per hospital would allow us to achieve a higher

proportion of hospitals, with the possibility of internal error checking where both

responded from the same site. The respondent hospitals could be compared with

published statistics on the population of hospitals to determine whether they could be

considered to be a representative sample or in what ways they might be skewed by

size, type or location.

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Three survey methods were considered for this study:

• Postal surveys

• Telephone surveys

• Web-based surveys

Postal surveys can achieve wide population coverage at a relatively low cost8.

However, the method often leads to low response rates and questionnaires may be

returned with illegible writing9. Previous research investigating the reuse of SUDs via

postal surveys has reported response rates of 57%10, 43%11, and 40%12. However,

McAvoy and Kaner13 caution that response rates for postal questionnaires involving

doctors have been falling. They suggest that reasons for this include: being swamped

by the volume of questionnaires arriving on their desks; doctors resenting

interference in their activities by outside researchers; the length of questionnaires;

and the time taken to participate in research.

Given this obstacle, a telephone survey was considered, but rejected given the

sensitive nature of the survey questions, and the concern that participants might find

the method unduly intrusive. This approach is also less conducive to anonymisation.

Finally, we considered a web-based survey. This method has recently been favoured

when researching health professionals14. Whilst more expensive to set-up than paper

questionnaires, web-based surveys offer many advantages: they are highly cost

efficient because of the elimination of paper and postage, whilst providing the

opportunity for rapid coding and analysis15,16,17,18,19. Moreover, Joinson20 has argued

that respondents are more likely to be “disinhibited” when responding to web-based

surveys, and more willing to share sensitive information. Umbach17 reinforces this

line of argument, suggesting that respondents are more likely to respond to socially

threatening questions because of the perceived distance between researcher and

respondent. While Flatley21 cautioned about difficulties that respondents may face

regarding their ability to use the internet, we reasoned that, since our sample would

need to be computer literate in order to perform their jobs successfully, such a

problem would not arise.

The survey was designed in collaboration with the University of Nottingham Survey

Unit, acting as sub-contractors. It aimed to produce estimates of the prevalence of

reuse and identify possible variations in incidence associated with hospital types.

24

Questions addressed the types of devices that may be reused and the specific

contexts within which this might occur. Given the perceived sensitivity in reporting

reuse of SUDs, it was likely that some under-reporting would occur, as respondents

sought to protect both themselves and their colleagues. Consequently, the question

wording was designed to normalise reuse, reducing any threat or negative

association with reporting. ‘Census-type’ questions would also be asked about the

mix of specialties, volume of operations, hospital location (urban, suburban, rural)

and involvement in teaching.

The questionnaire was piloted by members of the Association of Anaesthetists of

Great Britain and Ireland (AAGBI) council, and the anaesthetic teams at York District

Hospital and Nottingham University Hospitals. Recommendations following piloting

included reducing the length of the questionnaire and clarifying the wording of some

questions, so that participants were more likely to feel able to admit to ‘deviant’ acts

based on their own experience or knowledge of colleagues’ experiences.

The final version of the questionnaire comprised 16 questions about: the participant

(job title, level of experience); the hospital they were employed in (geographical

region, number of beds, theatres, and operations performed each year); the reuse of

SUDs (definitions, experience of reuse, rationales for reuse, awareness of policies

and guidance against reuse; and the possible dangers of reuse). The majority of

questions were closed-ended, with participants responding using check boxes and

Likert scales. A minority of questions were open-ended and required participants to

enter textual answers.

The survey went ‘live’ on 29th September 2004. Despite the web pages being tested

by the Survey Unit, respondents reported a few minor technical hitches, which were

immediately rectified.

Our commissioned design for a nation-wide survey of hospitals proved unworkable,

due to NHS research governance regulations. The need for individual Trust approval

made it impossible to carry out the planned survey within the funded time and

resources. This imposed a change in research design. Rather than recruiting our

sample through NHS routes, we used the membership lists of the professional

associations for relevant healthcare staff working within theatres and anaesthetic

departments.

25

This change introduced two important limitations. First, it was impossible to relate

respondents to their workplaces so that the relationship between the sample and the

population was unknowable, preventing the realisation of the commissioners’ original

goal of estimating incidence and prevalence. Second, there is a greater risk of bias

because those responding were likely to have done so because they were interested

in single use devices, or felt that they had a particular story to tell, rather than

participating solely in their official capacity as NHS employees. We sought to mitigate

the impact of these factors by adopting a more formal case-control design for the

interview phase. An account of the original plans and a detailed explanation of the

new sample design and recruitment strategy can be found in Appendix two.

Survey data were collected over a period of 76 days (29.09.04 – 15.12.04). We

received 113 responses in total, which represents a response rate of just over 1%

(total invitations sent was 10,119, plus an unknown number of responses to an

advertisement placed in The Operating Theatre Journal). 22 of these responses were

considered ineligible because the respondents were not working in the English NHS.1

The following discussion focuses solely on the 91 eligible responses. Respondents

identified themselves in the following manner:

Table 2: Occupational Characteristics of Survey Sample

N %

Nurse 41 45

Anaesthetist 33 36

ODP 11 12

Theatre Manager 6 7

Surgeon 0 0

Total 91 100

The failure to recruit any surgeons is disappointing, and has undoubtedly influenced

the results. However, as Appendix two makes clear, this lack of engagement was not 1 Whilst interesting, these 22 cases have been removed from the main dataset, in

order that the remaining data not be ‘contaminated’ by cases that did not meet the

sampling criteria. A brief discussion of the ineligible data can be found in Appendix

three at the end of this report.

26

planned, but resulted from a logistical breakdown, or apparent indifference towards

the topic among the target population.

The majority of the participants had been working in their role for over one year

(97%), with just under 95% at their current place of employment for over a year.

Explanations for reuse have noted the different guidelines that exist in different

hospitals, despite the general regulatory advice from the MDA2 6. However, it is

reasonable to assume that experienced staff will be aware of the MDA guidelines.

Additionally, 69% of respondents had worked in their post for more than five years,

and so would have experienced the change in procedures involving SUDs/reusable

devices for Tonsillectomy and Adenoidectomy in 200122, and would therefore be

aware of the debate regarding the usage of single use devices and patient safety.

Responses were received from all eight geographical regions in England:

Figure 1: Geographical Characteristics of Survey Sample

2 The current guidance on the use of single use medical devices was published in

2000 by the Medical Devices Agency6. Subsequently, the Medical Devices Agency

(MDA) has been merged with the Medicines Control Agency (MCA), forming the

Medicines and Healthcare products Regulatory Agency (MHRA).

16%

10%

10%

9% 11%

13%

12% 19%

27

57% of respondents defined their place of employment as falling within an urban

area, followed by 33% falling within a suburban area, and 10% in a rural location.

Participants were more likely to be employed in hospitals with over 300 in-patient

beds (70%) and over ten operating theatres (52%). 23% of respondents worked in

hospitals which performed less than 5,000 operations per year, and 25% of

respondents in hospitals performing over 20,000 operations per year.

The quantitative data resulting from the questionnaire has been analysed using

SPSS 3, whilst the textual, qualitative data has been thematically analysed.

Results

The survey data reinforce our finding from the scientific literature that there is little

consistent understanding about what ‘single use’ or the single use logo means in

practice.

Respondents were given five different definitions of SUD, all taken from the literature

(‘single patient’, ‘single episode’, ‘used on a single occasion within a single episode’,

‘non-reprocessable’ and ‘disposable’), and asked to tick all that they considered

relevant to the term ‘single use device’ (Table 3). They were also able to elaborate

upon their response if they wished.

Table 3: Single use definitions

N %

Single patient 70 77%

Single episode 50 55%

Used on a single occasion within a single episode 25 27%

Non-reprocessable 62 68%

Disposable 66 73%

As Table 3 illustrates, the majority of respondents considered ‘single patient’ (77%),

‘disposable’ (73%) and ‘non-reprocessable’ (68%) to be terms that they would use to

3 Preliminary statistical analysis was performed by Dr Rowley and the University of

Nottingham’s Survey Unit. More detailed statistical analysis was performed by

Stephen Bush.

28

describe a SUD. There was less support for definitions that referred to a single

episode of use (54%), and even less for the definition that fits the manufacturing

industry’s recommendation of ‘to be used once and then discarded’, that of ‘to be

used on a single occasion within a single episode’ (27%).

Few participants offered any elaboration upon their understanding of the term ‘single

use device’ (N=5). The explanations that we received were all similar, which is

surprisingly given the inconsistency in the definitions offered in the scientific

literature. However, none offered a definitive explanation of the term ‘SUD’.

According to our survey respondents, the meaning of the term ‘single use device’ is

dependent upon the specific device in question. For example, “a device may or may

not be a single use within an episode - depends on device. e.g. an IV cannula is

single use within episode, a disposable PCA pump is single patient but often refillable

for that patient” (ID 80 / Anaesthetist). Moreover, given the similar level of support

that single patient, non-reprocessable and disposable received, it is likely that “all

[terms] may apply dependant on the item, its use, whether sterility is required and the

likelihood of damage occurring during use” (ID 89 / Anaesthetist).

The data demonstrates that there is no agreed definition of a SUD, and strengthens

our argument that there is little objective understanding regarding what ‘single use’

should be recognised as meaning. Moreover, in light of the gulf in levels of support

for ‘single patient use’ (77%) and ‘single use’ (27%), it is apparent that in clinical

practice, ‘single use’ and ‘single patient use’ are considered to be different

phenomena.

Although the MHRA6 acknowledge that manufacturers intend that SUDs should “be

used once and then discarded [and] consider the device is not suitable for use on

more than one occasion”, their own definition is inconsistent with this, as the

following definition of ‘single use’ illustrates:

Single use – The medical device is intended to be used on an individual

patient during a single procedure and then discarded. It is not intended to be

reprocessed and used on another patient. The labelling identifies the device

as disposable and not intended to be reprocessed and used again (p.14)

The MHRA’s own definition of ‘single use’ makes a distinction between use on a

single procedure and the intention that the device should not be reprocessed and

29

used on another patient4. However, this definition differs from the manufacturers’

approach, in the first definition quoted by the MHRA. In highlighting this subtle

difference, we draw attention to the possibility for confusion. The manufacturers’

definition is clear: the device is designed to be used on a single occasion. However,

the MHRA’s definition implies that single use can be taken as meaning single patient

use during one procedure. Their definition is supported by further explanations of

‘reuse’ and ‘single patient use’, which both describe the second and subsequent use

of a SUD that either has, or may have, been reprocessed (cleaned / sterilised)

between usages. There is also an issue with how to define a ‘single procedure’. For

some procedures the length of usage may be quite short, while for others it may be

lengthy and periodic. For example, a single use facemask will be transferred with the

patient back to the ward following surgery. The facemask will be used solely by that

patient, but the period of usage may span several hours. Moreover, there is a risk of

infection from the facemask being transferred from the theatre and recovery suite to

the ward environment, where greater numbers of patients could become exposed to

the risk that the reused facemask might present.

Whilst only a small difference, the lack of consistency between the two definitions

may result in patient harm. Anecdotal reports suggest that there have been cases of

scalpel blades snapping and needles becoming blunt through extended use, but with

the usage pattern falling within the MHRA definition – used on a single patient and

not reprocessed (Personal communication with manufacturing representative). We

suggest that this definitional inconsistency requires attention. Such variation can

have an impact upon patient safety, as SUDs are not designed or manufactured to

be used on more than one patient or undergo any form of reprocessing.

4 The MHRA have subsequently altered their definition of 'single use' (see DB

2006(04) Single-use Medical Devices: Implications and Consequences of Reuse).

The definition now reads: “a device designated for single use must not be re-used. It

should only be used on a single patient during a single procedure and then

discarded. It is not intended to be reprocessed and used again, even on the same

patient”. This has clarified the difference between single use and single patient use.

However, we have not altered our argument in the text, as this definition was not

operational when the data discussed in this section was collected. Rather, the

definition seen in MDA DB 2000(04) was still utilised.

30

Respondents were asked to list SUDs that, to their knowledge, had been reused at

their hospital either by themselves or by colleagues. They were also asked how

frequently they thought the devices were being reused 5. 62% of respondents were

able to report reuse. The SUDs reported as being reused, and the frequency of such

reuse occurring is shown in the following chart:

Table 4: Reused SUDs

Total

(N)

Every

operation

More

than

once a

week

More

than

once a

month

More

than

once a

year

Unknown

Anaesthetic breathing

systems 37 22 13 2 0

0

Facemasks 17 5 9 1 0 2

Circulation /

Compression garments 13 5 7 1 0

0

Monitoring / Sampling

lines 12 10 2 0 0

0

Intubating bougies 11 2 4 4 1 0

Laryngoscope blades 6 3 1 1 1 0

Pressure infusion bags 4 0 3 0 1 0

Syringes 4 3 0 0 0 1

Probes 4 1 1 1 1 0

Diathermy equipment 2 0 2 0 0 0

An outcome of the recruitment strategy, and the lack of participation from surgeons,

is that the SUDs reported as being reused are predominantly found in anaesthesia.

127 reports of reused SUDs were received. These described the reuse of 13

anaesthetic devices, ten surgical devices, and seven devices that are neither solely

used in surgery nor in anaesthesia. The ratio of reuse reported for SUD anaesthetic

and surgical devices is 89:11.

5 The question was worded to gain data on the patterns of reuse, rather than the

number of times a particular instrument might be reused. At present, it is impossible

to collect data on the frequency of reuse for individual SUDs, as records are not kept.

31

A further limitation of the recruitment method has been the inability to draw any

statistical inference from all but a few of the relationships expected between reused

SUDs and the rationales given to explain such practice. For example, it is impossible

to demonstrate that there is an association between the reuse of a SUD, the number

of procedures carried out in which the SUD is used and the rationale that reuse

occurs due to the prohibitive cost of replacing the SUD each time.

The most frequent device reported as being reused

was the anaesthetic breathing system (N=37). 22

individuals reporting reuse considered that anaesthetic

breathing systems were likely to be reused in every

operation. It is known that anaesthetic equipment

shared between patients poses a risk of cross-

contamination23,24,25,26. For example, in 1993 an Australian hospital reported the

nosocomial infection Hepatitis C in five patients whose anaesthetic therapy was

provided using a reused breathing circuit27. Consequently, breathing circuits became

labelled as ‘single use’.

However, while the extent of reported reuse may seem surprising, the reuse of

breathing circuits has now been sanctioned in the UK. The AAGBI28 has endorsed

the reuse of single use breathing circuits on than one patient and for more than one

operating session, if the circuit is protected by a new breathing (bacteria/viral) filter

for every patient. To this extent, manufacturers now market their breathing circuits as

being able to withstand limited reuse. For example, Flexicare Medical sell their

breathing circuits without a symbol or wording restricting them to single use, and

suggest that circuits then require the use of a suitable Breathing Filter between the

patient and breathing circuit, with the Breathing Filter being discarded after each

patient29. Intersurgical describe the “limited repeated use” of single use breathing

circuits, on condition that all reference to ‘single use’ is removed from the packaging

and instructions, and a single use breathing filter is used30. It is assumed that it is this

kind of reuse that respondents have reported.

32

Breathing filters are placed at the Y-piece

of the breathing system, and prevent the

patient from inhaling hazardous or

infectious particles whilst the upper

airways are bypassed33.

Manufacturers now advise that anaesthetic breathing systems can be reused for up

to a one week, subject to a new single use breathing filter being used for each

patient29,31. NHS Purchasing and Supply Agency35 endorsed this reclassification, and

provided the following statement:

Following lengthy consultation between the Medical Devices Agency, the

Royal College of Anaesthetists, the Association of Anaesthetists, product

manufacturers, BAREMA, and the NHS Purchasing and Supply Agency,

agreement has now been reached on the principle of limited repeated use of

breathing systems.

It is understood that this change in reclassification was brought about following a

meeting between the MDA, AAGBI, Royal College of Anaesthetists (RCOA), NHS

PASA and BAREMA in Summer 2001, in response to the publication of the MDA’s

Device Bulletin DB2000(04)6,36. It seems that limited reuse of breathing circuits

labelled as single use, providing they were protected by a new, single use breathing

filter for each patient, had been a long-standing practice. Smith and Birks37 described

how:

In most anaesthetic departments, in conjunction with a single use disposable

bacterial/viral filter, an anaesthetic breathing system designated single use is

often used for one list, one day or even for one week. The perceived risk of a

Breathing Filters are designed to prevent

microbial cross contamination of the

anaesthetic breathing system, from both

the patient to the machine, and vice

versa31,32.

33

patient contracting a disease such as a prion disease from anaesthetic

breathing systems is exceptionally small, whilst the cost of replacing all the

tubing and other parts of the anaesthetic breathing system for each individual

patient is high.

Although no official statement on the ‘limited reuse’ of breathing circuits has ever

been made by MHRA, all parties agreed to the limited reuse of breathing circuits on

condition that such reuse was sanctioned by the notified bodies. BAREMA made the

following statement38:

This statement is intended to clarify the current position regarding the supply

and use of anaesthetic breathing circuits. Up until August 2000, it was the

common practice in most UK hospitals for anaesthetic breathing circuits to be

used for more than a single case – e.g. anything from a list to several days,

even if the circuits were originally supplied for ‘single use only’. In August

2000, the Medical Devices Agency publication DB 200 (04) reiterated that any

product sold by a manufacturer for ‘Single Use’ should not be used for more

than one patient. Since August 2000, there has been considerable debate

between users, MDA and suppliers on the practice to be adopted in hospitals.

Under the requirements of the Medical Devices Directive, it is the

responsibility of the manufacturer to specify how products are to be used and

be able to demonstrate to independent authorities (namely Notified Bodies)

that the appropriate validation for that use has been done. During the recent

past a number of suppliers in the UK have been able to show that anaesthetic

breathing circuits can be safely reused and are now selling these products

with appropriate instructions to be followed in hospitals. It is expected all

suppliers of circuits will be selling for reuse in the next few weeks.

The notified bodies were satisfied with the reclassification proposed, on proviso that

all reference to single use would be removed from breathing circuits36.

One respondent reported the reuse of paediatric breathing circuits, providing the

circuit was protected by a ‘Pall’ BB25 filter (ID 104 / Anaesthetist). Reuse was

reported to occur more than once a week. Currently, paediatric breathing circuits, like

their adult counterparts, can be reused if a single use breathing filter is utilised.

34

The respondent referred to the use of a BB25 filter manufactured by Pall Medical,

who describe their filter as offering effective barrier with bacterial/viral removal

efficiency of 99.999%. However, the scientific literature has reported that paediatric

breathing filters are not as effective as their adult equivalent in reducing risk of cross-

infection32,33,34. In the light of this, debate between the manufacturers and paediatric

anaesthetists is ongoing38, and it is likely that paediatric breathing circuits will

become single use.

Referring to the ‘reuse’ of breathing systems with the use of a new breathing filter for

each patient, Bennett and Bingham39 advise that, until new guidelines can be issued,

clinical end users must be aware that “in the absence of a written local policy to the

contrary, reuse of single use equipment, even with a filter, remains the responsibility

of individual practitioners”. A risk assessment carried out by North Lincolnshire and

Goole Hospitals NHS Trust, has led to the sanctioned reuse of breathing systems if

the devices are used in conjunction with breathing filters40. If this guidance is

followed, then the Trust will accept liability for reuse.

Wilkes33 reported that, in a 1993 outbreak of nosocomial Hepatitis C in Australia, “it

was hypothesized that an infected patient had coughed secretions into the breathing

system which then acted as a reservoir of infection for subsequent patients”.

Breathing filters were not used during the operating list that led to this incident.

Wilkes conjectured that “if filters had been used, cross-infection might have been

prevented by intercepting either air-borne particles or contaminated liquid”.

Given the risk of transmission of bacteria and viral infectious particles, a new, single

use breathing filter should be connected to the anaesthetic breathing circuit, at the

patient end of the circuit for each new patient. The breathing filter acts to protect the

patient “from any microbes that may be present in the breathing system delivering

gases to their lungs. A filter can also reduce the likelihood of microbes passing from

the patient’s respiratory tract to the breathing system”32. Given that the filter acts as a

barrier that prevents infectious particles reaching the patient, and or the breathing

circuit, it is recommended that “anything between the filter and the patient should be

disposed of or sterilised appropriately after use” 29,34.

Atkinson et al23 carried out a survey of UK anaesthetists to discover the extent to

which breathing filters were used. They found that “seventy-seven per cent of

respondents use a new filter in the anaesthetic circuit for each patient. Filters are

used by 6.5% of respondents for selected cases only (e.g. ‘high-risk patients’), whilst

35

8.7% of units use filters but change them only at the end of each list or day.

However, 6.5% of units do not use filters in the anaesthetic breathing system”. As

anticipated, none of our survey respondents reported the reuse of a breathing filter,

and it is assumed that in all cases, the manufacturer’s guidelines permitting limited

reuse were followed.

Many respondents chose to justify their reuse of single use breathing circuits, with all

referring to the use of a filter used in conjunction with the breathing system. It was

also emphasised that circuits were changed weekly in line with the manufacturer’s

recommendation. For example, “we are using the Mapleson C circuits in recovery. As

long as they have been used with HME filter in situ on every occasion our managers

allow reuse for one week. They are dated when opened for use and dated when

change is due. The manufacturers (we are told) guarantee them for this period so

long as they are used with filters” (ID 41 / Anaesthetic Recovery Nurse), and

“anaesthetic circuits are reused because we use disposable catheter mount and

filters. They are changed once a week in line with manufacturer recommendation” (ID

103 / Anaesthetist).

Given the protection afforded by breathing filters, in addition to the evidence in the

literature, the reports of reused breathing circuits are not surprising. However, it is

interesting that end users felt the need to report such reuse, albeit emphasising the

use of single use breathing filters. Such reporting illustrates that end users still

consider breathing circuits to be potentially single use, when they are now reusable

and underlines the continuing confusion over definitions in the community.

Consequently, it is possible that the labelling or guidance provided with the device

needs to be altered to reflect the limited reuse of adult breathing circuits when used

in conjunction with breathing filters. We return to this point later in the report, in

respects to the role that labelling inconsistencies can play in the event of SUD reuse.

The latest edition of the AAGBI’s Checking Anaesthetic Equipment41 guide suggests,

“any part of the breathing system, ancillary equipment or other apparatus that is

designated “single-use” must be used for one patient only, and not reused. Many of

the remaining devices reported as being reused fall within this broad range of

equipment.

36

The second most frequently

reported devices being

reused were facemasks

(N=17).

Of these 17 reports, 12 referred to facemasks used for oxygen therapy, and 5

mentioned anaesthetic facemasks. Respondents were most likely to report that

facemasks were reused in every operation (N=5) or more than one a week (N=9).

When separated into each type of facemask, the reported reuse had similar patterns

(Table 5):

Table 5: Reuse of Facemasks

Total

(N)

Every

operation

More

than

once a

week

More

than

once a

month

More

than

once a

year

Unknown

Anaesthetic Facemask 5 2 3 0 0 0

Oxygen Facemask 12 3 6 1 0 2

Both types of mask are intended to be single use, yet, in practice, an oxygen mask is

likely to be classified as single patient use. Although one respondent considered

there were “no perceived risks” to the reuse of facemasks, and that they could be

“socially cleaned” (ID 90 / Anaesthetist), they are known to pose a threat of cross

infection due to contamination by patient secretions26,29. During the pilot phase of the

project, anaesthetists were observed re-using single use anaesthetic masks that had

been ‘cleaned’ by the ODP using an alcohol wipe. Following ‘cleaning’, the mask was

placed unwrapped on the anaesthetic machine for reuse on the next patient.

Given the large volume of anaesthetic inductions performed, is it realistic to expect

SUD anaesthetic masks to be discarded after one use? Does this device require

reclassifying, or is there a real threat of cross infection? If the risk of cross infection is

so great, then why are anaesthetic facemasks reused at all? The answers to these

questions are outside the remit of this report, but we suggest that a microbiological

study of the risks relating to the reuse of masks may be desirable.

37

Monitoring and Sampling lines are used to examine

the gases that are delivered and exhaled during

anaesthesia. Monitoring provides essential

information to the anaesthetist about the patient’s

pulmonary function whilst they are ventilated.

Sampling lines are labelled ‘single use’ as it is possible for patient secretions to

collect in the tubing. Despite such concerns, sampling and monitoring lines were

reported as being reused. Ten respondents reporting such reuse considered that this

was likely to occur in every operation.

A range of intubation devices, including bougies, laryngeal mask airways (LMAs) and

laryngoscope blades were reported as being reused, despite their ‘single use’

labelling.

11 respondents reported the reuse of single use elastic gum bougies. These devices

are also referred to as Endotracheal Tube Introducers, Endotracheal Stylets and

Bougies. They are used to enable the anaesthetist to gain directional control when

experiencing a difficult intubation. Bougies carry a risk of cross infection, as the

device “has the potential to introduce pathogens into the respiratory tract”42. In his

examination of used bougies, Cupitt46 reported incidences of Coagulase -ve

Staphylococcus, unknown species of Staphylococcus, Diphtheroids, Bacillus species,

Micrococcus, Coliform, and Fungus growing on bougies. Shah et al43 have found

similar levels of bacterial contamination, and report concerns that such contamination

may lead to greater incidences of iatrogenic pneumonia6.

There is also a risk of viral transmission of disease via cross contamination from

blood residue on the outer structure of the bougie. Philips and Monaghan44 found

residual blood contamination on 40% of ‘clean’ laryngoscope blades awaiting reuse,

and Smith45 described blood contamination of the handle. Given that the bougie is

often used in collaboration with a laryngoscope, it is reasonable to expect a similar

extent of residual blood from the patient’s respiratory tract to remain on the bougie.

6 It is recognised that iatrogenic pneumonia can be caused by ventilation and airway

manipulation46. Shah et al43 consider that the presence of contaminated bougies

creates a further risk of infection.

38

Despite the risk of bacterial and blood borne cross contamination, two respondents

reporting the reuse of bougies considered that reuse was likely to occur in every

operation, while another four thought that reuse was likely to take place at least once

a week or more. One respondent provided a rationale to explain their reuse of a

single use bougie, describing how there is “no suitable alternative of sufficient quality”

(ID 103 / Anaesthetist).

Bougies are manufactured in both reusable and single use forms. Reusable bougies

can be used up to five times if disinfected between patients28. However, as Cupitt42

notes, “no formal record is kept of their use, therefore each bougie is probably used

many times. [Moreover] since they function perfectly well after five uses, is the

indication for discarding them an infection issue or does it relate to actual physical

deterioration? With repeated use, localised areas of weakness can develop in the

outer layer of the bougie. In many hospitals they are only replaced when actual

damage becomes visible”. The reuse of bougies beyond their intended lifespan is

clearly a threat to patient safety. Given that Cupitt describes the deterioration of

reusable bougies, and our respondent rationalised reuse in terms of the lack of

another device of suitable quality, it seems as if the manufacturing and design of

bougies could be examined in order that reuse cannot be justified in relation to

quality issues.

Six respondents reported the reuse of a single use laryngoscope, with three of them

considering reuse to occur in every operation. Laryngoscopy is an invasive

procedure by which a blade is placed into the patient’s mouth and throat, enabling

the anaesthetist to visualise trachea when attempting to ventilate the patient, as

figure 2 illustrates.

Figure 2: Position of the laryngoscope.

Source: http://health.allrefer.com/pictures-images/laryngoscope.html

39

Following concerns regarding the possible spread of TSEs and prions (including

vCJD) from the tonsils47,48,49 (see figure 3), single use laryngoscopes were

introduced. Given the proximity of the tonsils and the laryngoscope (

Figure 3), it was suggested that anaesthetists should only single use laryngoscopes

in an attempt to minimise the risk of cross infection28.

Figure 3: Location of the tonsils.

Source: http://health.allrefer.com/health/epiglottitis-throat-anatomy.html

Esler et al50 describe how “mixed cultures have been grown from laryngoscopes

following routine use, including a wide range of potentially harmful micro-organisms.

Laryngoscope blades come into contact with mucous membranes, saliva and blood.

Consequently, cross-infection has been reported28,50. For example, Esler et al

discussed cross-infections deriving from delivery suites and in neonatal intensive

care units involving infection with Listeria monocytogenes and Pseudomonas

aeruginosa. Later in this report, we provide visual evidence of the inability of

reprocessing methods to remove tissue and blood contamination on a single use

laryngoscope blade.

Laryngoscopes are manufactured as both reusable and single use devices, and we

return to this issue later in the report. Reusable examples can be used in conjunction

with either a single use or a reusable blade. Practitioners also have the option to use

disposable sheaths that fit over the blade and the handle. However, even if a new

single use blade is used, patient safety may still be compromised. Esler et al50

describe how, “although the laryngoscope handle does not contact the patient

directly, it may be contaminated by the tip of the blade, which often touches the

handle when in the folded closed position, and hence the handle must also be

40

considered a potential source of cross-infection”. Consequently, any risk analysis of

laryngoscopes must take into account the threat posed by reused handles.

Reuse of laryngeal mask airways (LMAs) were reported by a minority of respondents

(N=4). The LMA allows the anaesthetist to manage the patient’s airway when the

more traditional technique of an endotracheal tube attached to a breathing system,

would interfere with the surgical field. LMAs, in both their single use and reusable

guises, are expensive devices, and are not used in every operation.

Like laryngoscopes, LMAs are placed down the patient’s trachea and thus “have the

potential to act as a vector for the transmission of prion diseases”51. LMAs come into

contact with the patient’s tonsils, which are known to carry a risk of prion

transmission. Parker and Day52 examined 50 LMAs and found blood contamination

on 76% of the devices. However, contamination visible to the human eye was only

found on 12% of devices, demonstrating that instruments which appear to be ‘clean’,

may not be as sterile as anticipated.

Other anaesthetic devices reported as being reused included: capnographs lines,

spirometry tubing, ventilator tubing, green bubble tubing and elephant tubing,

breathing system bags, oxygen bags, pressure infusion bags, anglepieces, C02

adaptors, recovery T-pieces and catheter mounts.

Respondents listed 26 SUDs that although used within the operating theatre, cannot

be clearly categorised as an anaesthetic or surgical device. These include syringes

(n=3), drapes (n=1), circulation / compression garments (n=13), gloves (n=1),

warming blankets (n=1), spinal needles (n=1) and bottles of prep solution and saline

(n=2). Given that the data on the above devices is sparse, any in-depth discussion

about reuse patterns can only be made in regards to circulation and compression

garments.

41

The third most frequently reported category of

device to be reused were circulation and

compression garments (N=13). Although a range of

terms were given to describe the devices, including

‘Flowtron Boots’, ‘gaiter inflation DVT prohylaxis’

and ‘compression garments’, they have been

grouped together in the analysis.

Compression garments are used perioperatively to

aid the patient’s circulation and prevent pooling of

blood at lower extremities of the body. Used post-

operatively, they can aid with DVT prophylaxis.

Five individuals reporting reuse considered it was likely to occur in each operation,

with another seven reporters estimating reuse at least once a week. Compression

garments are likely to be in direct contact with the patient’s skin, but some

respondents considered that the device could be reclassified as reprocessable. For

example, “many ‘single use items’ could actually be simply washed and reused, such

things that are non-invasive and are in contact with unbroken skin. The

manufacturers should alter the design to that can be done safely; for example, with

‘Flowtron leggings’” (ID 77 / Theatre Nurse). Considering that compression garments

are unlikely to come into contact with the clinical site, it is possible that they might be

an appropriate device for reclassification. We suggest that there should be further

examination of this issue.

As already discussed, the lack of participating surgeons in the survey has had an

impact on the types of devices that are reported as reused. Respondents reported

the reuse of just 11 surgical devices, and it is impossible to provide any in-depth

analysis. The devices reported as reused can be categorised as: diathermy

instruments (n=2), laparoscopic instruments (n=1), probes (n=4), saw blades (n=1),

jugs (n=1), buckets (n=1) and “most surgical instruments” (ID 81 / Anaesthetist).

Respondents were asked why they thought SUDs were reused in their hospital, and

could check as many of the factors listed as they wished (Table 6).

Table 6: Rationales for reuse

42

N %

Cost 46 50

No risks involved in reuse 25 27

Don't know / am not aware SUDs are reused 19 21

Waste/environmental issues 18 20

Other 17 19

Only available equipment 10 11

Reuse of SUDs is frequently rationalised in terms of the financial and environmental

impact that results from repeated purchasing and disposal of medical

devices53,54,55,56. The survey showed that 50% of respondents considered that SUDs

were reused at their hospital due to the prohibitive cost of replacing the device after

each procedure. Statistical tests demonstrated that cost was a significant factor in the

decision to reuse breathing circuits (χ2 = 8.26, p < 0.004), facemasks (χ2 = 5.94, p <

0.05) and compression garments (χ2 = 7.04, p < 0.01).

One anaesthetist rationalised the reuse of a single use syringe in terms of the cost: “I

personally reuse syringes on same patient because of cost” (ID 103), whilst another

justified the reuse of a pressure infusor bag because of the financial implications (ID

101).

The average cost of a syringe, according to the NHS PASA catalogue57, is 15 pence.

Although the large volume of use multiplies this cost many thousands of times over,

there are real dangers from reusing syringes. For example, if a syringe is used to

draw medication, and subsequently reused to draw a different medication, the two

substances may react with each other. It is likely that, following its first use, the

syringe is no longer sterile. Whilst undertaking piloting, the reuse of a syringe was

witnessed. A non-sterile syringe was picked up from a tray on the anaesthetic

machine and used to test the inflation of the cuff to a tracheal tube. Once this had

been checked, the syringe was disconnected and returned to the tray for further use.

The cost of LMAs provides a further example of the financial justifications for SUD

reuse. All respondents reporting reuse of a SUD LMA justified the practice on

grounds of cost. Smith45 compared the cost of a single use LMA with its reusable

equivalent. The SUD LMA was reported to cost approximately £27. The reusable

LMA, which, according to the manufacturer, can be sterilised up to 39 times (i.e.

43

disposed of after 40 uses), costs over £80. As discussed earlier, the use of a SUD

LMA is favoured because of the certainty of sterility. However, as Smith states, for

some hospitals, SUD LMAs are “not an attractive financial option”. We shall further

examine the costs differences between single use and reprocessable devices later.

Respondents employed in hospitals carrying out more than 15,000 procedures per

annum were more likely to rationalise reuse of SUDs in terms of the negative

financial impact of the purchase and use of new single use devices for each patient.

44

Table 7: Reuse rationalised according to prohibitive cost of replacing SUDs,

measured against the number of operations performed per annum

N %

999 or less 1 2

1,000 - 4,999 7 15

5,000 - 9,999 5 11

10,000 - 14,999 5 11

15,000 - 19,999 7 15

20,000 or more 12 26

Unknown 9 20

Total 46 100

However, the small sample makes it impossible to test this apparent association.

Haley58a described how, in the USA, a SUD reprocessing programme in a 600 bed

hospital could halve expenditure on devices (Table 8). Although the exact products to

be reused are not identified, Haley works for Vanguard Medical Concepts, a US third

party reprocessor handling arthroscopic instruments, biopsy forceps, EP catheters,

anti DVT garments and laparoscopic equipment58b.

Table 8: Proposed cost savings linked to reuse58a

Number of beds Average savings in US $

100-150 71,910

151-200 137,700

201-300 313,650

301-450 465,120

451-600 639,540

600-1000 755,820

The reuse of SUDs as a financial solution, places a burden on both staff and patient

safety, and on the professional obligations of clinicians. In a recent editorial in

‘Anaesthesia’, Woods59, formerly anaesthetic clinical speciality advisor for the NPSA,

argued that it is up to “practitioners to stand up for themselves and demand that the

safest rather than the cheapest options are considered when purchasing the

materials we use in our daily work”. When questioned, very few clinical practitioners

45

would be happy to have a reused SUD used on themselves or their family60. 82% of

nurses and 71% of surgeons surveyed say they would be uncomfortable if a

reprocessed single use device were used in this context.

However, while some of our survey respondents were resolute that they would

“refuse to accept a reprocessed single use item onto my trolley” (ID 12 / Nurse),

patient safety is compromised by SUD reuse. By placing the patient at risk of cross

contamination or iatrogenic injury and disease, a practitioner is not meeting the

professional obligation ‘to do no harm’. Moreover, placing a patient at risk from a

contaminated instrument is costly. Medico-legal costs associated with unclean,

unsterilised or contaminated surgical devices (whether SUD or reusable), are

estimated to exceed £1.5 million since 1995 (personal communication with NHSLA).

Surprisingly, given its emphasis within the literature12,61 only 18 respondents

considered that waste or environmental issues could justify SUD reuse. One

anaesthetist commented, “I personally reuse syringes on same patient because of

environment issues (ID 103). However, another expressed doubts about the validity

of the environmental argument when rationalizing SUD reuse: “I feel environmental

issues ought to be a reason for reuse but am sure this is not the case” (ID 97).

As with the justification of reuse in terms of the cost of replacing every device,

respondents who justified reuse of SUDs in terms of wastage and environmental

issues were more likely to work in hospitals that performed over 15,000 operations

per year (50%) and would consequently generate greater levels of waste (table 9).

46

Table 9: Reused rationalised in terms of excessive waste, measured against number

of operations performed per annum

N %

999 or less 0 0

1,000 - 4,999 2 11

5,000 - 9,999 1 6

10,000 - 14,999 2 11

15,000 - 19,999 3 17

20,000 or more 6 33

Unknown 4 22

Total 18 100

However, whilst SUDs and their packaging “contribute to the solid waste stream”62,

the reprocessing of reusable devices also has an environmental impact from the

waste generated during sterilisation55. At the end of its lifecycle, the reprocessable

device will still contribute to the solid waste stream, as Schultz62 describes. Repeated

re-packaging following sterilisation also places increased waste into the environment.

25 respondents considered that the rationale for reuse of SUDs was the lack of risk

involved in the practice. For example, one ODP declared that there were “very few

risks from routine patients so some items have always been classed as multi-use

even though they are classed as single use” (ID 92). This respondent reported the

reuse of laryngoscope blades, bougies and facemasks. All these devices have the

potential to come into contact with infectious agents.

It is interesting that staff perceived that reuse of many SUDs does not involve any

real risks. Woollard63 argued that, in the absence of demonstrated adverse effects,

Australian hospitals were not prepared to divert resources from other areas of

medical care to replace equipment. However, research has found evidence of

contamination on surgical instruments56,61,64,65 and it is acknowledged that the long-

term safety and efficacy of reused SUDs has “never been properly proven”66. It is

therefore proposed that it is not solely that there has been an absence of adverse

events linked to surgical devices, but that “patient adverse events directly related to

the reuse of SUDs are often under-reported due to the difficulties in determining the

actual causes of such events, the potential liability issues of such events and the

47

inadequacy of the reporting systems”67. However, many items listed in the inventory

of reuse and reported by respondents, are non-critical, non-invasive devices (e.g.

anti DVT garments such as ‘flowtron boots’). It is likely that the risk of iatrogenic

transmission of disease, bacteria or prions via such devices is indeed extremely low.

Lastly, ten respondents blamed a lack of equipment or the lack of “suitable

alternative[s] of sufficient quality” (ID 101 / Anaesthetist) for SUDs reuse. When we

raised the supply chain issue with manufacturers, they argued strongly that they did

all they could to meet orders and not place patients in danger or risk their company’s

reputation. They claimed that supply problems often occurred in the hospital, either

before they received an order, because of a problem in the hospital’s administration

system, or after the order was despatched and before it was delivered to theatre. The

interview phase of the study investigated these claims further, whilst our ergonomic

analysis reviewed the quality issues.

Collignon et al12 examined the reuse of SUDs in Australia, and found that large

metropolitan hospitals were more likely to reuse (or report the reuse of) SUDs. The

survey data suggests that a similar conclusion could be reached about the reuse of

SUDs in the English NHS. Most SUD reuse was reported from staff who work in

hospitals with over 300 inpatient beds (N=34), and performing over 20,000 surgical

procedures are performed per annum (N=18). Table 10 outlines the relationship

between number of operations performed, hospital bed numbers and SUD reuse.

48

Tabl

e 10

: App

roxi

mat

e nu

mbe

r of o

pera

tions

per

form

ed /

Num

ber o

f inp

atie

nt b

eds

/ Reu

se o

f SU

Ds

N

umbe

r of i

npat

ient

bed

s To

tal

50

or l

ess

51-1

00

101-

150

151-

200

201-

300

Mor

e th

an

300

No

reus

e A

ppro

xim

ate

num

ber

of

oper

atio

ns

perfo

rmed

1,00

0 - 4

,999

3

1 3

1 4

12

5,00

0 - 9

,999

0 0

0 0

2 2

10,0

00 -

14,9

99

0

0 0

1 1

2

15,0

00 –

19,

999

0

0 0

0 2

2

20,0

00 o

r mor

e

0 0

0 0

5 5

To

tal

3

1 3

2 14

23

Reu

se

App

roxi

mat

e

num

ber

of

oper

atio

ns

perfo

rmed

999

or le

ss

0 0

1 0

0 0

1

1,00

0 - 4

,999

0

2 0

1 1

4 8

5,00

0 - 9

,999

2

0 1

0 2

1 6

10,0

00 -

14,9

99

0 0

0 1

0 5

6

15,0

00 -

19,9

99

0 0

0 0

1 6

7

20,0

00 o

r mor

e 0

0 0

0 0

18

18

To

tal

2 2

2 2

4 34

46

49

Respondents were asked whether they thought reuse of SUDs occurred in other

hospitals (Table 11). 25 individuals reporting such a practice thought it was likely to

be occurring in more than 75% of other English NHS hospitals. However, 27 of those

responding to the question thought that reuse of SUDs was only likely to happen in

less than a quarter of all English NHS hospitals.

Table 11: Reuse in other hospitals

N %

75% or more 25 29

50-74% 18 21

25 –49% 15 18

Less than 25% 27 32

Total 85 100

When comparing these responses to their own reported pattern of use or reuse,

respondents whom themselves reported SUDs reuse were more likely to consider

that other hospitals were practising SUDs reuse (χ2 = 25.42, p < 0.001) (Table 12).

Similarly, respondents who did not reuse SUDs thought that other NHS hospitals

were also unlikely to reuse SUDs.

Table 12: Comparing reuse in own and other hospitals

Reuse in other hospitals Total

75% or

more 50-74% 25-49%

24% or

less

Reuse No items

listed as

reused

1 4 8 18 31

Items listed as

reused 24 14 7 9 54

Total 25 18 15 27 85

50

Respondents were asked to respond to the question “what do you think the risks and

dangers of re-using single use devices might be?”. Responses fell into five

categories, which are shown in Table 13:

Table 13: Perceived danger / risk of reuse

N %

Cross contamination and infection 59 65

Device failure 57 63

Inability to adequately clean 23 21

Ethics of care and safety 14 15

Compromising manufacturers guarantee 11 12

Risk of litigation 11 12

59 respondents perceived cross contamination and infection to be a danger or risk

associated with the reuse of SUDs. Of these, 24 were nurses, 21 were anaesthetists,

nine were ODPs and five were theatre managers. However, when compared to the

total number of each occupation within the sample, a different pattern is seen. 83% of

all theatre managers and 82% of all ODPs in the sample were concerned about the

risk of cross contamination and infection from SUD reuse, with anaesthetists (64%)

and nurses (59%) least likely to consider that reuse posed an infection risk.

Statements described “bacterial / viral cross contamination between patients” (ID 1 /

ODP), the “increase risk of cross infection which therefore ignores [the] principals of

universal precautions” (ID 7/ Nurse), “cross infection, CJD etc” (ID 54 / Nurse) and

“infective risk / prion risk” (ID 81 / Anaesthetist).

The argument that reuse could be justified on grounds of the lack of risk was

discussed earlier in this report. However, Collignon et al61 point to the lengthy

incubation period associated with TSE diseases, and argue that linking a subsequent

surgical infection to the reuse of a SUD “will be very difficult”. Our data do show that

clinical end users have real concerns about the possibility of cross contamination and

infection. Moreover, “even a small risk is unacceptable to the patient who acquires an

infection”55, and reuse of SUDs does generate a credible threat to patient safety.

Despite Woollard’s 63 complaint about the lack of scientific evidence of risk from SUD

reuse, cases are beginning to be reported. Bacteria have been found on ablation

51

catheters665, gum elastic bougies42, endoscopic biopsy forceps64,68 and anaesthetic

ventilators25.

In recent years, two cases of reuse of contaminated surgical devices have occurred

in England, and received high profile media coverage. Whilst it is unclear whether the

devices in either case were SUDs, they demonstrate how even instruments that are

designed to be decontaminated can lead to cross-contamination and infection

transmission between patients. The risk of contamination to instruments that are not

designed to be cleaned and sterilised, may, then, be very real.

In 2001, Alan Brant underwent a procedure to dilate his oesophagus at St Peters

Hospital, Chertsey. During the procedure, a biopsy was taken and found to show

signs of a malignancy. Mr Brant underwent an oesophagectomy and splenectomy to

remove the malignancy. However when this was later examined, no evidence of a

carcinoma could be found. Investigation attributed the error to a contaminated biopsy

forcep that had been used on a previous patient, and upon which a malignant

“fragment” remained (personal communication).

In 2002, staff at Middlesbrough General Hospital unknowingly reused surgical

instruments that had been previously used on a patient diagnosed with CJD69,70.

Instruments used on patients thought to be at-risk of CJD should be quarantined until

the diagnosis is confirmed but this did not happen. Investigation determined that 34

patients might be at risk of cross contamination, having had a similar procedure to

the original patient7. This figure was subsequently reduced to 24, but was expected

to fall further: “it appears that the number of patients who may be at any real risk of

exposure – albeit a very small risk – is likely to be less than the 24 identified”70.

57 respondents considered that there was a risk of device failure if SUDs were

reused. Of these, 30 were nurses, 15 were anaesthetists, seven were ODPs and four

were theatre managers. When assessed against the total number within each

occupation group, anaesthetists (45%) were least likely to foresee device failure as a

risk or danger associated with SUD reuse. Nurses and ODPs (both 73%) were most

concerned, followed by theatre managers (67%). Explanations ranged from complex

7 At the time of the incident, Middlesbrough General Hospital did not have a

procedure for tracking surgical instruments, or linking their usage to individual

patients70.

52

statements, such as “the integrity of the device may be compromised and it may not

perform as expected or could fail whiles being used” (ID 27 / Nurse) to

straightforward comments suggesting “device failure” (ID 102 / Anaesthetist) and

“breakage” (ID 108 / Anaesthetist).

Device failures caused by reprocessing have included catheters snapping and

laryngoscope light-beams being smashed. Collignon et al61 described the physical

deterioration of reprocessed single use ablation catheters, whilst Heeg et al68

suggested that mechanical failure is likely to occur because SUDs are “more delicate

and physically complex than reusable devices”.

23 respondents considered a danger related to the reuse of SUDs was the inability to

adequately clean the devices. Of these, 13 were nurses, six were anaesthetists, four

were theatre managers and three were ODPs. However, when compared to the total

number within the occupational group that participated in the research, 32% of

nurses were concerned about the inability to clean SUDs, followed by 27% of ODPs,

18% of anaesthetists and 17% of theatre managers. Respondents described how

SUDs “can’t be sterilised and cleaned adequately” (ID 38 / Nurse) and how there are

“quality control issues on re-sterilisation” (ID 80 / Anaesthetist).

SUDs are not designed to be able to withstand reprocessing, and as such, cannot be

“successfully decontaminated using current standards for reprocessing”68. For

example, devices are manufactured from materials such as plastics that are heat

sensitive, or are intricately designed so that they cannot be ‘flushed’ through or

washed out (for example, the use of lumens). As a consequence, “residual

biological material may contain viruses or other infectious

agents”61: this cardiac ablation catheter is contaminated

with blood residue.

Only 14 respondents commented on the ethics of care and safety leading from reuse

of SUDs. Of these, eight were nurses, three were anaesthetists, two were theatre

managers and one was an ODP. However, a different pattern of concern can be

seen when comparing these percentages with the total number of each occupational

group that participated in the survey. 33% of theatre managers and 20% of nurses

were concerned about the ethics of care and safety leading from the reuse of SUDs.

53

Just 9% of anaesthetists and ODPs mentioned how reuse of SUDs might

compromise safety and ethics. Respondents described how SUD reuse

“compromise[s the] safety of patient[s] and staff” (ID 37 / Nurse), and “giv[es] a less

than quality service to the second and subsequent patients who did not have the

instrument first” (ID 48 / Theatre Manager).

The reuse of SUDs places both patients and staff at risk, and is also ethically

contentious in that it compromises the quality of care received by the patient55,71.

Consequently, the practice has been described as “medical experimentation without

benefit, written consent – or even patient knowledge”71. What makes SUD reuse

even more ethically controversial, is that most patients will be unaware of the

practice, and will give their consent to medical treatment without knowing all the facts

about the care that they will receive.

SUDs are designed to be used once and be discarded. Reuse of a SUD therefore

invalidates the manufacturer’s warranty. Only 11 respondents recognized that reuse

rendered the guarantee void. Of these, eight were nurses, and three were

anaesthetists. However, they represented just 20% and 9% of all nurses and

anaesthetists participating in the survey.

Reuse of SUDs can place both patients and staff in danger of iatrogenic transmission

of disease, and for the patient, can result in harm caused by breakage or failure of

the device in use. Since reuse invalidates the manufacturer’s warranty, any litigation

costs arising from device failure will be met by the hospital and the staff members

concerned.

11 respondents referred to the risk of litigation as a consequence of reusing SUDs.

Of these, six were nurses, three were anaesthetists and two were ODPs. They

represented 15%, 9% and 18% of all nurses, anaesthetists and ODPs participating in

the survey.

Respondents were asked if they were aware of any Hospital or Trust guidelines or

policies relating to the reuse of SUDs (table 14).

74% of respondents reported that they were aware of hospital guidelines detailing the

use of SUDs. These guidelines could be broken down into 3 main categories which

accounted for 92% of responses: reuse of any kind must not occur, specific low risk

54

items can be reused, and manufacturers’ guidelines are followed. Two further

categories – lack of awareness and other - accounted for the remaining 8% of

responses.

Table 14: Awareness and understanding of SUDs guidance

N %

Reuse of any kind must not occur 30 57

Follow manufacturers guidance on reuse 13 25

Specific low risk items reused 5 10

Unaware of policy 2 4

Other 2 4

Total 52 100

Surprisingly, a few respondents who earlier in the survey had reported the reuse of

certain SUDs, now claimed that SUDs were not reused at their hospital. One

anaesthetist commented, “the risk management group have stated that all devices

labelled single use should be single use and that we should move to a position where

most items in contact with the patient are single use” (ID 81). However, despite this

statement, the respondent had earlier reported the current reuse of bougies,

laryngoscope blades, LMAs, breathing circuits, recovery T pieces, doppler probes,

facemasks and most surgical instruments. Devices reported as being reused by other

respondents included laser probes used in glaucoma surgery, compression

garments, sampling lines and angle pieces.

Nevertheless, the majority of respondents were clear that “no SUD is to be reused

under any circumstance” (ID 13 / Nurse). Despite respondents explaining that no

reuse of SUDs should occur, and paraphrasing the guidance issued by the MDA6,

only one respondent referred to the “national guidelines” (ID 106 / Anaesthetist). This

may suggest that greater awareness of the MDA’s6 guidelines is required. This lack

of awareness was emphasised by the comments made by three nurse respondents.

They described how they were either not aware of the written policy, or had not read

it recently, but simply followed the practice of others and did not reuse SUDs.

Certain devices were perceived as only having a low risk of cross contamination,

infection or failure if reused. These were breathing circuits (if protected by the

55

appropriate breathing filter) and compression garments. For example, one nurse

described how compression garments “are disposed of if they come into contact with

the patient’s skin” (ID 21), whilst an anaesthetist commented that “gas sampling lines

[are] changed only when damaged or contaminate[d] but are always used behind a

breathing filter” (ID 107). However, in both of these cases, the contaminant may be

invisible to the human eye.

55% of respondents were aware of Trust guidelines. The majority of these

respondents described how Trust guidelines stated that reuse of SUDs must not

occur (Table 15).

Table 15: Awareness of Trust policies on SUDs

Trust policy consistently matches the policies of individual hospitals, as described

above. However, in many cases, the hospitals and the Trust are one organisation.

Conclusion

Despite the guidelines issued by the MDA6 in 2000, which effectively ‘banned’ the

reuse of SUDs, this survey has demonstrated that the practice of reusing SUDs still

exists. Whilst we are unable to determine the extent of reuse, due to our sampling

difficulties, our data demonstrates that the practice continues.

There is already substantial concern about the risk of hospital - or healthcare -

acquired infections, affecting 95,000 people a year, and leading to approximately

5,000 fatalities72. The reuse of SUDs poses an additional threat to patient safety

through cross infection, contamination or device malfunction.

N %

Reuse of any kind must not occur 29 59

Follow manufacturers guidance on reuse 13 27

Specific low risk items reused 3 6

Unaware of policy/policy in development 2 4

Follow other guidelines for reuse 2 4

Total 49 100

56

This survey has shown that reuse of SUDs is likely to occur because of:

Confusion about what single use means.

A perceived lack of risk associated with reuse.

The lack of other available equipment.

The cost of replacing each SUD with a new SUD.

Unrealistic expectations about disposal of certain devices after just one

use.

While there are strong suggestions in the data that reuse is most likely to occur in

large, high-throughput hospitals, the sampling problems mean that this cannot be

stated as a firm conclusion. This is a particularly unfortunate consequence of the

abandonment of the original design. Similarly, there are insufficient data to explore

the possibility of other associations and, in particular, of regional variations in the

practice. We suggest that this continues to be an area that warrants detailed

examination.

Further educational and regulatory efforts to discourage reuse are clearly desirable,

but it is questionable how effective these can be without more fundamental

agreement on what actually constitutes reuse and to what devices this classification

should be applied. An enhanced communication programme needs to rest on

greater clarity about what is to be communicated.

57

Part Three: The Interviews

All fieldwork for the interview phase was conducted by Dr Rowley, under the

supervision of Professor Dingwall. Professor Currie assisted with a small number of

interviews. Dr Sharples and Dr Norris carried out an ergonomic analysis of

anaesthetic devices kindly supplied by leading manufacturers (see Appendix six),

and Professor Whynes performed a formal cost-benefit analysis of the available

financial data, which can be found towards the end of the main body of the report.

A purposive sample of hospitals was constructed for the interview phase,

incorporating some where individual staff members had responded to the survey and

a parallel, but not strictly matched, group where staff did not. The purposive sample

covered a range of hospital characteristics (location (urban/rural), geography

(Strategic Health Authorities), hospital size (bed numbers) and Healthcare

Commission star rating). Staff from 55 hospitals reported reuse of SUDs during the

earlier survey: 5 of these were included in the sample (table 16).

Table 16: Trusts responding to the survey and included in the interview sample

Hospital ID Trust SHA Star Rating

2003-4

Star Rating

2004-05

No. Beds

1 A A 1 3 ↑ 503

2 B A 3 3 ↔ 1300

3 C B 0 0 ↔ 1140

4 D B 2 2 ↔ 660

5 F A 3 3 ↔ 1000

Table 17 lists the devices that staff reported as being reused:

Table 17: Reuse reported by survey respondents

Hospital ID Reused SUDs

1 Facemasks, Anaesthetic Circuits, Compression Garments

2 Facemasks, Anaesthetic Circuits, Compression Garments, Gas

Sampling Lines

3 Pressure Infusor Bags, Intubating Bougies

4 Anaesthetic Circuits, Intubating Bougies, Non-Sterile Gloves

5 Facemasks, Anaesthetic Circuits

58

An additional eight hospitals, whose staff had not responded to the survey, were

included in the sample (Table 18). Five of these were located in the same Strategic

Health Authorities (SHA), whilst the remaining three were from a third SHA selected

for comparative purposes (socio-economic differences and influence of industrial

workers in urban/rural region).

Table 18: Additional Trusts selected for interview sample

Hospital ID Trust SHA Star Rating

2003-4

Star Rating

2004-05

No. Beds

6 E B 2 2 ↔ 450

7 G A 3 3 ↔ 635

8 A A 1 3 ↑ 108

9 A A 1 3 ↑ 690

10 A A 1 3 ↑ 212

11 H C 2 2 ↔ 535

12 H C 2 2 ↔ 530

13 H C 2 2 ↔ 67

In total, 13 hospitals spread across 8 NHS Trusts and 3 SHAs were invited to

participate in the interview phase of the study. As with the survey, NHS research

governance presented serious obstacles to the efficient, effective and timely conduct

of the research. These are detailed in Appendix five. However, MREC and R&D

approvals were eventually gained for all participating Trusts.

In each hospital, the Theatre Manager and Clinical Director of Anaesthesia were

invited to participate in an interview. Each was asked to recruit one ODP, who would

also be invited to participate. These individuals were selected as they are likely to be

involved in the practice of using single use devices, or are directly responsible for the

management of the theatre/anaesthetic room environment and for stocks of

equipment. Given the lack of success at recruiting surgeons to participate in the

earlier survey, we considered it more cost-effective to pursue the recruitment of

anaesthetists, theatre managers and ODPs. However, this has resulted in the study

being more focused on anaesthetic devices than had been planned.

59

In total, 60 invitation letters and emails were sent to 37 individuals, resulting in 23

interviews 8. The final sample (23/37) therefore reflected a response rate of 62%.

The sample comprised one sterilisation manager (SM), eight ODPs, nine theatre

managers (TM) and five clinical directors of anaesthesia (CDA) (

Table 19). The lower number of CDAs recruited was due to a number of job

vacancies and the nature of the role, where a clinical director may work across

multiple sites within a Trust. Where ODPs were recruited via theatre managers or

clinical directors of anaesthesia, only one was ever available for interview.

Table 19: Sample Composition

Hospital ID Theatre

Manager

Clinical

Director of

Anaesthesia

ODP Sterilisation

Manager

1 No No No N/A

2 Yes Yes Yes N/A

3 Yes No Yes N/A

4 Yes Yes Yes N/A

5 Yes Yes No N/A

6 Yes Yes Yes Yes

7 Yes Yes Yes N/A

8 Yes No No N/A

9 Yes No Yes N/A

10 N/A N/A N/A N/A

11 Yes No Yes N/A

12 No No No N/A

13 No No Yes N/A

At no stage is any individual or Trust identified by name. Direct quotations are identified by hospital number (as in Table 19) and the individual’s occupational role: for example, ‘1CDA’ would be the

clinical director of anaesthesia from hospital 1.

8 The final sample contained 12 hospitals. Hospital 10 was omitted as the Surgical

Services Manager failed to sign the R&D form, despite repeated requests. After the

fourth attempt, it was considered uneconomic to pursue the signature further.

60

Interviews built on the scientific background and survey findings and were designed

to collect data on:

1. Rationales for the reuse of specific medical devices in specific settings, where

this is occurring, or for avoiding reuse, where this is not;

2. Cost differences between single use and equivalent re-usable devices; and

3. Procedures employed for decontamination and their associated costs (where

reuse was reported).

Respondents were sent the following list of questions and advised that, whilst the

interviews would cover the topics outlined, they could also include issues that

respondents wanted to raise and discuss with the research team.

1. What is the department’s / hospital’s policy relating to the use and reuse of single

use devices?

2. How many single use devices are used in the department each year?

3. How many single use devices are purchased by your department each year?

4. What are the cost differences between similar single use and reprocessable

devices? (For example, a laryngeal mask is available in both a single use and

reusable form.) Please provide examples of devices and their costs.

5. What are the cost differences between re-using single use devices and

purchasing new equipment? Please provide some examples, and include all

costs associated with the device lifecycle, as detailed in the chart below.

61

6. What procedures are undertaken to return a single use device to a state where it

can be reused?

a. What are the costs involved in these procedures?

b. What is the time delay involved in these procedures?

7. What are the indemnity costs involved regarding the use and reuse of single use

devices?

8. Are the lifecycle and indemnity costs associated with re-using single use devices

included within your department’s calculations/budgeting decisions? For

example, are these lifecycle costs factored into the decision to use single use

devices verses reprocessable devices or to purchase new single use devices

verses re-using single use devices? If they are not, which department picks up

the cost of the reprocessing?

9. How is the balance of likely adverse effect against cost & performance pressures

assessed and what is the response?

We anticipated that two interviewing formats would be followed:

• Task-based interviews with Theatre Managers and Clinical Directors of

Anaesthesia, where they would be asked to explain their rationales for the

local practice of using (and/or re-using) single use devices and to relate

these to current national and local policies and guidelines. Theatre Managers

would also be asked about the number of single use devices purchased and

the number of single use devices used.

• Situational interviews, a process that incorporates both observation and

interview, would be carried out with ODPs. This format built on the

experience of Dingwall and colleagues73 when interviewing child protection

workers about their work as documented by their own selected case files.

This allowed the interview responses to be disciplined by reference to

decisions actually made rather than being coloured by knowledge of official

policies or socially desirable responses. As such, it represented a better

proxy for observational data than traditional interviewing techniques. ODPs

would be interviewed in their own workspaces and asked to talk through the

local stocks of devices and the circumstances in which they are used.

However, in practice, all the interviews tended to combine these formats. Formal

question and answer exchanges were used in combination with more informal,

situational accounts and demonstrations of devices, cost data and decision-making

models. Moreover, whilst interviews in the workplace were possible in a minority of

62

cases, the majority of the interviews took place in offices or meeting rooms within the

theatre department but away from the clinical (sterile) areas. On two occasions

however, Dr Rowley was required to ‘gown up’ in order to enter the clinical area

where the interview took place.

All interviews were semi-structured and presented comparable questions to all

participants. This format allowed the research team space to adapt the interview and

elicit further responses from participants in the light of local circumstances7. All

interviews bar one were audio recorded, with the informants’ consent, using digital

recording equipment. Once transcriptions were completed, data analysis began.

Bryman and Burgess74 describe how, “data are collected and after a general

reflection on ‘issues of concern’ categories which fit the data are generated”.

Similarly, ten Have75 suggested, “analytic induction is a technique used primarily by

qualitative researchers to access commonalities across a number of cases and

thereby clarify empirical categories and the concepts that are exemplified by the

cases included in a category”. Consequently, data analysis was driven and

“developed from phenomena which are in various ways evidenced in the data”76.

Results

The widespread introduction of single use devices followed awareness that

sterilisation and decontamination processes were ineffective at removing all microbial

and proteinaceous materials from surgical and anaesthetic instruments41,79. Evidence

of iatrogenic transmission of Creuztfeld Jacob Disease (CJD) first emerged in the

1950s, when concerns were mooted about the possibility that contaminated surgical

instruments could infect patients78. These were reiterated in the 1970s following

iatrogenic cross infection stemming from the use of cadaveric corneas during

transplantation79. However, it was not until the iatrogenic transmission of variant CJD

(vCJD) from one neurosurgery patient to another that alarm was raised about the

medically induced transmission of vCJD. Then, in 1998, prion protein was discovered

in the lymphatic tissue (appendix) of a patient who subsequently developed vCJD80.

When asked to account for the introduction of single use devices into anaesthesia 9,

respondents were clear about the role of the threat of vCJD transmission, and their

9 As noted earlier, the absence of any surgeons from the sample means we can only

examine the use of single use devices in anaesthesia. This does not imply that there

are no problems with the use of SUDs by surgeons.

63

increased awareness that prions remained on stainless steel surgical instruments

despite the decontamination process:

Well I think what prompted all this to happen was when they brought in single

use tonsillectomy instruments and things. And there was this big like ‘oh my

goodness’ you know and then we’re thinking, ‘well we’re working in exactly

the same area, why aren’t we doing anything, we’re just washing ours under

the tap and they’re having to spend millions on single use instruments’

(3ODP)

With new variant CJD coming to the fore and the risk of transmission through

tonsil tissue and any tube that’s going to pass them, hence that was mainly

the main spur for us moving to single use bougies, laryngoscope blades

(3TM)

Disposable laryngoscope blades are used in ENT cases due to risk of vCJD

and the presence of prions in tonsil region (4CDA)

Given the emphasis that has been placed on the threat of iatrogenic transmission of

vCJD, and other transmissible spongiform encephalopathies (TSEs), it is generally

agreed amongst clinicians that their “awareness of risk has become much higher

than it used to be” (2TM). They disagreed, however, about how ‘real’ or significant

the threat of iatrogenic vCJD, or any other disease, may actually be. Whilst one

anaesthetist considered that “clearly there’s a risk of transmission of diseases we

know about and I’m sure some we don’t yet know about, so single use would appear

to be the way to go” (2CDA), others questioned whether the extent of the actual risk

had been exaggerated:

I mean, we don’t know what size the risk was, but presumably there was a

small measurable risk there that is no longer there (6CDA)

Well before they went to single use was there ever a cross infection risk? And

the answer is no, because I don’t think there’s ever been a case of it, not

even for something like herpes or something like that. I don’t think that’s ever

been reported from one patient to another because they used to go and get

sterilised, sent back and that was it. So it wasn’t that they weren’t clean, we

used to clean them thoroughly after use, dry them and put them back….it’s

64

just creating more money for these companies that are jumping onto the band

wagon saying that something should be single use (4TM)

A number of authors have argued that there is “no firm evidence to indicate that the

reuse of SUDs ha[s] caused a health hazard”81,82. However, others have disagreed,

pointing to the long incubation period of prion related diseases61, and arguing that the

long term safety and efficacy of reuse is still unknown66. More recently, Walsh83 has

suggested that, if the risk from airway devices such as breathing circuits and

laryngeal masks had been significant, the consequences would have been visible by

now. Respondents frequently compared the ‘actual’ threat of cross contamination

linked with medical devices and everyday items, like china or cutlery:

If you’re eating with knives and forks in public restaurants that aren’t sort of

autoclaved in any way but washed as they are, you don’t see them, you’re

probably just at risk of getting anything as if you put a laryngoscope blade into

somebody’s mouth (5CDA)

It’s like you eat off a plate that somebody else has eaten off, it’s been washed

you don’t think “I need a new plate…” (7CDA)

Whilst discussing the influence that being risk aware had on their practice and use of

disposable and reusable equipment, respondents drew distinctions between the

know and unknown risk status of patients. For example:

Disposable laryngoscope blades are used in resuscitation, as the patient’s

disease status and risk level is unknown (4CDA)

Patients that generally aren’t screened come ‘off the road’, shall we say, like

our emergency theatre and our trauma theatre, and we change the

anaesthetic circuits at the end of each list. But those that are in a controlled

environment where we know their pathology or whatever else you’d like to

call it, we change at the end of each week (4TM)

Whilst respondents felt able to balance the risk of the known against the unknown,

there are dangers in relying too heavily on apparent evidence of a patient’s risk

status, as in the Middlesbrough case, where a CJD diagnosis was apparently

unanticipated. Instead, the instruments underwent a routine sterilisation cycle (known

65

to be ineffective in the decontamination of TSE proteins) and were used on a further

24 patients. Clinicians considered the risk status of patient A (diagnosed post-

operatively with CJD) to be known (initial diagnosis of dementia) but, with hindsight,

the patient’s risk status was unknown. During an interview for this study, an ODP

noted how a system relying on known and unknown risk status was inherently

flawed:

We do have disposables, we tend to keep those for infected cases where a

patient is known to be Hep B or you know. You never know, everybody that

walks into theatre should be treated the same because you don’t know who’s

got Hep B and who hasn’t (11ODP)

A further distinction between safety and exposure to prions was made by an ODP

who argued that exposure to possible cross contamination from a reusable device

was less of a consideration in an emergency situation:

If you’ve got someone that’s about to die, then sod the prions, you just use

the reusable (3ODP)

This ODP considered that when the small risk of keeping a patient alive by using a

reusable device, which might have been exposed to prions, was compared to the

probable fatality if the equipment were not used, the exposure was acceptable. This

example, as well as a similar case discussed later, was informally discussed with a

contact at the MHRA, who considered that the account provided by the ODP

demonstrated that an adequate risk analysis had been performed.

As these quotes illustrate, clinicians are concerned about the threats of exposure to

cross contamination, but, at the same time, are also aware that the risks might have

been overestimated. Those questioning whether the risk of cross contamination has

been exaggerated pointed to the discrepancy between the guidance issued about

the risk of cross infection with anaesthetic devices and that issued about surgical

instruments, and also to the inconsistency between different anaesthetic devices.

In 2001, the Department of Health published a circular directing that all

instrumentation used in tonsillectomy (lymphatic tissue) surgery must be single use,

following advice from the Spongiform Encephalopathy Advisory Committee (SEAC)

that there was a theoretical risk of transmission of vCJD22,84. Almost simultaneously,

66

the AAGBI issued guidance28, which suggested that anaesthetists should use single

use laryngoscope blades due to the proximity of the tonsils. While the Department of

Health guidance about the utilisation of single use diathermy equipment during

tonsillectomy was later withdrawn, following an increase in adverse incidents (post-

operative bleeding) and at least one patient fatality, the guidance to anaesthetists

remains in force. There is however some confusion about this. Whilst the AAGBI’s

Infection Control guidelines are still in place, advising the use of single use

laryngoscopes, documents from the Royal College of Anaesthetists imply that this

guidance has been withdrawn and encourage anaesthetists to use single use

devices only if they consider them to offer optimum practice85.

In contrasting the infection risks from facemasks and intubating devices, the

suggestion that the risks of medical devices and cutlery are similar, was repeated.

However, one ODP cautioned about devices inserted into the larynx:

I think things like anaesthetic facemasks I don’t, you know I’d be quite happy

to have one that had been washed thoroughly under a tap. You know, you go

into a restaurant and you have cutlery that hasn’t been through an autoclave

don’t you? But I wouldn’t want to use a knife that someone had shoved right

down into their larynx (3ODP)

The AAGBI28 recommends that anaesthetists use single use laryngoscope blades

because of the potential for cross infection, but similar guidance has not been issued

about single use laryngeal masks and bougies. As figure 4 demonstrates, both are

inserted into the same area as the laryngoscope (the larynx) and will carry ‘risky’

protein and biofilm past the tonsils83.

67

Figure 4: Positioning of laryngeal mask.

Source:

http://health.allrefer.com/health/epiglottitis-throat-anatomy.html

Source: www.brandianestesia.it/Images/LMA-ins.jpg

The inconsistency in advice was noted by an anaesthetist:

My personal opinion doesn’t matter because there is national guidance on

this, but my own personal opinion is that if you only had money for one thing,

continue to wash laryngoscope blades or you have the money to have

disposable laryngeal masks, I would go disposable rather than to

autoclavable laryngeal masks. And yet the dictates of contamination are that

that fits the bill but that is against national guidelines therefore it’s the other

way round ...If I had a choice between having a laryngeal mask that had been

shoved down forty other people or a brand new one I’d want a brand new one

put down me and then have it thrown away, because if you are talking

seriously about infection risks and protein contamination and you know,

variant CJD, then laryngeal masks are going to be prime bits of kit that could

potentially transmit it. And they are autoclaved, but as you well know,

autoclaving does not get rid of this specific problem (5CDA)

The discrepancy between guidance to anaesthetists and to surgeons was

emphasised by one ODP, who compared their inability to use a reusable set of

stainless steel Magill forceps, which, although used to assist intubation, are unlikely

to come into direct contact with any lymphatic tissue, with a surgeon’s ability to

undertake appendectomy and neurosurgery without using single use equipment,

despite the greater likelihood of exposure to prions:

68

Magill’s forceps: you could use reusable and

sterilise them like you do surgical instruments

but it’s the prion thing. But they’re still cutting

out appendix and you know that’s a prion risk of

doing neurosurgery without single use

instruments (3ODP)

The ODP’s reaction is understandable; Magill forceps are non-invasive devices, yet

are single use. In comparison, surgeons are able to reuse instruments which come

into close contact with areas of the body where prions are likely to occur.

It would seem desirable that more consistent and principled guidance should be

developed both within and between specialties working in operating areas.

The survey findings, of considerable confusion about the definition of the term ‘single

use’, were replicated in the qualitative interviews.

As noted previously, the official UK definition is set out by the MHRA6:

Single use - the medical device is intended to be used on an individual patient

during a single procedure and then discarded. It is not intended to be

reprocessed and used on another patient. The labelling identifies the device

as disposable and not intended to be reprocessed and used again.

We have argued that this definition is confusing and does not effectively distinguish

between a single episode of use and single patient use10.

• Some single use devices, such as stapling guns used in a bowel anastomosis

procedure, can only be used on a single episode. They are pre-loaded with a

number of staples, but once removed from the rectum cannot be re-loaded

and reinserted (single episode of use)

• Some single use devices, such as laryngoscopes are used to assist the

intubation and extubation of the patient, and may be used on more than one 10 The MHRA definition of ‘single use’ was altered in DB2006(04). We discuss this

alteration and what consequences it has for our argument in footnote 4 (page 29).

69

occasion in each of these episodes. Flowtron boots are anti DVT devices

which the patient wears for an extended period of time throughout their

hospital stay (single patient use).

Both types of event are covered by the same MHRA definition, which considers

reuse to have occurred only if the device has undergone some form of reprocessing

between each episode of use.

Our interviews confirmed the confusion about the difference between single use and

single patient use devices. In one Trust, for example, different interpretations were

held by the sterilisation manager and the theatre manager:

It’s a classic: the differences between single use and single patient use.

Really, it’s all single use in my view (6SM)

It depends on how the packaging is labelled; if it’s for single patient use or

single sort of anaesthetic gear could be used for a session, for a day and the

disposed of. As I say, it depends on what the items are (6TM)

However, as we show later when discussing device labelling, current provision is

inconsistent, notwithstanding EU CEN directives86. Moreover, our ergonomic analysis

(Appendix six) found at least one device where the packaging was labelled single

use, but the device itself was labelled single patient use (Figure 5).

Figure 5: Inconsistent labelling

Unlike the sterilisation manager quoted above, participants who were working in

theatres tended to prefer the definition that referred to single patient use:

SINGLE PATIENT USE

70

If it’s single use …..well to me, a single use means single patient use so they

would just dispose of it after the single patient use (8TM)

Respondents were suspicious of the basis on which devices were labelled as single

use. This was thought to be more a question of quality – that the manufacturer could

not guarantee that they would be fit for use on a second occasion or would withstand

reprocessing - than of the assessed risk of cross infection or contamination:

I think with the Flowtron boots that’s, it’s not always necessarily easy to see

what the issue is because that’s, it’s single patient use rather than single use,

and it’s that confusion isn’t it? There’s a single patient use and a single use

so you usually when you say single use it means that the company won’t,

obviously the company won’t guarantee that to be used again. Whereas the

single patient use what they’re saying is it’s the infection control or cross

contamination or whatever that’s the issue (5TM)

Our survey data demonstrated confusion over the lifespan of breathing circuits, and

we have previously discussed the history of this issue. The same confusion emerged

in the interviews about whether single use status was mainly intended to address

risks of cross contamination or infection or device malfunction.

Whilst some breathing circuits are labelled as single use, the instructions provided

with others state that the device can be used for seven days (see figure 10). We

outlined earlier in the report how manufacturers will guarantee the use of breathing

circuits for seven days if they are protected with a single use breathing filter, which

must be changed for each patient. However, one participant, who was generally

against the use of single use devices, considered this practice to be misleading and

diverged from the true meaning of single use:

We’ve got round the breathing circuit, single use, put it on, have a clean filter,

but we don’t actually change the breathing circuit except every week or every

X days when we decide. We sort of cheat, that isn’t single use. Yes it is

because we only put it on once (7CDA)

At the centre of this definition is a rationale that concentrates upon relative risk. By

using a filter with each patient, the risk of cross contamination is perceived to be

miniscule32 and so the apparent reuse of breathing circuits is justified. The filter

71

precludes any infective or hazardous particles entering the patient’s respiratory tract

from the anaesthetic gases32,33. However, when patients’ risk status is unknown, the

manner in which breathing circuits are used and replaced appears to change:

The manufacturer recommends that the circuits are changed weekly.

However, when used in our emergency or resus’ theatres, they suggest that

we should change them at the end of each day, due to the high-risk status of

patients (4CDA)

As might be expected in the current climate, the rationale for the use and limited

reuse of breathing circuits was governed by cost, and the need to balance

expenditure and risk:

I’ve not worked anywhere where a single use breathing circuit is used once

and thrown away, it just couldn’t be done, the Health Service would’ve gone

out of business years ago (4TM)

An average cost of a single use breathing circuit is approximately £8.00. By using it

in a manner meeting the definition of ‘limited reuse’, considerable financial savings

can be made. For example, one circuit used in a limited reuse fashion (i.e. over

seven days), with an average of five operations per day, 35 operations per week,

would save in excess of £280 in each theatre per week. Over a year this equates to

approximately £14,500 per theatre 11.

The management of the seven-day time limit for the use of breathing circuits

highlighted a potential system weakness. The following quotation illustrates how a

badly designed system could harm patient safety:

11 All pricing figures are taken from the NHS Purchasing and Supply Agency’s October 2004 catalogue.

72

Respondent: All the circuits we have are all date stamped as they’re put onto the

machines so in seven days’ time they’ll be changed and thrown away.

Interviewer: Is there a person whose sole responsibility it is to change them or is it

whoever sees it changes it?

Respondent: It’s the anaesthetic staff who change it. Sometimes it’s the night staff,

sometimes it’s the weekend staff.

Interviewer: Is there ever an opportunity where somebody might forget and it gets

left?

Respondent: It’s always possible. That wouldn’t be intentionally though (3TM)

Without an explicit procedure for changing the circuits, patient safety may be placed

in jeopardy. In the absence of a procedure, it is not clear whose responsibility it

would be to change the circuit. The circuit may not be replaced if an individual is on

leave, if someone forgets or if no one notices that the stamp is out of date.

If microbiological evidence suggests that breathing circuits can withstand limited

reuse, then any wording or labelling implying that they are single use devices should

be removed. Clinicians seem to need better education about the status of ‘limited

reuse’ and to develop appropriate Standard Operating Procedures to ensure that this

is monitored and enforced. However, we are also concerned that, in their present

form, the labelling and instructions concerning limited reuse are problematic.

We are not alone in voicing our concerns about the confusing nature of single use

device labelling or the use of the single use logo. The following table documents 14

definitions of ‘single use’ found during the study.

73

Table 20: Popular definitions of 'single use'

Named patient87

Single patient (X number of days) 87

Single patient (X number of separate episodes) 87

Single episode87

Single patient87

Single use87,88,6SM

Disposable89,90,91

Single patient, single procedure89

Suitable for one episode of use only92

A single use medical device is intended to be used on an individual patient

during a single procedure and then discarded65

Single use disposable93, 6ODP

Throw-away kit90

Designed to be used only once60

Reusable disposable www.ce-mark.com

Single use devices should be identified by the following symbol, which can replace

any wording to the same effect86,95.

Figure 6: Single Use Symbol.

The symbol, mandated in European Union guidelines86 and harmonised in the

Medical Device Directive4 and by ISO96, is considered to be reasonably intuitive (see

Appendix six for further discussion). However, the symbol in figure 6 can be

supplemented by the following three descriptive statements:

74

• DO NOT REUSE

Synonyms for this are:

• Single-use only

• Use only once

The latest draft EN standards86 describe the single use logo as “well

understood…and deemed to be suitable without need for further explanation” (p.8).

Some respondents agreed:

Products are clearly marked single use. So it does what it says on the tin!

(3TM)

However, others were concerned that the labelling was not as clear as it might be.

During the research, we were contacted by one Trust which had been reusing single

use laryngoscopes within their theatre department. While staff from this Trust had

participated in the survey, they did not report the reuse of these devices and were

not selected for the interview phase 12. However, representatives approached us

after our presentation at the AfPP Congress 2005 to share their work on the

consequences of reuse. The following photographs (Figure 7) of a reused and

reprocessed single use laryngoscope, show the failure of decontamination methods

to remove all traces of blood and protein.

12 Devices reported as reused: gas sampling lines, C02 airway adapters, paediatric

breathing circuits, adult breathing circuits, anaesthetic facemasks and LMAs.

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Figure 7: Contaminated single use laryngoscope blade

Source: Rowley, personal communication 2006

It is not known how many times this blade had been reused and how many patients

may have been put at risk. However, as the images demonstrate, residual debris

(most likely to be blood and lymphatic tissue) can be seen on the blade. The reuse of

laryngoscope blades reported by this Trust was explained in the following terms:

We are using both reusable and single use versions and there is staff

confusion and lack of knowledge of the single use symbol and its implications.

This reported confusion and lack of knowledge of the SUDs logo endorses the recent

views of the MHRA’s committee for the safety of devices93, who described the

symbol as “misunderstood and confusing”. One anaesthetist explained:

Single use labelling is not obvious enough – for example, single use

laryngoscope blades look like reusable blades to the untrained eye. The

result of this is that reusable blades get thrown away, as they are mistaken

for single use devices. The solution is to colour code devices, as the single

use status needs to be visual and noticeable (4CDA)

SINGLE PATIENT USE

76

Colour coding single use devices to distinguish them from reusable equivalents was

suggested by other participants. If established, this would follow the precedent set by

the national colour coding of syringes and drug ampoules59,97,98. Indeed, some

hospitals had begun to source colour coded devices in a bid to differentiate single

use and reusable equipment:

The laryngoscope blades and things like that, if you held a reusable and

single use one up, you can hardly tell. What I’ve done with ours…is get a

yellow marking on it (3ODP)

Recently, Intavent Orthofix have offered colour coded laryngeal masks, to mark the

departments in which the device is used (Figure 8). Blue caps signify that the mask

should be used only in theatre, for example, and clear caps that it is single use

Figure 8: Intavent Orthofix Laryngeal Mask Colour Coding

Source: Intavent Orthofix.

However, respondents feared that design alterations would lead to price increases.

If you made people change things and make them a different colour all they

would do is they’d make them one or two pence more expensive, it would just

cost us more money (9ODP)

Yet, it was also appreciated that better identification of reusable devices would be

useful:

BLUE

LILAC

GREEN

YELLOW

CLEAR

77

Some quite expensive things have been disposed of by accident, because it

works the other way, because the piece looks single use, they chuck it (6TM)

Des-Côteaux et al99 had to abort their study comparing the costs of reusable and

limited-reuse laparoscopic instruments, as the reprocessable devices were mistaken

for single use and thrown away. Any initial outlay in developing colour coding could

be offset by savings from reducing mistaken disposal. However, manufacturers were

reluctant to ‘spoon feed’ customers (personal communication, Barema meeting,

February 2006). Colour coding was considered likely to offend some customers and

consequently damage sales.

Labels also contained contradictory advice. As one anaesthetist (4CDA) pointed out,

cleaning and disinfecting instructions are provided for the, single use, Eschmann

bougie (Figure 9).

Figure 9: Eschmann bougie: Instructions for Cleaning, Disinfection and Storage

1. Prior to disinfection, thoroughly

wash the introducer in an aqueous

solution of neutral soap, removing

all visible soiling. Abrasion should

be avoided. Rinse with clean water

and dry.

2. Immerse the product in a liquid

disinfectant prior to use according

to the manufacturer’s

recommendations.

3. Devices should be rinsed in sterile

water after treatment with

disinfectant solutions to remove any

residues before use

4. Between uses, the introducer should

be stored in its original container.

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The technical data sheet also described how the bougie could be reused up to five

times following cleaning and disinfection, despite the presence of the SUD logo.

However, as figure 9 demonstrates, the Eschmann bougie itself (top image) does not

have any single use labelling, unlike the Portex single use version (bottom image).

Figure 10: Eschmann (Portex) and Portex bougies

Inconsistencies in labelling also arose from devices changing from reusable to single

use. One theatre manager recalled:

We had a problem in the past, and the problems that we have had is that

when companies have changed from reusables to single use, unless people

are very vigilant. Companies wouldn’t always let us know that it had changed,

and the people in stores weren’t educated enough in their use to know that

the two on the side were single use, and we had a problem with that (9TM)

As this quote suggests, the lack of recognition that the device had changed status

from a reusable to a disposable (or vice versa) was not seen to be a current problem.

However, the incidence of this type of situation points to the need for manufacturers

to keep purchasers and users informed and educated about any alterations. Whilst

Portex 15ch SIZES 6.0-11.0mm SINGLE USE

Eschmann UK 15ch sizes 6.0-11.0mm

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the Chief Medical Officer’s Safety Alert Broadcast System (SABS) and the MHRA

Medical Device Alerts are suitable forums to publish such modifications, the

information does not appear to reach all members of staff who use the devices.

The communication of the idea of ‘limited reuse’ on breathing circuits clearly

presented particular problems, despite the efforts of manufacturers and the PaSA:

I think the only outstanding issue in anaesthetics is possibly the tubing, the,

and the tubing that’s used on the anaesthetic machines is a little bit

complicated because the company sell them on the basis, and they were

marking them single use but they were also putting in the advice on a card

saying that they could be used over so many days providing they were used

with an in-line filter…it’s a little bit ambiguous that because what is limited

reuse, what securities have you got that you change them? (2TM)

Anaesthetic circuits was the big grey area, and we follow the manufacturer

instructions now (7ODP)

Our circuits…have a seven-day life and that’s what the manufacturers say. If

anything comes up with a two and a line through it, then it’s used in that way.

All the circuits we have are all date stamped as they’re put onto the

machines, so in 7 days time, they’ll be changed and thrown away (3TM)

Analysis of two circuits from the manufacturer supplying hospital 3 illustrate the

problems with current labelling practice (figure 11).

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Figure 11: Sample Breathing Circuits (Hospital 3).

These two samples, both manufactured by the same company, contain contradictory

labelling. The instructions for the circuit on the left describe how “the maximum

period of use is 7 days”, whilst the instructions provided with the circuit on the right

contain the single use symbol. Such inconsistencies continue to confuse clinicians

and may jeopardise patient safety.

Respondents were concerned about the potential risk from device packaging. This

included the difficulty of opening some plastic bags quickly in an emergency, and the

threat that pieces of plastic could occlude devices and cause an obstruction:

One thing that we have noticed is that these things come in plastic bags now,

and what can happen is that ODPs can connect up the tube with the

connector, pushing the plastic bag, and as they rip the plastic bag off, a bit of

it gets caught in it, and that can cause obstruction, and there have been

instances of those occurring, probably two or three, and now we have clear

tubes and you would think that you would see it, see the items and that would

maybe improve things, but nevertheless, it’s an additional connection and so

THE MAXIMUM PERIOD OF USE IS 7 DAYS

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is an additional point where things might get into the system and can cause a

problem (6CDA)

The report of the Expert Group on Blocked Anaesthetic Tubing (EGBAT)100, set up

following the death of Tony Clowes, which was linked to an occluded component

within the anaesthetic circuit, identified the storage and wrapping of devices to be an

issue warranting further investigation. EGBAT recommended that devices should not

be opened prior to use and then stored away, where obstruction could occur (as is

believed to have happened in the Clowes case). Nevertheless, as the above

quotation illustrates, our data suggests that potential for occlusion exists even when

devices are opened at the point of use. The recent example of a blocked airway at

Hope Hospital in Salford again demonstrates the dangers associated with

anaesthetic equipment. In a case similar to that of Tony Clowes, a connector used

within the breathing system was occluded by the cap from an IV giving set (Figure

12) (Anon; personal communication, April 2006). Our argument here is not

specifically related to single use devices, but devices in general. Our data suggests

that simple patient safety lessons seem not to have been learnt.

Figure 12: ET connector and IV giving set

Our survey showed that SUDs are reused despite the MDA6 guidelines prohibiting

such practice. Such practice is neither unusual nor contained to the UK. Reuse has

been reported worldwide - a detailed inventory of published reports can be found in

Appendix one. Reused SUDs have included: diathermy pencils, laparoscopic

scissors and forceps, electrophysiological (EP) and cardiac catheters, snares,

sclerosing needles, pacing electrodes, biopsy needles and patient breathing circuits.

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Reuse is considered to be ‘risky’ and to present dangers to the health and safety of

staff and patients. It may result in both physical and physiological harm68. Reports of

such harm include: a reused cardiac catheter that snapped and become lodged in a

patient’s heart, bacterial cross contamination of a reused cardiac catheter which led

to a patient’s death, and a case of iatrogenic Hepatitis B due to the reuse of a

contaminated blood sampling stick71. Many SUDs are delicate and intricate pieces of

equipment68. They have complex design features, such as small lumens or oblique

corners12,101. They are not designed to withstand decontamination and reprocessing

cycles and so may become impaired, damaged or weakened, and thus not function

efficiently, or as designed, on second and subsequent uses.

In addition to the 127 cases of reuse reported in the survey, we received an

additional 15 reports of SUD reuse during our interviews. Three of these

(laryngoscope, bougie and nasal probe) were based on experiences in the

respondents’ previous job. Devices reported as being reused are shown in Table 21.

Table 21: Reused single use devices

Specialist laryngoscope blades (1) Ambu bags (1)

Anaesthetic facemasks (1) Anaesthetic breathing circuits (2)

Blood pressure cuffs (1) Pressure infuser bags (1)

ECG leads (1) Magill forceps (1)

Anti DVT garments (3) Laryngoscope blades (1)

Bougies (1) Nasal probes (1)

The accounts provided by respondents in justifying reuse matched those identified

from our survey data and from other investigations55,64,102,103.

Reuse was overwhelmingly rationalised in terms of perceived costs and lack of risk.

If there were a bottomless pit of money in the NHS then I would be delighted

to use single use devices for everything and throw them away and get a new

one out each time (5CDA)

The perceived costs of SUDs largely reflect the purchasing price of the devices,

which is seen as prohibitive in the current state of NHS finances. Reuse was a cost

saving initiative:

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The previous manager wanted us to reuse anaesthetic theatre masks and it

does say on them single use only. I think his main reason was just cost but if

it says single use it’s single use isn’t it? (13ODP)

What stands out from many of the examples of reuse

reported, both during the interview and survey phases of this

research, is how several of the items that are reused are non

critical, non invasive devices. Moreover, such devices may

previously have been reusable. Anaesthetic theatre masks

would have been run under a tap and/or wiped down by the

ODP and reused on subsequent patients.

Anti DVT garments are another example of SUDs whose labelling has altered.

However, as the following data extracts demonstrate, following their re-labelling,

many hospitals have not had the infrastructure to use the devices effectively outside

of the operating theatre.

We did used to reuse them unless they were contaminated obviously and

now we just leave them on the patient, they go back to the ward, we’ve got

much better systems so they do go back to the orthopaedic ward with them

on. Because initially when we went over to using them as single use, we’d

put them on the patient and they didn’t have pumps up on the ward, so then

we’d be throwing them in the bin and at £19 a pair, when you’ve got a

throughput of 10,000 patients, it’s an awful lot of money (3ODP)

The only things we currently reuse that was designed for single patient use

are anti-embolism devices, DVT prevention stuff. However saying that,

recently recovery have now bought a load of DVT pumps so the, once the

patient is on the table we put the DVT stockings on they then can now go to

recovery and keep them on. So they’re at least not thrown away at the end of

an operation, they can still be used throughout the entire patient’s visit so it’s

not a waste of money (2ODP).

The reuse of such devices is apparently based on an assessment of the cost of

continually replacing the equipment. However, these accounts also imply that there is

little risk involved. These garments are unlikely to come into direct contact with the

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clinical site. They are made of nylon and can be washed/wiped if required. Moreover,

as the quotations show, staff will discard these devices if they are visibly

contaminated.

One Trust had formally risk assessed the contamination/infection threat provided by

anti DVT garments (Flowtron boots), and decided that, if patients wore anti-embolism

(TED) stockings, then reuse could be sanctioned:

The main one for us is the Flowtron boots, it was decided with Infection

Control that we if we put an inner lining to those, to those Flowtron boots that

you know it would still be okay to use them in-between patients and to throw

them away at the end of the week, or at the end of the day (5TM)

This Trust reported that any decisions related to service delivery and medical devices

were based on an assessment of five criteria shown in table 22:

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Table 22: Benefits / Impact of Service Change

Service Delivery/ Business Impact

More patients being treated more quickly

More patients treated

Faster turnaround

LOS (length of stay) reduced

Waiting times reduced

Follow ups reduced

Reduction in unnecessary admissions or

appointments

Reduces DNAs

Innovation in Deployment of Staff

Extending roles

Sharing tasks between

team members

Extending availability of

services

Financial Impact

Contribution to improved financial position

Meets recurrent balance

Meets CIP

Cost avoidance

Increased productivity / reduced costs

Clinical Outcomes

Higher Quality Care

Access to appropriate

care at right time and

place

Intervention – timely

Increase clinical care time

Eliminate unnecessary admissions

Reduce:

1. complaints

2. adverse incidents

3. drug errors

4. infection rates

5. morbidity / mortality

Compliance with national targets (NICE,

NSFs etc)

Staff Experience

Knowledge and skills

framework

Aspirations – opportunity for

professional development

Enhanced roles

Better Morale

‘Managed’ activity

Reduce fire fighting

Recruitment and retention

Implementation Consistent with IWL

Staff involvement (FT+)

Partnerships, teams

Making better use of skills

Contribute working time directive

Patient Experience Better Team work (breaking down barriers) Access (waiting times) Shorter LOS Fewer handoffs Reductions (unnecessary visits, admissions, cancellations) Information and communication Choice Soft issues

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The balance between cost and lack of risk is central to the reuse debate:

We reuse blood pressure cuffs all the time but we do

clean them here in between patients. We have a box

full of ones that have come off and a box of clean ones

so I think that’s good that we do that. Same with ECG

leads, we clean it all before we reuse them. But again

then that has impact, I know it sounds silly but it has a

time impact because it takes time to clean all these

things (13ODP)

Whilst this respondent rationalised the reuse of blood pressure cuffs in terms of

financial savings (Single use approximate cost: £18.00; reusable approximate cost:

£77.0057), the cost of the time taken to ‘clean’ them, diverting staff from other tasks,

must be taken into account. The second respondent’s attempt at balancing the cost

and perceived risk against reuse, involved rejecting the single use nature of the

device:

Blood pressure cuffs they’re supposed to be single use but we don’t count

them as, you know they’re only on the skin. You know, if we reused

everything it would cost a fortune and we’d never have it, because we’d never

be able to replace them (2ODP)

As the last quotation suggests, respondents perceived that, if the device was only

touching the patient’s skin (as with a blood pressure cuff or anti DVT garment), then

there was no reason to use the device on a single occasion only. Other cases of

reuse were defended in similar terms, although these devices did not come into

contact with the patients’ skin:

Items like pressure infusor bags are meant to

be single use but we reuse them. Obviously if

they are contaminated in any way they get

thrown, but we do reuse them…because they

just hold a bag of fluid; they don’t go near the

patient, so we assume we can reuse them

(11ODP)

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As the above illustration shows, pressure infuser bags have a plastic bladder that

acts as an external sleeve, which can be inflated to increase the pressure with which

intravenous fluid is administered to the patient. The device does not need to be

sterile and is unlikely to come into physical contact with the patient. At a

commonsense level, it is easy to understand respondents’ claims that reuse poses

little or no risk. We cannot comment on the validity of this claim but, if it is correct,

there may be an argument for reviewing the classification of such devices.

Taking single use devices straight from their packaging means that clinicians have a

consistent expectation about the device that they are handling. Unlike reusable

devices, which can experience fatigue, general wear and tear, and can become

damaged during use and the reprocessing cycle, single use devices should be fit for

use 100% of the time. Three participants confirmed this, and explained:

You know if you’re going to open a disposable one it’s going to be pukka (4ODP)

Generally speaking, a disposable single use is better than a non-disposable

500 use (11TM)

Well we have diathermy, finger switching diathermy, they cost quite a lot of

money to buy originally, we have to reprocess them and all of the

manufacturers say it will last this long and invariably they don’t…. you know,

you can only lean on people and sort of encourage them towards using these

things single use but it’s their decision. I mean it’s, I’d say diathermy as an

example, a finger switching diathermy you can buy for £1.50. We will buy one

for £100 and if we use it forty times that’s £2.50 a go isn’t it so that’s already

more expensive. Then you add on the cost of cleaning it, the cost of a tip

each time, the cost of reprocessing it, unpacking it and it’s just ridiculous. And

the other thing is because they break down we end up with a situation

whereby the surgeon will plug in a machine and say “it’s not working, it’s not

working, the machine is not working”, and we’ll be like “no, no the machine

was working fine, it’s probably the finger switch.” Well you know they cost

100 quid but chop it in half and throw it in the bin, get another one because

the patient is bleeding. You can’t stand there having a debate….get another

sterile one and have a go. If you have a single use one and you plug it in and

it don’t work you can then go back to the people who make it and you can say

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“right, you know you’re selling pants,” but that’s, that’s how I would do it

personally (9ODP)

However, it should not be assumed that workable equipment was necessarily

perceived as high-quality equipment:

Sometimes they may say that this is a single use device and it’s comparable

to a reusable one but obviously a lot cheaper and it’ll, the actual quality of the

device is not always exactly the same and straight away on usability and

appropriateness it’s sort of you know not used (5TM)

While this should not be read as condemning the quality of all single use devices,

there is a potential problem, for both the health service and the device industry, from

the perception that devices have been designed to minimise NHS costs at the

expense of quality and efficacy. For example:

Sometimes I think you might worry about the strength of things, as things are

often cheaper (6ODP)

Some of the single use items obviously because they’re single use, they’re

cheap and they’re not quite as good a quality as other things (13ODP)

There is pressure on the stores manager to get things as cheap as he can.

We’ve had one or two instances where he’s brought something in and then

everybody just turns round and says “Its pants, I’m not going to use it, its

rubbish, get the old ones back,” and he doesn’t have a choice (9ODP)

A particular concern was the perceived ‘under engineering’ of plastic laryngoscope

blades. Traditionally, metal (stainless-steel) laryngoscope blades have been used by

anaesthetists to assist with the induction of anaesthesia. The patient’s mouth is kept

open whilst an intubating device (such as an endotrachael tube or laryngeal mask) is

inserted. However, whilst satisfying the objective to minimise the risk of cross

infection of TSEs from one patient to another, the quality and suitability for purpose

of the disposable blades has been criticised48,49,105,106. In this study, one anaesthetist

commented:

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Plastic [laryngoscopes]…are in fact under engineered, they’re actually not

up to the job (2CDA)

Others also picked up the notion of unsuitability. Respondents spoke of their

dissatisfaction with the quality of the blades. One anaesthetist recalled how:

The original laryngoscope blades that came out, they were quite cheap…and

the plastic blades were just bloody dangerous, because they just contorted. If

you got a difficult airway and you lifted it, it just bent across (6CDA)

However, it was not only the plastic blades that were criticised for their unsuitability:

similar criticisms were also made of disposable metal blades. One theatre manager

described how their discontent with single use blades had led to them to return to

using non-disposable metal blades. This was despite recognition that reusable

blades present a risk of cross infection due to the inability to remove proteinaceous

material from stainless steel:

Laryngoscope blades, because of the scare with CJD, we were told we had to

use disposable single use laryngoscope blades. So we ordered a load of

them, even though they were made of metal they were rubbish because they

were flexible….so in that instance, the single use wasn’t as good as the

autoclavable version, so we’ve stuck with the autoclavable (11TM)

For these clinicians, disposable laryngoscope blades were perceived as providing a

greater threat to patient safety from iatrogenic injury than from cross infection. If the

blades were to slip, contort or flex unexpectedly, the patient’s larynx could be

damaged. Concerns regarding perceived differences in the efficacy of single use

laryngoscopes compared to reusable devices were also voiced by another

anaesthetist:

It’s okay if it’s an easy intubation but then you know that’s not really the issue

it’s, the problem is the one whatever it is that’s actually a bit more tricky,

requires a bit more force and sometimes, but not always, but sometimes it’s a

life, you’re in a life critical situation and you can’t have your equipment not

being up to the job, you don’t know which of the patients that will happen in

so you have to have an instrument that’s going to be able to do it for every

90

patient unfortunately. And I’m saying unfortunately because that means

slightly more cost implications (2CDA)

There seems to be a distinction between equipment that is acceptable for use with a

routine patient, and equipment that is incompatible with difficult cases. However,

when treating difficult cases, participants felt that they did not have time to source

alternative equipment, but wanted to be able to rely on the devices to hand, and so

often turned to reusable kit:

It’s nice to know that you’ve got the back up of the emergency reusables,

handy for safety reasons. Because every individual can do very strange

things suddenly in an anaesthetic, so I think it would be very foolish to go

over. It would be very foolish to get rid of all the reusable laryngeal masks

(3ODP)

These comments reinforce Twigg et al’s107 warning about the need for equipment to

be fit for purpose. One anaesthetist commented:

Sometimes I think ‘I’m using this single use laryngoscope blade and I don’t

think it’s as good as the one I would like or it isn’t shaped in exactly the way

that I’m used to’ and therefore my practice is probably inferior to what it would

be if I’d got a re-sterilised laryngoscope (7CDA)

Whilst the use of single use laryngoscope blades was mandated because of the

theoretical risk of cross contamination from prions, the unsatisfactory quality of some

laryngoscope blades has resulted in actual risks to patients’ health and safety.

Hutton108 described how:

New, inferior equipment has now claimed its first victims and the real danger

of responding to theoretical risks in the face of practical experience has been

exposed. The message is clear: hypoxia threatens life in minutes,

haemorrhage in hours and tonsilla prions (maybe) in decades.

Disposable laryngoscope blades were also criticised for their inadequate light source.

Two anaesthetists explained:

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There have been some queries about the quality of some single use

equipment. The [laryngoscope] blades aren’t quite good enough to offer you

as excellent a view as you might wish in difficult patients, but I know the

quality of them has improved quite a lot (5CDA)

Single use laryngoscope blades led to a higher risk of failed intubation, as

plastic blade was more flexible and had a poorer light source, but disposable

blade is in the patient’s best interest in terms of risk transmission (4CDA)

Rassam’s et al’s109 evaluation of 20 Macintosh type laryngoscope blades included 19

single use blades sourced from different manufacturers. Anaesthetists were asked

about the quality of illumination given by each blade, their satisfaction with the

resultant view, and their perception of clinical appropriateness. Two plastic single use

blades were found to have a poorer illumination score than the others, and one of

these blades was also found to result in an inferior view that was perceived as being

a disadvantage in clinical use. The illumination quality of laryngoscopes is clearly

important, as a difficult view of the larynx is associated with increased morbidity 108,110.

Many of the respondents criticised single use devices in terms of the potentially fatal

outcomes from the use of ineffective equipment. The strongest criticism related to

single use bougies:

With regards to the bougies, I know there are new bougies which cost a fiver

compared to the £85 gum elastic ones, which look similar, but I have to say,

they don’t function similarly at all. And one of the areas that we are unhappy

about is that the gum elastic bougie has been replaced by a plastic thing, and

I am slightly concerned that they get put back and somebody thinks of

washing those out and using them again. We do say that they are disposable,

but they certainly don’t function as well: they’ve got flat ends as opposed to

the parabolic ends, and they don’t have the nice characteristics of bendy and

then gradually take the shapes of things, so if you bend it, it manages to get

into position and smoothly glides in, but this one flatly doesn’t want to go in,

and in slightly straightens as you put the [endotrachael] tube over it, so the

older one did function significantly better. The new ones could potentially

present at problem (6CDA)

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The altered design of bougies led participants to describe them as ‘substandard’,

‘dangerous’ and ‘awful’. The main area of concern, as implied in the quote above,

was the single use bougie’s failure to retain its memory of shape. One ODP

compared the efficacy of the original, reusable gum elastic bougie (Eschmann) and a

single use bougie:

They’ve got memory on them…. the gum elastic Eschmann [now Portex

Venn] one, and Cooke have got one as well, they’re blue, and basically when

you bend them up if you’ve got a very anterior larynx, when you bend the tip

up by the time you put the laryngoscope in you want that bit to stay in the

position and with the Portex [single use] one, they’re just urgh. A lot of the

anaesthetists still keep them in their briefcase, their gum elastics, you know

it’s just their little security blanket (3ODP)

The inability of the single use bougie to retain its memory has been acknowledged,

and the Portex device deemed inappropriate for use as an intubation aid111. Wilkes et

al112 found that single use bougies tended to be stiffer than their reusable

equivalents. Annamaneni et al113 compared the ability of single use and multiple use

bougies to retain their shape, and found that multiple use bougies were superior

(figure 13). The authors demonstrated the bougies’ ability to retain their shape via a

time-motion image captured over four seconds:

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Figure 13: Time motion capture of memory retention of single use and multiple use

bougies113.

The manufacturers recognise that the performance of the reusable bougie has been

difficult to replicate in the single use equivalent114.

Concern was also expressed about the quality of anaesthetic breathing circuits. One

anaesthetist compared the ‘sturdy’ quality of old-fashioned circuits with the ‘flimsy’

tubing that is now used:

I think things like anaesthetic circuits, there clearly has been a change from a

very sturdy horrible black rubber stuff that was sort of just going out when I

first started anaesthetics but now has completely gone, to what we have now

which are very flimsy circuits and in fact actually are kept on machines for a

week. I don’t know if they’re supposed to be single use or not but they are

kept on for a week here (2CDA)

The fragility of breathing circuits has recently been noted by the MHRA115 in

MDA/2005/062, which warns against the entrapment of breathing circuits between

the operating table and patient transfer trolley, following one patient fatality and

hypoxic brain damage to another.

Similar comparisons were made between the robustness of other disposable and

non-disposable devices. For example, the original LMA developed by Intavent

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Orthofix, was considered to be the gold standard, with respondents describing how

“nothing is as good as the reusable to be quite honest” (3ODP). Compared to the

original LMA, which has a “plastic balloon on the end of a tube [compared] to a nice

soft latex one” (4ODP), laryngeal masks developed by other companies were

reported to vary in design details and to be made of different materials. These

differences have resulted in clinicians perceiving the masks to be bulkier, which

resulting in tissue trauma and damaged teeth, as well as not producing as good a

seal as the original LMA. One anaesthetist explained:

Certainly some of the laryngeal masks that we are using now, compared to

the original design which looked like it was latex, but in fact wasn’t, it was

made of slightly softer material, the plastic ones that we are using now are

much cheaper, but also they do appear to be much cheaper and there is a

small risk of not getting as good a seal, of causing direct trauma, especially if

people are worried about knocking teeth out with them, as they are bulkier to

put in (6CDA)

Anaesthetists were not solely concerned with the threat of tissue trauma or damage

to the teeth. One anaesthetist was vehement in his assessment of single use

laryngeal masks:

Disposable laryngeal masks can be dangerous and can deform if the patient

has a difficult airway (4CDA)

The materials used in devices also influenced clinicians’ views of a lack of risk in

reuse:

Things like metal Magill forceps that are single use and I know that you could

use probably them more than five times….It can be autoclaved because it’s

metal firstly, it can be cleaned because it’s a smooth surface and they’re not

used in a way that could, if they were damaged it wouldn’t harm the patient.

So I’d be quite comfortable with doing that. Because it’s metal and it’s robust

and there’s nothing electrical on it that can go wrong, there’s nothing on it that

can harm the patient, it’s two pieces of metal with a bolt in the middle of it so

it’s not going to go wrong (11TM)

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However, whilst devices such as Magill forceps are made

from a metal composite, they are not designed to be reused.

Lower grade composites are used due to the single use

nature of the devices, and consequently, it is possible that

they might fail as a result of being autoclaved. Moreover,

there are small areas on the device that may retain tissue or

blood debris if the device came into contact with the clinical

site or other used instruments.

Despite these specific criticisms, there was a general satisfaction with the quality of

single use devices. Although clinicians might have reservations about device

efficacy, most respondents insisted that, in terms of infection control, the use of

single use devices was in patients’ best interests. This contrasts with findings from

previous research that found anaesthetists reluctant to change from reusable to

single use devices because of concerns about possibly sub-optimal quality116.

In some cases, reuse was sanctioned because of the need for emergency treatment:

There is urgency when a patient needs

an Ambu bag; it is therefore kept

unwrapped. However, as recovery is

unlikely, potential germs and dirt from

unwrapped kit are less of a concern

(9ODP)

This respondent reported throwing away SUDs which had been unused in theatres

but left unwrapped, claiming “a lot of things we end up wasting because if something

is opened, personally, that’s used. I don’t know where it’s been, if I can’t, if I didn’t

open it and I don’t know it’s safe then I chuck it in the bin”. Yet in an emergency

situation, this policy was overridden: the patient needed to be ventilated, and the risk

of hypoxia outweighed the risk of cross infection, echoing Hutton’s120 comments.

However, our respondent also pointed out that the patient was unlikely to survive, so

action with a risk of iatrogenic cross infection was acceptable, if their life could be

saved. Nonetheless, it is not only the risk of cross infection and contamination that is

an issue. We have already referred to the blocked anaesthetic tubing incident at

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Chelmsford and the potential hazard of foreign bodies becoming lodged in devices

left unwrapped prior to use.

In other cases, reuse was blamed upon a lack of clean equipment and delays in the

sterilisation process. This was especially likely when the supply of certain devices

was limited:

We still have in the Trust laryngoscopes that are specific to situations so

you’ve got different types of laryngoscopes, like McCoy laryngoscopes,

you’ve got polio blade laryngoscopes all of which are, can’t be thrown away,

they’re too expensive so we still have to wash them. I mean in an emergency

situation we would have to wash then put them straight back into use,

otherwise we send them to CSD and they get washed and sterilised and then

brought back to us. We have to gauge every situation on its merits, if you

know you’ve only got one of them it’s not safe to let them go out of sight for

basically six hours until we get it back (2ODP)

Problems and delays linked to the turn-around time for sterilisation departments were

present in many of the accounts received from staff employed in hospitals that still

used reusable laryngoscopes:

We have had problems with the CSD turn around time so we’ve been running

out of laryngoscope blades…they’re sent to the CSD after each patient, so of

course then we’ve got to wait for them to be turned round to get them back

into the department (11ODP)

The CSD turn around time varied according to whether the sterilisation department

was onsite (3-4 hours) or off site (24-48 hours). Given this delay, in addition to the

possibility that devices may be damaged during the sterilisation process, and the

likelihood of general ‘wear and tear’ of devices, extra equipment would be needed to

manage the gaps that would arise117. In turn, this will have cost implications.

The use of single use devices is frequently criticised in terms of the perceived waste

and environmental impact from disposing of equipment after just one use. Collignon

et al’s12 study of Australian healthcare facilities found that reuse of single use devices

was justified by respondents in relation to the minimisation of waste and

environmental concerns, whilst Smith and Berlin118 argued that reuse of single use

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devices has been driven by the financial cost of disposing of increased volumes of

medical waste.

One issue may be whether certain devices are unnecessarily labelled as single use.

For example, single use laryngoscopy equipment is available in two formats: a single

use blade (Figure 14), which is connected to a reusable autoclavable handle (ade Figure 15), or a single use laryngoscope, in which both the handle and the blade are

disposable.

Figure 14: Single use laryngoscope blade Figure 15: Reusable laryngoscope handle

Respondents questioned whether all parts of the laryngoscope needed to be

disposable:

We have the whole thing, handle and everything. And I think they’re very

wasteful personally, and I think it’s something that we will review in the future

(2TM)

Well laryngoscopes certainly, a very important piece of our equipment, it’s not

only the blades now the whole damn thing is thrown away (7CDA)

The language of waste was also used in relation to devices like infuser bags and

blood pressure cuffs which, as discussed earlier, are unlikely to be in contact with the

clinical site or contaminated with blood or other infective agents:

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It’s such a waste of money. If you have one of these [pressure infuser] bags

per patient, sometimes you can be using two or three bags per patient, if

they’ve got you know, a number of IVs up, you can be using them, but it’s

such a waste, it really is (11ODP)

Unlike laryngoscopes, pressure infuser bags could simply be wiped down by an

ODP. The single use nature of the device was therefore treated with scepticism, in

accord with Stewart’s119 analysis in the course of a discussion of the ‘spurious

labelling’ of some single use devices:

Disposable pressure infuser: This consists of a bladder with an external

sleeve and an inflating bulb. A plastic bag of sterile fluid for flushing an

artery or other vessel is placed inside the infuser sleeve and the bladder is

inflated. This insider of the sealed bag is sterile; the external surface which

is in contact with the infuser sleeve does not need to be sterile. The

potential for nosocomial infection from this device is probably less than that

of a blood pressure cuff.

The rise of single use devices was certainly seen by some respondents as an

extension of a negative feature associated by them with modern consumer societies:

It’s just a throwaway society isn’t it, I mean, that’s what everyone wants, its

convenience (4TM)

It’s so wasteful, largely unnecessary. I don’t know what the next generation

are going to think of us wasting all these valuable resources and throwing

them away….the earth will run out of resources and the next generation will

be appalled (7CDA)

A secondary outcome from the use of single use devices is the environmental

pollution caused by their destruction109,119,120. The majority of single use devices are

made from plastics or lower-grade metal, and must be disposed of via landfill or

incineration:

I do worry about the environment as well you know which is a negative, you

know the amount of rubbish we throw out is just incredible. It is all plastics

and not biodegradable….it’s not very eco-friendly (3ODP)

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Well it’s all incinerated and clearly that adds to our environmental pollution

(2CDA)

Cook120 asks whether such a disposal strategy is environmentally responsible, while

the World Health Organisation121 has called for the impact of environmental exposure

to healthcare waste to be minimised. However, the environmental risks or hazards of

disposing of single use devices were contrasted with the threat to patient safety if

such devices were not used:

I know it’s not good for the environment particularly….[but] because of the

CJD most anaesthetic invasive things are around that dangerous area that I

think it would be going backwards to look at reusable (3ODP)

It does seem a shame that this metal is then, goes to the furnace and can’t be

recycled but that’s the way that it is at the minute. It can’t even be melted

down and you know re-extruded or something else but the fear is over you

know disease transmission that we don’t know about I guess, though what

could survive flames I don’t know (2CDA)

The environmental impacts of using single use devices, whilst unfavourable, were

considered by the majority of participants to be tolerable compared to the risk of

iatrogenic infection and the threat to patient safety.

Whilst we have no evidence to suggest that reuse of invasive single use devices is

occurring in the NHS because of the current financial situation, such a practice has

been reported from the USA122,123,124. Cost was however, an influencing factor in

purchasing decisions. Many respondents felt that the cost of the item held more sway

in Trust decision-making than its quality or clinical effectiveness. One theatre

manager described the decision-making and procurement process for purchasing

new devices:

The first driver to what we do is cost, that’s the first thing we look at. Then we

look at how effective the product is second after that (11TM)

Such a scenario however, is not unique to our data or the present period of financial

difficulty for the NHS. Discussing data collected between 2003 and 2004, McDonald

et al125 highlight the discrepancy between cost and quality of goods. They cite a

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hospital manager, who explained that staff knew they were “working with sub-

standard equipment….we are all under pressure to keep our budget in line” (p.190-

191). We received similar accounts from clinicians in this study, all of whom were

critical of the need to contain costs, regardless of whether the device in question

represented good value. To reinforce the argument, one ODP even compared the

Trust’s purchasing patterns with a particular supermarket brand that is known to offer

cut-price bargains as well as generally lower priced goods:

We have to go with the cheapest option…I call us the ‘Netto’ of the NHS

(11ODP)

We just go for the cheapest all the time, the cheapest, the cheapest but it’s

not always the right way to look at it you know. Something might be cheaper

but it might only last half as long (13ODP)

This last quotation reinforces one of the most important findings of this phase of the

study: the relationship between cost and value or quality.

Participants perceived that single use devices were more expensive pro rata than

reusable devices. For example, a single use laryngeal mask costs approximately

£6.50 and a reusable one, which might be expected to be used up to 40 times, costs

£62 13. Such a price differential influenced the hospital’s decision regarding what

equipment was available for use:

We would prefer single use things, but there are problem with the cost of it

(7TM)

We thought long and hard about reusables verses disposables and we

moved down the route of trying to use disposables for everything. The thing

we found with laryngoscopes is the cost implications of that are phenomenal

really. Disposable blades really are prohibitively expensive (4CDA)

We’re still on reusable laryngeal masks because you know it’s the cash, yeah

you get probably triple the value out of a laryngeal mask, a reusable one

13 All pricing figures are taken from the October 2004 edition of the NHS Purchasing

and Supply Agency’s catalogue57.

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about £90 and a single use one £4, £5 and you can understand why we do

that at the moment (6TM)

The perception that reusable devices offered greater financial value is based on the

logistics of repeatedly purchasing and disposing of single use devices. However, this

perception is frequently misinformed. When the full lifetime and organisational costs

of each device are factored into the financial equation, single use devices are

unlikely to be any more expensive than reusable devices, and in some cases may

actually be a cheaper option. Given the compartmentalisation of hospital budgets,

few units actually ‘see’ the real costs of reusable devices, as, once they leave the

operating theatre, they are ‘out of sight’ until returned clean and ready for use.

Device users will not experience the costs incurred in decontaminating a reusable

device (including transport of equipment, decontamination, cleaning, sterilisation and

repackaging and return to local storage) or shuffling operating lists so that the

required equipment is available. Many respondents only considered the immediate

purchase price of single use devices rather than the total lifetime or organisational

costs of reusables. For example, if a laryngeal mask could be bought for £5 and

reused on a second occasion, then £5 would have been saved. However, even a

relatively crude analysis demonstrates that single use devices may actually present a

cheaper option, as money is not spent on reprocessing:

There is an increasing trend to get more and more single use. There’s often a

financial implication behind it (7ODP)

More and more has been single use just by the mere fact of all

decontamination issues are reprocessing issues that items would create and

so that you know it’s almost becoming cost neutral when you actually weigh

both up (3TM)

£5 a use [for a single use laryngeal mask] is actually very good, it compares

very well with the reusable mask that costs I think over £100 because they’re

never actually used the forty times they could’ve been used because for

some reason it would been lost to the system and then on top of that you

have to add the cost of autoclaving, packing and what have you so clearly £5

for a single use is great (2CDA)

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Additional expenses incurred with reusable devices may also include the disruption

caused by the return of damaged or broken equipment from the CSD, which is unfit

for use. This may cause delays and cancellations, which result in unused theatre

time and staff and, possibly, extend the length of in-patient stays, with additional

costs and risks. Lastly, reusable equipment rarely seems to last as long as its

designated lifespan, which appears to be calculated for optimal handling and

reprocessing conditions rather than average experience. Reusables either get lost or

sustain general wear and tear that compromises their usability:

One of the problems we had with laryngeal masks was that they never seem

to get to 40 usages by the mere fact they get slung in bins, they get

damaged, the cuffs get split or they just disappear into the ether and that’s

one of the reasons we look for, to move into single use masks because like if

you’re not getting the full life out of the whatever product either you’re using it

incorrectly or clearly if stuff is getting damaged and disappearing we never

knew where they disappear to (3TM)

Things like laryngeal masks, they don’t go in a black hole – they get taken out

of the Trust. In this Trust alone, an event happens and all the laryngeal

masks disappear, as the consultants go off to the VIP tents with them. At the

same time, you can’t really use them for 40 times. You can’t really clean them

the first time, let alone the second, third or fourth (6SM)

This last quotation re-emphasises concerns about the degree to which reusables can

be adequately cleaned and decontaminated. However, until clinicians have a more

accurate perception of the lifetime and organisational costs of reusable and single

use devices, the balance between cost and benefit is likely to be set at an

inappropriate point.

Variations in the perception of risk also affected the trade-off between costs and

benefits. Where participants thought that the risks had been exaggerated, as

discussed earlier, they were more reluctant to incur the perceived costs of single use

devices. SUDs were not seen as the most cost-effective investment for protecting

patients against iatrogenic infection:

I mean the amount of money we spend on disposal anaesthetic equipment

could be better used on patient care in other areas that’s for sure. I mean I

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think in the history of anaesthesia there’s never been any major

recontamination of a patient from the breathing circuit (4TM)

Another anaesthetist spoke about the exaggeration of risk and compared the

risk/benefit ratio of infection prevention and single use devices to the policy of placing

cardiac defibrillation equipment at rail stations:

We do risk analysis and try to relate it to reasonable risks and reasonable

costs of procedures, and certainly we use various constraints to what are

reasonable risks and you can use things like ‘numbers needed to treat’, or

you can do it as ‘costs per patient per beneficial life afterwards’, or ‘quality of

life adjusted indicators’. So there are ways of doing these things. I mean, this

is a demonstration of the fact that this current Government has decided to put

defibrillation things at all railway stations in case anyone has a cardiac arrest.

It gets good press, but actually you need to spend about £300 million to save

a person (6CDA)

These respondents thought that a disproportionately large financial outlay was being

made for the health gain achieved, rejecting Webster’s126 argument that “the cost of

a single case of significant iatrogenic harm that would pay for a great deal of patient

safety”. Other respondents were more risk averse, and echoing Webster, considered

that the cost of safety outweighed all other costs:

If safety means you need single use, then you must use single use regardless

of cost issues (4CDA)

I think the biggest thing, ignoring the cost, is that if it is going to benefit the

patient, then you must use single use (7TM)

The patients have to be a priority in everything, from my point of view,

regardless of the costs, because that’s what we’re here for. If we need to

change anything, then it has to be right for the patients. That may then lead to

funding issues (9TM)

Despite the financial implications, one Trust even went as far as using a reusable

orthopaedic cannulated screwdriver as a single use device as the sterilisation

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department could not guarantee that it would be contaminant free due to its small

bore:

A lot of the instrumentation we use, say for putting screws into feet, they

should be more than one use but we have found with our CSD, who sterilises

our equipment, that because the equipment was so fine bore that they

couldn’t guarantee the cleanliness, so we’re now using those instruments,

that should be used time after time, as single use instrumentation now. It

might bump costs up a bit, but at least we are sure that there is no

contamination going into patients (6ODP)

The device in question was reported to cost in the region of £200, but was being

discarded after just one procedure.

These quotations reflect the typical perception that single use devices are indeed

safer than reusable equipment, although they also demonstrate the common

reluctance of practitioners to recognise the need for cost/safety trade-offs. Whatever

qualifications they introduced, most respondents were quite clear that the use of

disposable devices was in the patient’s best interest, and typically referred to this as

‘best practice’:

For patient safety, it is probably the only alternative (2CDA)

We prefer to stick to single use, I think that’s best practice really (3ODP)

I think we have an obligation to do the best for the patient (9TM)

As a result, respondents looked to use single use devices wherever possible:

I think the more we’ve got, the safer it is for patients (6ODP)

Respondents rationalised that if they, or anyone close to them, were the patient, they

would want single use devices to be employed in their treatment, and they felt that

other patients should not be offered a lower standard of provision

I think the most important thing is that we, as professionals need to make

sure that what we use on the patient, we would be happy to accept for use on

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ourselves or any member of our own family, and looking at the guidance and

using that guidance thinking, ‘is this the best practice that we can give the

patients’? (9TM)

I think if I was ever in that position, and was the patient having an operation, I

would really prefer that single use was used on me (6ODP)

I want platinum standard – if I could go higher I would. But it costs money to

have platinum standards. I don’t care what the costs are. That’s the standards

that we have to have for our patients. I work on the principal that I’m the

patient. You know, if this is being used on you, then I would want it to be used

on me. I’ve had surgery here, as have my family, and I’m very happy with the

standards here (6SM)

These findings echo the results of a US survey, where 82% of all nurses and 71% of

all surgeons questioned reported that they would feel wary if a reprocessed device

was used on them60. Similarly, Walsh83 carried out his own ‘straw-poll’ of UK theatre

staff, and found that “almost all would prefer an unused laryngeal mask airway for

their anaesthetic, because they see them contaminated with blood and secretions”.

However, as we have already discussed, the perceived safety of single use devices

is to some extent at odds with perceptions of their quality and efficacy. One ODP

acknowledged:

Lots of things aren’t as good you know, you buy cheap and it looks cheap and

it doesn’t work properly, so you know, you have to weigh up the pros and

cons: is it going to be safe for the patient or not? You know certain things are

good, some, and you just, you have got an alternative but it might be

expensive (4ODP)

The appearance of the device, the cost of the device and the functionality of the

device all combine to create the clinician’s perception that buying cheaper devices

does not always save costs in the long-term:

We go for value, we will always consider cost, but we’ll also consider how it

does its job. It’s not good buying a thre’penny laryngoscope blade that

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doesn’t work, you know it’s cheap as chips but if it doesn’t work then you

know you’re endangering people (9ODP)

As Webster98 suggests, in the long-term, it may be cheaper to follow good clinical

practice in relation to patient safety (and single use devices) than face the financial

implications of an episode of iatrogenic harm. It is not, however, just the financial

threat of iatrogenic harm that should influence the purchasing decisions in relation to

single use devices. These devices can also accelerate workflow and produce quality

and efficiency gains. For example, the adoption of single use devices in the context

of new surgical technologies can reduce the time the patient spends both under

anaesthesia and as an inpatient:

The staple guns and things like that we use are a one off item that tend to

actually save time and will knock half an hour or more off an operation (4TM)

A couple of weeks ago we did a laparoscopic nephrectomy…the patient was

walking around the shops within four days. You know, do a loin incision like

that, and the patient will still be in bed in ten days’ time because he can’t

move, you know it’s, there’s a benefit for all these things to be done. But

we’re just paying maybe a little bit more cost. You know, if you open a patient

the patient is going to be in hospital for a fortnight, you have to pay that, but

what we’ve saved on bed days’ cost, the disposables have cost nothing

really. And I think that’s the way you’ve got to look at it, if it’s going to save a

patient being in hospital, they don’t like being in hospital for ten days or a

week when they can be out in two, you know for a gall bladder, out in two

days, probably less you know (4ODP)

The latter quotation demonstrates a problem with the organisation of the NHS

hospital accounting. As our data show, theatres are under pressure to use the

cheapest possible equipment, yet by performing a slightly more expensive procedure

(for example, laparoscopic rather than open surgery), the extra money spent may be

more than recouped by a reduction in the number of bed days needed and

anaesthetic gases required. As laparoscopic surgery is less invasive and often

quicker, the patient’s recovery time is shortened. Yet, the compartmentalisation of

Trusts’ internal budgets can mean that these savings are not recognised by the

purchasing decision making process. Such a scenario was recalled by an ODP:

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A lot of the single use disposables that we use save a lot of time, because

like, I can remember for years, we’d take out pieces of a patient’s bowel and

then you’d have to sew them up, it’s much more time consuming than having

a stapler or putting clips in. It’s beneficial to the patient in as much as it’s a

new instrument and it saves time, so there’s less anaesthetic. So then, its

cost effective I guess in a way. The financial part of the hospital don’t really

understand dare I say….If they looked at the whole picture, like laparoscopic

bowel surgery, once you’ve got all the kit, the patient is on the table for less

time and is only in hospital for a few days rather than two weeks (6ODP)

Our data suggests that whilst a variety of constraints affect the decision whether or

not to use single use devices, the primary influences are cost, quality and the

perceived benefit, or otherwise of using disposable equipment.

Specific data on lifetime and organisational costs was hard to obtain from Trusts.

However, we can demonstrate the principles discussed in the last two sections

through a fairly crude analysis of the choice between reusable and single use

laryngoscope blades. Whilst a single use laryngoscope blade is known to withstand

less force and produce a poorer light source than a reusable blade106,127, the risk of

infection or cross contamination from reusable devices is well documented 79,109,128.

Estimates, based on figures in the NHS Logistics catalogue57 and data supplied from

Hospital 3, suggest the following costs:

• Purchase price of a single use laryngoscope handle and blade: £10.70

(average)

• Purchase price of a reusable laryngoscope handle and blade: £120.00

(average)

• However, the reusable device will be used repeatedly, and will undergo a

sterilisation cycle after each use. Using data supplied from Hospital 3, the

sterilisation cost is calculated at £2.50 per item. Hospital 3 estimated that

their laryngoscopes were each used approximately 330 times per annum 14

• Estimated cost of each use of a reusable laryngoscope is therefore: £120.00 /

330 + £5.00 = £5.36

14 It is appreciated that the period of use for a laryngoscope blade could be far less

or far more than a year.

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However, it is important that other handling and related costs are also included in this

financial calculation. While reusable devices appear to present the cheapest option,

the figures do not take account of the relative risks of infection, generating additional

costs in compensation, additional treatment and extended in-patient stays, the need

for additional reusable stock to buffer the time lag between sending equipment to the

CSD and receiving it, and the impact of missing or broken equipment on the

continuity of theatre working. While these figures are not conclusive, there is every

reason to suppose that the actual cost per use is much closer than the calculation

suggests.

Prior to the inauguration of this study, we had envisaged conducting a formal

economic evaluation, entailing the measurement of costs and benefits. Our

presumption had been that the reuse of SUDs would be both explicit and pervasive,

and that cost and consequence data would be readily collectable. However, during

the course of the study, it became increasingly apparent that, if widespread reuse

was indeed occurring, it was not a matter which individuals within organisations were

prepared to discuss in detail openly. Trusts were unwilling or unable to provide

financial data pertaining to the reuse of SUDs. In only one case was any relevant

economic material made available. This took the form of an uncontroversial

assessment of whether or not to initiate a move from reusable to single use

equipment in a specific context. Understandably, suppliers and manufacturers of

devices were unwilling to release details of actual prices charged or the volume of

sales, owing to concerns over information being made available to competitors. The

unavailability of data has made a formal quantitative evaluation impossible.

This having been said, the data obtained at interview have enabled us to explore the

series of behavioural propositions and hypotheses which we had established initially.

These were essentially economic constructs, potentially explaining micro-behaviour

with respect to single use devices in terms of expected costs and consequences. The

evidence necessary to explore these hypotheses has already been presented

throughout the report. Here, we state six hypotheses and summarise the evidence

available in support or otherwise, before reaching an economic model of the need to

balance cost and benefit in the decision to reuse SUDs. The behavioural propositions

pertain to choices made by individual agents at the appropriate stage of a decision

process, the choice being between:

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• Should I employ a new single use device?

• Should I re-employ a previously-used single use device?

• Should I employ a reusable device?

Hypothesis 1

Interpreting behaviour as a result of the above three-way choice presupposes

that the decision maker is aware that the device is intended for single use.

There is some evidence that unfamiliarity with the device per se or lack of clarity in

the manufacturer’s instructions can lead to errors in usage, of the form of either (i)

reusables being discarded unnecessarily or, (ii) single use devices being reused

inappropriately. Whilst that inappropriate usage may be unintended, there are still

cost and outcome consequences. Given that the price of reusables tends to exceed

that of single use devices by a wide margin, the former error represents waste for no

health gain, whereas the latter represents cost saving accompanied by a potential

health risk.

Hypothesis 2

Reuse of single use devices can save money. Having been purchased for

the first procedure, the cost of reusing the device is (i) zero for the device

itself, although possibly (ii) positive, if maintenance or reprocessing (e.g.

cleaning) is required. In general, therefore, reuse will be cost-saving if

reprocessing costs are less than replacement costs.

The US General Accounting Office122 study identified cost economies as a principal

explanation for reuse:

Substantial cost savings can be achieved by reprocessing SUDs.

Independent reprocessing firms charge hospitals approximately one-half the

price of a new device, while the in-house cost of reprocessing some devices

can be less than 10 percent of the price of a new device. The competition

created by SUD reprocessing appears to have caused some original device

manufacturers to reduce their prices to certain purchasers (p.5)

However, unlike the USA, in the UK reprocessing of devices by 3rd parties does not

occur. Accordingly, cost advantages following reprocessing may not be so apparent.

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There were no reported cases of single use devices being reprocessed officially, yet

reuse was obviously occurring. Although cost saving was the most commonly cited

justification, it was not at all clear that the respondents were accurately informed

about the financial implications. Their intuition, in other words, may have been

leading them to believe that reuse “must” be cheaper.

Hypothesis 3

Reuse increases security in supply. If an SUD is necessary for a procedure

then the availability, or otherwise, of the SUD will act as a potential constraint

on that procedure being undertaken. For any given level of stock of the SUD,

reuse increases the likelihood that the procedure will be feasible. Given the

variability of demand for procedures and the possibility that many demands

could be emergencies, non-reuse will require more SUDs to be held in stock

at any one time (with implications for storage costs and tied-up capital).

Our data tend to contradict this hypothesis. SUDs are generally considered superior

to reusable equivalents in terms of security of supply, for three reasons: (i) automatic

stock replenishment systems mean that SUDs are replaced following use as a matter

of routine. Reusable devices have a longer life and therefore require more conscious

ordering, which is vulnerable to mismanagement. (ii) Reliance on a limited number of

reusable devices entails supply insecurity if one or more devices are mislaid,

damaged or are undergoing cleaning. (iii) If the supply of reusables is limited,

individuals face the incentive to reserve devices for their own usage, e.g. by means

of concealment, thereby disrupting supplies for other users. The only exceptional

circumstances would appear to be emergencies, when SUD reuse may be justified

on the basis of needing to use the nearest device available.

Hypothesis 4

Reuse eases the management of patient care. Depending on the practices

of the institution concerned, it might be the case that new SUDs are more

difficult to access than used ones, owing to, for example, physical distance,

need for authorisation and "red tape". Where a maximum level of use of

SUDs is an efficiency criterion for a unit, reuse would enable the unit to reach

its target more easily (or make the unit appear more efficient).

Little information was forthcoming in this area, suggesting that accessing SUDs was

not a particular cause of concern. We infer that individuals who cite the need to save

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resources as a justification for reuse must be faced with either budget constraints or

performance targets because, without these, cost saving behaviour would be

unnecessary.

Hypothesis 5

The user believes the old SUD to be superior to the new, despite the

intentions of the manufacturer, e.g. the old SUDs were "better made" than the

new ones, the old ones work better as they are "worn in".

Support for this hypothesis was reflected in the data, but in relation to the debate

regarding reusable vs. SUDs (e.g. bougies, laryngoscope blades). Certain SUDs

were indeed perceived to be of poorer quality than reusables. Despite being new,

often lower cost, carrying no risk of cross infection or contamination, SUDs were

rejected on the grounds of offering sub-standard care.

Hypothesis 6

Reuse of SUDs risks contamination. Therefore, the decision to reuse

requires either that the user feels that reuse poses no threat to the welfare of

the patient, or that any increased risk to the patient is more-than-offset by the

advantages of reuse.

There was no evidence that individuals were unaware that, in general terms, reusing

devices posed some degree of iatrogenic risk. Individuals disputed, however, the

magnitude of this risk and the extent to which risk minimisation was consistent with

efficiency and effectiveness. A minority of participants admitted to covert attempts at

reprocessing SUDs. They perceived that objects such as stainless steel forceps were

able to withstand the sterilisation process and reuse would therefore entail no

significant risk. Others who admitted reusing items such as Flowtron boots, pressure

infuser bags and blood pressure cuffs, justified reuse on the basis that such items

were used away from the operative site and were therefore insignificant threats to

health. Both the USA122 and the Australian12,61 studies of SUDs concluded that risks

of adverse consequences following reuse were, in many cases, low. In the

Australian case, terminating reuse on the grounds of risk reduction alone was held to

be cost-ineffective.

These behavioural propositions may be integrated into a simple model of the choice

problem, as follows:

112

• Using the SUD appropriately costs [C + CD], where C = the unit cost of the

SUD and CD = the expected cost of its disposal

• Reusing the SUD costs [CR + RP], where CR = the cost of reprocessing

the SUD for reuse, R = the expected risk of an adverse consequence as a

result of reuse, e.g. infection, and P = the expected penalty incurred as a

result of an adverse consequence, e.g. cost of additional treatment,

litigation, compensation, etc

• Therefore, an SUD will be reused if the user believes [C + CD] > [CR + RP]

Different SUDs exhibit different characteristics, which explains why reuse is more

frequent for some devices than for others. On the basis of the model, the reuse of

any particular SUD is more probable when the individual contemplating its reuse

believes:

• The unit cost of the SUD is high

• The cost of its disposal is high

• The cost of reprocessing the SUD is low

• The risk of an adverse event following re-use is low

• The penalty resulting from an adverse event is low

113

Conclusion and Recommendations:

This study has found that, despite guidance to the contrary, single use devices

continue to be reused. Reuse appears not to be widespread, but sufficient to remain

a matter of concern 15. Whilst some Trusts reported that they risk assessed reuse, in

most cases, device misuse was informed by common sense assumptions and the

clinical experience of participants.

The reuse of SUDs has been described as medical experimentation101, yet, when

reuse occurs, it seldom seems to be a deliberate decision, other than when the reuse

of the device is considered to present little risk. Rather reuse is most likely to be as a

result of underlying (latent) factors, including the physical design of the devices,

organisational breaches and human failings. Risks to patient safety in terms of the

reuse of SUDs therefore go beyond the active errors of individuals who we might

think of as ‘deviant’ or ‘careless’. Rather, as this report has demonstrated, several

different factors influence breaches in patient safety. These latent threats can lead

even the best clinician to be involved in an error that has the potential to harm a

patient.

Single use devices were introduced following awareness that protein and bacteria

remained on instruments following decontamination and sterilisation processes. This

led to fears that patients may contract iatrogenic infections and diseases such as

vCJD, HIV and Hepatitis B&C. The use of single use devices, which by definition

should be used once and then discarded, removed this threat to the delivery of safe

care for patients: new single use devices are guaranteed to be clean and

contaminant free. Moreover, unlike reprocessable equipment, single use devices are

neither fatigued nor suffering from wear and tear. For the most part, the use of single

use devices is in the patient’s best interests.

15 It is appreciated that due to the shortcomings of the survey phase of the research,

these statements cannot be generalised or applied to Trusts across the NHS.

However, given the recurring patterns of practice that we found across three different

SHAs, we consider that our conclusions offer a representative summary of current

usage and reuse.

114

Despite MHRA6 guidance specifying that single use devices should be used once

and then discarded, we have found that reuse continues. In 2004 we undertook a

survey of frontline staff working in Acute English NHS Trusts. 62% of respondents

reported that single use devices had been reused in their hospital. Examples

frequently cited included: breathing circuits, laryngoscope blades, laryngeal masks,

gum elastic bougies, facemasks and compression garments. All (with the exception

of breathing circuits which is a ‘grey’ area in the regulations) are labelled as single

use, and most are used invasively when intubating the patient. Our interview study of

theatre staff, conducted a year later, found a lesser extent of reuse reported,

although this difference may simply reflect the limitations of both samples.

Current thinking is encouraging the health service to move away from a culture of

blame towards a culture of learning129. Consequently, whilst reuse might occasionally

be explained by actions of a rogue or deviant clinician, our interview data points to a

number of organisational and physical reasons why single use devices are misused.

Moreover, many of these findings present an opportunity for learning and

development, both for clinicians and the manufacturing industry.

Misuse of single use devices is most likely the result of latent factors, including the

physical design of the devices and organisational breaches, as well as active failures

linked to human fallibility. During interviews with clinicians, we became aware of

several physical reasons why single use devices might be misused, including:

• Misunderstanding of the definition

• Design characteristics

• Suitability and safety of other devices.

• Discrepancies in labelling

The safe delivery of healthcare is also threatened by organisational factors,

including:

• Lack of awareness about single use devices

• Perception that reuse of single use devices is cheaper

• Fragmented hospital budgets which have resulted in the true costs of single

use and reprocessable devices being obscured from clinicians

115

• Perception that cost is a more important driver than quality when making

purchasing devices

Reuse was also rationalised in terms of the financial implications of continually

purchasing devices after one use, and environmental concerns about their disposal.

Lastly, clinicians questioned the extent of the risk linked to reprocessable devices.

In our survey we asked participants if they were aware of any guidance relating to

the use of single use devices. Only one person explicitly mentioned the MDA6 device

bulletin. This finding has influenced the MHRA’s decision to re-release the document

in October 200693. Recent communication with an orthopaedic surgeon also

reinforces our argument that problems exist with the current communication

strategies employed by the relevant stakeholders. This surgeon reported that they

were unaware of the MHRA guidance regarding single use devices, and asked

whose responsibility it was to communicate this to practitioners. Medical Device

Alerts and Bulletins from the MHRA are automatically sent to Trust SABS (safety

alert broadcast system) liaison officers for onward distribution to all relevant staff.

Evidence shows that this method of communication is not working efficiently: staff

are either not getting the information or are ignoring it. Consequently, this means that

care has been or potentially could be compromised. We recommend that the

SABs/Trust networks are evaluated in terms of the uptake and distribution of advice

transferred via the SABs provision.

Given the current financial crisis in the NHS, we found two important links between

the use and misuse of devices and perceived cost savings:

• Reuse of devices is perceived to present a cheaper alternative to

repeated purchasing

• Cost is a more important driver than quality (and hence effectiveness and

safety) when making purchasing decisions.

Clinicians felt that by cutting costs, patients were put at risk. Cheaper single use

devices were perceived to be placing the patient at greater risk of harm than that

linked to the use of a reprocessable device. We recommend that these perceptions

are addressed, both substantively through the design and cost of devices, and

116

educationally, via an awareness programme aimed at clinicians. However, it is also

important that Webster’s124 stark warning be noted:

The cost of a single case of significant iatrogenic harm would pay for a great

deal of patient safety.

A fundamental question that has arisen from this research is how to deliver the best,

safest care to patients and at the same time protect the NHS from the higher costs

associated with such practice. Is it appropriate, for example, to continue to

repeatedly purchase and discard certain, non-invasive single use devices (which

most likely pose very little iatrogenic risk) when the NHS is in financial difficulties? Is

it possible to balance known financial risks against unknown risks of contracting an

iatrogenic infection linked to the use of a medical device? Which is more of a threat:

financial disaster or the potential for patient harm?

In contrast to clinicians concerns relating to the patient safety risks associated with

inferior quality single use devices, when the quality of the devices was not called into

question, a different stance was taken. Single use devices were considered

beneficial in that they protect against iatrogenic cross infection and contamination,

and ensure that each patient has clean instruments used on them. This research

clearly demonstrates that clinicians feel that the use of single use devices is in the

patient’s best interest. Moreover, the use of single use devices is seen to be a sign of

clinicians’ professionalism and adherence to good clinical practice standards.

However, as our data demonstrates, single use devices do not always function as

well as clinicians would want them to. Some are unfit for use and their use can

endanger the patient.

It is not our aim in this report to blame or identify individuals who have admitted to

reusing single use devices. Rather, the opportunity for shared learning and

improvement in the design and use of medical devices is considered to be a greater

good. This report and its Appendices outline the obstacles leading to the misuse of

devices, as well as providing a forum for clinicians to voice their concerns. It is now

for the regulators (including the Department of Health, Medicines and Healthcare

products Regulatory Agency and the National Patient Safety Agency), manufacturing

community, Royal Colleges and Royal Associations, front line clinical staff and NHS

managers to work together to address the problems and weaknesses identified in

this report. However, we offer the following nine suggestions:

117

1. Professional associations and Royal Colleges should work together to

address inconsistencies in infection control guidelines. In particular:

a. Use of single use laryngoscope blades

b. Contrasting guidance for different invasive intubating equipment

(laryngoscope, laryngeal mask, bougie)

2. Clearer microbiology guidance is required on the actual threat of vCJD and

other iatrogenic infections from reused devices

3. The definition of single use should be re-examined. Do the terms ‘single use’

and ‘single patient use’ describe the same expected usage pattern? If so, we

recommend that the term single patient use is removed from all devices.

Additionally, regardless of the resulting definition, a high profile educational

campaign targeting all stakeholders should be designed and implemented

4. Labelling inconsistencies need to be addressed:

a. Labelling on each device should be consistent. For example, a device

should not be labelled as both single use and single patient use

b. Labelling on the device, packaging and paper insert (instructions)

should be consistent

c. Size of single use logo, font and position of the logo should be

examined

d. Use of wording to replace single use logo should be examined

5. Colour coding of devices, thus differentiating between single use and

reprocessable should be investigated. Views of users, purchasers and

manufacturers will need to be sought

6. Robust system for the replacement of breathing circuits after seven days to

be designed and implemented throughout the health care system

118

7. All clinical stakeholders should revisit EGBAT’s100 fifth recommendation,

regarding removing devices from their packaging prior to use. Practice should

be amended where at odds with proposal

8. MHRA and device manufacturers to seek independent scientific expertise on

the contamination risks of certain single use devices (such as blood pressure

cuffs and pressure infuser bags) and remove the single use logo if evidence

suggests that this is feasible

9. All parties should look for ways to remedy the perceived quality/cost conflict.

Equipment must be fit for purpose in order to be both cost effective and

protect staff and patients against infection / cross contamination

119

Acknowledgments

We would like to acknowledge the support of colleagues in the Institute for Science

and Society and elsewhere in the University of Nottingham. Thanks are also

extended to those individuals who participated in the study, to BAREMA and in

particular to Harrie Cooke, for his helpful advice and guidance, to members of the

anaesthetic manufacturing community, and to all those individuals who have assisted

us in the completion of this study and shown an interest in our research.

Contribution of team members:

Professor Alan Aitkenhead: Advisor

Professor of Anaesthesia

Anaesthetic Safety

Professor Graeme Currie: Advisor and Interviewer

Professor of Public Sector Management

NHS Organisational Management

Professor Robert Dingwall: Chief Investigator; Co-author of report

Professor of Sociology

Organisational Deviancy, Patient Safety

Professor David Whynes: Author of cost-benefit analysis

Professor of Economics

Health Economics

Professor John Wilson: Advisor

Professor of Ergonomics

Human Factors; Design Safety

Dr Beverley Norris: Co-author of ergonomics report

Senior Research Fellow (Ergonomics).


Dr Sarah Sharples: Co-author of ergonomics report

Lecturer in Ergonomics

120


Dr Emma Rowley: Fieldworker; Co-author of report

Research Fellow (Medical Sociology)

Patient Safety, Medical Devices, Research

Governance

121

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109. Rassam S, Wilkes A, Hall JE, Mecklenburgh JS. A Comparison Of 20

Laryngoscope Blades Using Intubating Manikin: Visual Analogue Scores And

Forces Exerted During Laryngoscopy Anaesthesia 2005;60:384-394.

110. Rose K, Cohen MM. The Airway: Problems And Predictions In 18,500

Patients Can J Anaesth 1994;41:372-383.

111. Hodzovic I, Latto IP, Wilkes AR, Hall JE, Mapleson, WW. Evaluation Of

Frova, Single Use Intubation Introducer, In A Manikin. Comparison With

Eschmann Multi-Use Introducer And Portex Single-Use Introducer

Anaesthesia 2004;59: 811-816.

112. Wilkes AR, Hodzovic I, Latto IP. Comparison Of The Peak Forces That Can

Be Exerted By Multiple Use And Single Use Bougies In Vitro Br J Anaesth

2002;89: 671

130

113. Annamaneri R, Hodzovic I, Wilkes AR, Latto IP. A Comparison Of Simulated

Difficult Intubation With Multiple-Use And Single-Use Bougies In A Manikin

Anaesthesia 2003;58:45-49.

114. Reay J. A Comparison Of Multiple-Use And Single-Use Bougies Anaesthesia

2005;60:417.

115. Medicines and Healthcare products Regulatory Agency. Medical Device Alert:

MDA/2005/062 All Anaesthetic Breathing Systems London: Medicines and

Healthcare products Regulatory Agency 2005.

116. Scott SH. Put Your Money Where Your Prion Is Royal College of

Anaesthetists Bulletin 2002;March(12):598-99.

117. Esler MD, Baines LC, Wilkinson DJ, Langford RM.

Decontamination of laryngoscopes: a survey of national practice.

Anaesthesia 1999; 54(6): 587-592.

118. Smith JJ, Berlin L. Reusing Catheters and Other Medical Devices AJR Am J

Roentgenol 2001;177:773-776.

119. Stewart I. ‘Single Use Only’ Labelling Of Medical Devices: Always Essential

Or Sometimes Spurious? Med J Aust 1997;167:538-539.

120. Cook TM. The Classic Laryngeal Mask Airway: A Tried And Tested Airway,

What Now? Br J Anaesth 2006;96(2):149-152.

121. World Health Organisation Risks Associated with Healthcare Waste Health

Care Waste Management 2005

www.healthcarewaste.org/en/115_overview.html

122. General Accounting Office. Single Use Medical Devices: Little Available

Evidence of Harm from Reuse But Oversight Warranted 2002 GAO:

Washington DC.

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124. Klein A. Good as New? The Reuse of Medical Devices Hospitals Save

Money, But Safety Is Questioned Washington Post 11.12.2005: p.A05

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126. Webster CS. The Iatrogenic-Harm Cost Equation and New Technology

Anaesthesia 2005;60:843-846.

127. Evans A, Wilkes AR, Hall JE. Strength Requirements Of Laryngoscope

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132

Appendices

1. Inventory of Reuse

i. by device

ii. by country

2. Survey sampling strategy details

3. Ineligible survey data

4. Interview methodology details

5. R&D log (Interview phase)

6. Ergonomics report

13

3

App

endi

x 1.

Inve

ntor

y of

reus

ed S

UD

s

i. R

euse

by

devi

ce

R

euse

d S

ingl

e U

se D

evic

e R

efer

ence

D

ate

C

ount

ry o

f Orig

in

1 A

graf

Equ

ipm

ent

1 19

99

DE

NM

AR

K

2 A

mbu

bag

(Neo

nata

l)

2 20

01

CA

NA

DA

3 A

naes

thes

ia: A

irway

Con

nect

or

3 20

03

US

A

4 A

naes

thes

ia: A

irway

Dev

ice

4 20

04

NEW

ZE

ALA

ND

A

naes

thes

ia: A

irway

Dev

ice

5

2000

G

ER

MA

NY

5 A

naes

thes

ia: A

ngle

pie

ce c

onne

ctor

in P

CB

6

2004

U

K

6 A

naes

thes

ia: B

ite B

lock

2

2001

C

AN

AD

A

7 A

naes

thes

ia: B

reat

hing

Circ

uits

7

2000

U

SA

A

naes

thes

ia: B

reat

hing

Circ

uits

8

2000

U

SA

A

naes

thes

ia: B

reat

hing

Circ

uits

3

2003

U

SA

A

naes

thes

ia: B

reat

hing

Circ

uits

9

20

04

CA

NA

DA

A

naes

thes

ia: B

reat

hing

Circ

uits

10

20

01

CA

NA

DA

A

naes

thes

ia: B

reat

hing

Circ

uits

11

20

04

US

A

A

naes

thes

ia: B

reat

hing

Circ

uits

2

2001

U

SA

8 A

naes

thes

ia: B

ronc

hosc

ope

4 20

04

NEW

ZE

ALA

ND

A

naes

thes

ia: B

ronc

hosc

ope

3 20

03

US

A

A

naes

thes

ia: B

ronc

hosc

ope

3 20

03

US

A

13

4

9 A

naes

thes

ia: C

athe

ter m

ount

on

PC

B

12

2004

U

K

A

naes

thes

ia: C

athe

ter m

ount

on

PC

B

13

2002

U

K

10

Ana

esth

esia

: End

otra

chea

l Tub

e 3

2003

U

SA

A

naes

thes

ia: E

ndot

rach

eal T

ube

3 20

03

NEW

ZE

ALA

ND

A

naes

thes

ia: E

ndot

rach

eal T

ube

10

2001

C

AN

AD

A

A

naes

thes

ia: E

ndot

rach

eal T

ube

2 20

01

CA

NA

DA

A

naes

thes

ia: E

ndot

rach

eal T

ube

8 20

00

US

A

A

naes

thes

ia: E

ndot

rach

eal T

ube

7 20

00

US

A

11

Ana

esth

esia

: Filt

er

4 20

04

NEW

ZE

ALA

ND

A

naes

thes

ia: F

ilter

14

20

04

UK

A

naes

thes

ia: F

ilter

15

20

01

UK

A

naes

thes

ia: F

ilter

21

20

00

US

A

12

Ana

esth

esia

: Int

ubat

ing

styl

ette

s (b

ougi

es)

2 20

01

CA

NA

DA

13

Ana

esth

esia

: Int

ubat

ion

Equ

ipm

ent

1 19

99

DE

NM

AR

K

A

naes

thes

ia: L

aryn

gosc

ope

blad

es

16

2002

U

K

14

Ana

esth

esia

: LM

As

17

20

00

UK

15

Ana

esth

esia

: LM

As

18

19

99

EU

RO

PEA

N U

NIO

N

16

Ana

esth

esia

: Mas

ks

7 20

00

US

A

naes

thes

ia: M

asks

1

1999

D

EN

MA

RK

A

naes

thes

ia: M

asks

19

20

00

UK

A

naes

thes

ia: M

asks

3

2003

U

S

13

5

A

naes

thes

ia: M

asks

2

2001

U

S

17

Ana

esth

esia

: Mou

thpi

eces

3

2003

U

S

A

naes

thes

ia: M

outh

piec

es

7 20

00

US

18

Ana

esth

esia

: Neb

ulis

ers

14

2004

U

K

A

naes

thes

ia: N

ebul

iser

s 10

20

01

CA

NA

DA

19

Ana

esth

esia

: Ora

l airw

ays

2 20

01

CA

NA

DA

20

Ana

esth

esia

: Res

pira

tory

The

rapy

7

2000

U

S

21

Ana

esth

esia

: Spi

rom

etry

Tub

ing

20

2004

U

K

22

Ana

esth

esia

: T-p

iece

(PC

B)

12

2004

U

K

A

naes

thes

ia: T

-pie

ce (P

CB

) 13

20

04

UK

A

naes

thes

ia: T

-pie

ce (P

CB

) 2

2001

C

AN

AD

A

23

Ana

esth

esia

: Tub

ing

17

2000

U

K

A

naes

thes

ia: T

ubin

g 18

19

99

EU

RO

PEA

N U

NIO

N

24

Ana

esth

esia

:: O

xyge

nato

rs

22

2002

U

SA

25

Ang

iosc

ope

4 20

04

NEW

ZE

ALA

ND

26

Car

diac

: Aor

tic p

unch

es

23

2003

U

SA

27

Car

diac

: Bio

psy

Nee

dle

3 20

03

US

A

28

Car

diac

: Bur

r 3

2003

U

SA

29

Car

diac

: Cat

hete

r 24

20

04

GE

RM

AN

Y

C

ardi

ac: C

athe

ter

10

2001

C

AN

AD

A

C

ardi

ac: C

athe

ter

25

1999

U

SA

13

6

C

ardi

ac: C

athe

ter

26

2003

U

SA

C

ardi

ac: C

athe

ter

27

1997

A

US

TRAL

IA

C

ardi

ac: C

athe

ter

9

2004

C

AN

AD

A

C

ardi

ac: C

athe

ter

28

2000

U

SA

C

ardi

ac: C

athe

ter

4 20

04

NEW

ZE

ALA

ND

30

Car

diac

: Cat

hete

r (Ab

latio

n)

29

2001

U

SA

C

ardi

ac: C

athe

ter (

Abla

tion)

4

2004

N

EW Z

EAL

AN

D

C

ardi

ac: C

athe

ter (

Abla

tion)

7

2000

U

SA

C

ardi

ac: C

athe

ter (

Abla

tion)

30

20

04

AU

STR

ALIA

C

ardi

ac: C

athe

ter (

Abla

tion)

31

20

00

US

A

C

ardi

ac: C

athe

ter (

Abla

tion)

32

20

03

AU

STR

ALIA

31

Car

diac

: Cat

hete

r (A

chal

asia

bal

loon

) 24

20

04

GE

RM

AN

Y

32

Car

diac

: Cat

hete

r (An

giog

raph

y)

7 20

00

US

A

C

ardi

ac: C

athe

ter (

Angi

ogra

phy)

9

20

04

CA

NA

DA

C

ardi

ac: C

athe

ter (

Angi

ogra

phy)

3

2003

U

SA

C

ardi

ac: C

athe

ter (

Angi

ogra

phy)

29

20

01

US

A

C

ardi

ac: C

athe

ter (

Angi

ogra

phy)

2

2001

C

AN

AD

A

33

Car

diac

: Cat

hete

r (An

giop

last

y B

allo

ons)

33

19

96

AU

STR

ALIA

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

7 20

00

US

A

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

21

2000

U

SA

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

27

1997

A

US

TRAL

IA

13

7

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

4 20

04

NEW

ZE

ALA

ND

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

24

2004

G

ER

MA

NY

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

2 20

01

CA

NA

DA

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

3 20

03

US

A

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

8 20

00

US

A

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

) 34

20

06

ITA

LY

34

Car

diac

: Cat

hete

r (Ba

lloon

) 25

19

99

US

A

C

ardi

ac: C

athe

ter (

Ballo

on)

35

1999

U

SA

C

ardi

ac: C

athe

ter (

Ballo

on)

7 20

00

US

A

C

ardi

ac: C

athe

ter (

Ballo

on)

4 20

04

NEW

ZE

ALA

ND

C

ardi

ac: C

athe

ter (

Ballo

on)

36

2002

E

UR

OP

EAN

UN

ION

C

ardi

ac: C

athe

ter (

Ballo

on)

3 20

03

US

A

35

Car

diac

: Cat

hete

r (C

ontra

st A

gent

) 24

20

04

GE

RM

AN

Y

36

Car

diac

: Cat

hete

r (E

lect

rode

Rec

ordi

ng)

3 20

03

US

A

C

ardi

ac: C

athe

ter (

Ele

ctro

de R

ecor

ding

) 37

19

97

AU

STR

ALIA

37

Car

diac

: Cat

hete

r (E

lect

roph

ysio

logy

/EP

) 21

20

00

US

A

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

7 20

00

US

A

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

2 20

01

CA

NA

DA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

31

2000

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

23

2003

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

8 20

00

US

A

13

8

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

38

2003

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

39

2004

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

28

2000

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

32

2003

A

US

TRAL

IA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

29

2001

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

36

2002

E

UR

OP

EAN

UN

ION

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

4 20

04

NEW

ZE

ALA

ND

C

ardi

ac: E

lect

roph

ysio

logi

cal C

athe

ter

40

2001

U

SA

38

Car

diac

: Cat

hete

r (Fi

ber-o

ptic

Oxi

met

er)

3 20

03

US

A

39

Car

diac

: Cat

hete

r (G

uide

wire

) 3

2003

U

SA

C

ardi

ac: C

athe

ter (

Gui

dew

ire)

1 19

99

DE

NM

AR

K

C

ardi

ac: C

athe

ter (

Gui

dew

ire)

7 20

00

US

A

C

ardi

ac: C

athe

ter (

Gui

dew

ire)

41

2003

E

UR

OP

EAN

UN

ION

C

ardi

ac: C

athe

ter (

Gui

dew

ire)

35

1999

U

SA

C

ardi

ac: C

athe

ter (

Gui

dew

ire)

10

2001

C

AN

AD

A

C

ardi

ac: C

athe

ter (

Gui

dew

ire)

18

1999

E

UR

OP

EAN

UN

ION

C

ardi

ac: C

athe

ter (

Gui

dew

ire)

2 20

01

CA

NA

DA

40

Car

diac

: Cat

hete

r (H

aem

o-di

alys

is)

29

2001

U

SA

41

Car

diac

: Cat

hete

r (H

igh

Den

sity

Arra

y)

3 20

03

US

A

42

Car

diac

: Cat

hete

r 18

19

99

EU

RO

PEA

N U

NIO

N

43

Car

diac

: Cat

hete

r (Ke

rato

me)

3

2003

U

SA

13

9

44

Car

diac

: Cat

hete

r (St

eera

ble)

3

2003

U

SA

45

Car

diac

: Con

cent

ric N

eedl

es (E

P)

2 20

01

CA

NA

DA

46

Car

diac

: Def

ibril

lato

rs (I

mpl

anta

ble)

42

19

99

EU

RO

PEA

N U

NIO

N

C

ardi

ac: D

efib

rilla

tors

(Im

plan

tabl

e)

24

2004

G

ER

MA

NY

47

Car

diac

: Ext

erna

l Vei

n S

tripp

er

3 20

03

US

A

48

Car

diac

: Pac

emak

er

10

2001

C

AN

AD

A

C

ardi

ac: P

acem

aker

24

20

04

GE

RM

AN

Y

C

ardi

ac: P

acem

aker

2

2001

C

AN

AD

A

C

ardi

ac: P

acem

aker

43

19

98

EU

RO

PEA

N U

NIO

N

C

ardi

ac: P

acem

aker

29

20

01

US

A

C

ardi

ac: P

acem

aker

44

19

96

AU

STR

ALIA

C

ardi

ac: P

acem

aker

45

19

92

CA

NA

DA

C

ardi

ac: P

acem

aker

46

19

85

CA

NA

DA

C

ardi

ac: P

acem

aker

47

19

86

US

A

C

ardi

ac: P

acem

aker

46

19

89

CA

NA

DA

C

ardi

ac: P

acem

aker

48

19

98

SWED

EN

C

ardi

ac: P

acem

aker

49

19

99

CA

NA

DA

C

ardi

ac: P

acem

aker

50

19

78

SWED

EN

49

Car

diac

: Sta

biliz

er D

evic

e 3

2003

U

SA

50

Car

diac

: Syr

inge

3

2003

U

SA

C

ardi

ac: S

yrin

ge

7 20

00

US

A

14

0

51

Car

diac

: Syr

inge

(In

ject

or T

ype

Act

uato

r) 3

2003

U

SA

52

Car

diac

: Syr

inge

(Ang

iogr

aphe

r Inj

ecto

r) 3

2000

U

SA

53

Car

diac

: Tra

cers

39

20

04

US

A

54

Car

diac

: Tra

nsdu

cer

10

2001

C

AN

AD

A

C

ardi

ac: T

rans

duce

r 2

2001

C

AN

AD

A

55

Car

diac

: Tro

car

3 20

03

US

A

C

ardi

ac: T

roca

r 7

2000

U

SA

56

Car

diac

: Vei

n S

tripp

er

3 20

03

US

A

57

Car

diac

: Wire

s 25

19

99

US

A

C

ardi

ac: W

ires

35

1999

U

SA

58

Col

orec

tal:

Man

omet

ry T

ubin

g

2 20

01

CA

NA

DA

59

Col

orec

tal:

Sna

res

51

1996

A

US

TRAL

IA

C

olor

ecta

l: S

nare

s 33

19

96

AU

STR

ALIA

60

Der

mat

olog

y: E

lect

roca

uter

y tip

(hyf

reca

tor)

2 20

01

CA

NA

DA

61

Dia

ther

my:

Ele

ctro

des

21

2000

U

SA

D

iath

erm

y: E

lect

rode

s 8

2000

U

SA

D

iath

erm

y: E

lect

rode

s 7

2000

U

SA

62

Dia

ther

my:

Pen

cils

7

2000

U

SA

D

iath

erm

y: P

enci

ls

33

1996

A

US

TRAL

IA

D

iath

erm

y: P

enci

ls

8 20

00

US

A

D

iath

erm

y: P

enci

ls

3 20

03

US

A

14

1

D

iath

erm

y: P

enci

ls

32

2003

A

US

TRAL

IA

D

iath

erm

y: P

enci

ls

3 20

03

US

A

D

iath

erm

y: P

enci

ls

3 20

03

US

A

63

Ele

ctro

de C

able

3

2003

U

SA

64

Ele

ctro

de: P

ercu

tane

ous

Abl

atio

n 3

2003

U

SA

65

Ele

ctro

des

1 19

99

DE

NM

AR

K

66

Ele

ctro

des

and

need

les:

EEG

10

20

01

CA

NA

DA

E

lect

rode

s an

d ne

edle

s: E

EG

33

1996

A

US

TRAL

IA

E

lect

rode

s an

d ne

edle

s: E

EG

18

1999

E

UR

OP

EAN

UN

ION

67

Ele

ctro

des:

Car

diac

pac

ing

33

19

96

AU

STR

ALIA

E

lect

rode

s: C

ardi

ac p

acin

g

32

2003

A

US

TRAL

IA

E

lect

rode

s: C

ardi

ac p

acin

g

51

1996

A

US

TRAL

IA

68

Ele

ctro

des:

Res

ecto

scop

e

24

2004

G

ER

MA

NY

69

Ele

ctro

des:

Silv

er

52

2002

E

UR

OP

EAN

UN

ION

70

Ele

ctro

phys

iolo

gica

l stim

ulat

ion

30

20

04

AU

STR

ALIA

71

Ele

ctro

phys

iolo

gy: E

EG N

eedl

e-B

onne

t 2

2001

C

AN

AD

A

72

End

osco

pe

3 20

03

US

A

E

ndos

cope

7

2000

U

SA

E

ndos

cope

53

20

04

US

A

E

ndos

cope

1

1999

D

EN

MA

RK

E

ndos

cope

54

20

01

US

A

14

2

E

ndos

cope

55

20

03

CA

NA

DA

E

ndos

cope

56

20

05

JAP

AN

E

ndos

cope

57

20

00

US

A

73

End

osco

py: B

allo

ons

2

2001

C

AN

AD

A

74

End

osco

py: B

lade

s 7

2000

U

SA

E

ndos

copy

: Bla

des

3 20

03

US

A

75

End

osco

py: C

lip A

pplie

r 36

20

02

EU

RO

PEA

N U

NIO

N

76

End

osco

py: G

uide

wire

s 7

2000

U

SA

E

ndos

copy

: Gui

dew

ires

3 20

03

US

A

77

End

osco

py: R

etro

grad

e C

hola

ngio

panc

reat

ogra

phy

51

19

96

AU

STR

ALIA

78

End

osco

py: S

ciss

ors

39

2004

U

SA

79

End

osco

py: S

utur

es

1 19

99

DE

NM

AR

K

80

EN

T: B

urr

58

2004

U

SA

E

NT:

Bur

r 3

2003

U

SA

81

EN

T: C

athe

ter

7 20

00

US

A

E

NT:

Cat

hete

r 3

2003

U

SA

82

EN

T: C

athe

ter (

Trac

heob

ronc

hial

) 7

2000

U

SA

E

NT:

Cat

hete

r (Tr

ache

obro

nchi

al)

3 20

03

US

A

83

EN

T: T

roca

r 58

20

04

US

A

84

Fasc

ia H

olde

rs

7 20

00

US

A

85

Fem

osto

ps

23

2003

U

SA

14

3

86

Fibr

eopt

ic L

aser

Cab

le

3 20

03

US

A

87

Gas

troen

tero

logy

/ U

rolo

gy: B

iops

y Fo

rcep

s

3 20

03

US

A

G

astro

ente

rolo

gy /

Uro

logy

: Bio

psy

Forc

eps

28

20

00

US

A

88

Gas

troen

tero

logy

/ U

rolo

gy: B

iops

y Fo

rcep

s (E

lect

ric)

3 20

03

US

A

89

Gas

troen

tero

logy

/ U

rolo

gy: B

iops

y In

stru

men

t 3

2003

U

SA

90

Gas

troen

tero

logy

/ U

rolo

gy: B

iops

y Pu

nch:

3

2003

U

SA

91

Gas

troen

tero

logy

: Bal

loon

Dila

tors

: EC

RP

32

20

03

AU

STR

ALIA

92

Gas

troen

tero

logy

: Bal

loon

Dila

tors

: Upp

er E

ndos

copy

32

20

03

AU

STR

ALIA

93

Gas

troen

tero

logy

: Bal

loon

Ext

ract

or

2 20

01

CA

NA

DA

94

Gas

troen

tero

logy

: Bal

loon

sys

tem

for u

teru

s ab

latio

n 24

20

04

GE

RM

AN

Y

95

Gas

troen

tero

logy

: Bio

psy

Forc

eps

(Mic

roev

asiv

e)

2 20

01

CA

NA

DA

96

Gas

troen

tero

logy

: Bio

psy

Forc

eps

(Non

-ele

ctric

al)

58

2004

U

SA

G

astro

ente

rolo

gy: B

iops

y Fo

rcep

s (N

on-e

lect

rical

) 7

2000

U

SA

G

astro

ente

rolo

gy: B

iops

y Fo

rcep

s (N

on-e

lect

rical

) 3

2003

U

SA

97

Gas

troen

tero

logy

: Can

nula

32

20

03

AU

STR

ALIA

98

Gas

troen

tero

logy

: C

athe

ter

(Coa

gula

tion

Ele

ctro

-

hem

osta

tis)

2 20

01

CA

NA

DA

99

Gas

troen

tero

logy

: Cyt

olog

y br

ushe

s

2 20

01

CA

NA

DA

G

astro

ente

rolo

gy: C

ytol

ogy

brus

hes

3

2003

U

SA

G

astro

ente

rolo

gy: C

ytol

ogy

brus

hes

32

20

03

AU

STR

ALIA

100

Gas

troen

tero

logy

: Dila

tion

Bal

loon

s 1

1999

D

EN

MA

RK

14

4

G

astro

ente

rolo

gy: D

ilatio

n B

allo

ons

10

2001

C

AN

AD

A

101

Gas

troen

tero

logy

: Ele

ctro

de (A

ctiv

e EP

) 3

2003

U

SA

102

Gas

troen

tero

logy

: E

lect

rode

(F

lexi

ble

Suct

ion

Coa

gula

tor)

3

2003

US

A

103

Gas

troen

tero

logy

: Ele

ctro

de (L

oop)

2

2001

C

AN

AD

A

104

Gas

troen

tero

logy

: Eso

phag

eal S

tent

2

2001

C

AN

AD

A

105

Gas

troen

tero

logy

: Pol

yp fo

rcep

s 9

20

04

CA

NA

DA

106

Gas

troen

tero

logy

: Sto

ne D

islo

dger

3

2003

U

SA

107

Gas

troen

tero

logy

: Sto

ne R

emov

ing

Bas

kets

32

20

03

AU

STR

ALIA

108

Gen

eral

Sur

gery

: Bio

psy

Bru

sh

3 20

03

US

A

109

Gen

eral

Sur

gery

: Bio

psy

Dev

ice

53

2004

U

SA

G

ener

al S

urge

ry: B

iops

y D

evic

e

3 20

03

US

A

110

Gen

eral

Sur

gery

: Bio

psy

Forc

eps

39

2004

U

SA

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 4

2004

N

EW Z

EAL

AN

D

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 7

2000

U

SA

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 59

20

03

US

A

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 26

20

03

US

A

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 3

2003

U

SA

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 22

20

02

US

A

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 11

20

04

CA

NA

DA

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 41

20

03

EU

RO

PEA

N U

NIO

N

14

5

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 38

20

03

US

A

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 35

19

99

US

A

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 10

20

01

CA

NA

DA

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 24

.

2004

G

ER

MA

NY

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 60

20

00

GE

RM

AN

Y

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 8

2000

U

SA

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 23

20

03

US

A

G

ener

al S

urge

ry: B

iops

y Fo

rcep

s 2

2001

C

AN

AD

A

111

Gen

eral

Sur

gery

: Bio

psy

Forc

eps

(Arte

rial)

30

2004

A

US

TRAL

IA

112

Gen

eral

Sur

gery

: Bio

psy

Nee

dle

7 20

00

US

A

G

ener

al S

urge

ry: B

iops

y N

eedl

e 61

20

04

US

A

113

Gen

eral

Sur

gery

: Bla

des

39

2004

U

SA

114

Gen

eral

Sur

gery

: Chi

sel

3 20

03

US

A

115

Gen

eral

Sur

gery

: Cla

mp

(Vas

cula

r) 3

2003

U

SA

G

ener

al S

urge

ry: C

lam

p (V

ascu

lar)

24

2004

G

ER

MA

NY

116

Gen

eral

Sur

gery

: Cla

mp

hold

er

24

2004

G

ER

MA

NY

117

Gen

eral

Sur

gery

: Clip

58

20

04

US

A

G

ener

al S

urge

ry: C

lip

24

2004

G

ER

MA

NY

118

Gen

eral

Sur

gery

: Clip

(Im

plan

tabl

e)

3 20

03

US

A

119

Gen

eral

Sur

gery

: Clip

App

lier

52

2002

E

UR

OP

EAN

UN

ION

120

Gen

eral

Sur

gery

: Clip

Rem

over

s 62

20

04

UK

14

6

G

ener

al S

urge

ry: C

lip R

emov

ers

63

2004

U

K

121

Gen

eral

Sur

gery

: Cut

ting

Acc

esso

ries

7 20

00

US

A

122

Gen

eral

Sur

gery

: Der

mat

ome

3

2003

U

SA

123

Gen

eral

Sur

gery

: Dis

sect

or

3 20

03

US

A

124

Gen

eral

Sur

gery

: Dra

pes

(Unu

sed)

7

2000

U

SA

125

Gen

eral

Sur

gery

: Dril

l Bit

3

2003

U

SA

126

Gen

eral

Sur

gery

: Ext

ract

or

9

2004

C

AN

AD

A

G

ener

al S

urge

ry: E

xtra

ctor

7

2000

U

SA

G

ener

al S

urge

ry: E

xtra

ctor

3

2003

U

SA

127

Gen

eral

Sur

gery

: Hem

osta

tic C

lip A

pplie

r 3

2003

U

SA

128

Gen

eral

Sur

gery

: Hoo

k

3 20

03

US

A

129

Gen

eral

Sur

gery

: Kni

fe

3 20

03

US

A

G

ener

al S

urge

ry: K

nife

32

20

03

AU

STR

ALIA

130

Gen

eral

Sur

gery

: Ost

eoto

me

3

2003

U

SA

131

Gen

eral

Sur

gery

: Ret

ract

or

3 20

03

US

A

132

Gen

eral

Sur

gery

: Ret

ract

or (C

oppe

r Mal

leab

le)

63

2004

U

K

133

Gen

eral

Sur

gery

: Ret

ract

or (S

penc

er W

ells

) 63

20

04

UK

134

Gen

eral

Sur

gery

: Saw

Bla

des

7 20

00

US

A

135

Gen

eral

Sur

gery

: Sta

ple

(Impl

anta

ble)

3

2003

U

SA

136

Gen

eral

Sur

gery

: Sta

ple

Appl

ier

3 20

03

US

A

137

Gen

eral

Sur

gery

: Sta

ple

Driv

er

3 20

03

US

A

14

7

138

Gen

eral

Sur

gery

: Sta

pler

3

2003

U

SA

G

ener

al S

urge

ry: S

tapl

er

7 20

00

US

A

G

ener

al S

urge

ry: S

tapl

er

39

2004

U

SA

G

ener

al S

urge

ry: S

tapl

er

3 20

03

US

A

139

Gen

eral

Sur

gery

: Sta

pler

(End

osco

pic)

7

2000

U

SA

140

Gen

eral

Sur

gery

: Sta

pler

(Pla

stic

Sur

gery

) 7

2000

U

SA

G

ener

al S

urge

ry: S

tapl

er (P

last

ic S

urge

ry)

3 20

03

US

A

141

Gen

eral

Sur

gery

: Suc

tion

Tubi

ng

7 20

00

US

A

142

Gen

eral

Sur

gery

: Sut

ures

(non

-ste

rile)

7

2000

U

SA

G

ener

al S

urge

ry: S

utur

es (n

on-s

teril

e)

22

2002

U

SA

143

Gen

eral

Sur

gery

: Sut

ures

(Sto

mac

h / I

ntes

tinal

) 3

2003

U

SA

144

Gen

eral

Sur

gery

: Tro

car

3 20

03

US

A

G

ener

al S

urge

ry: T

roca

r 4

2004

N

EW Z

EAL

AN

D

G

ener

al S

urge

ry: T

roca

r 38

20

03

US

A

G

ener

al S

urge

ry: T

roca

r 18

19

99

EU

RO

PEA

N U

NIO

N

G

ener

al S

urge

ry: T

roca

r 23

20

03

US

A

G

ener

al S

urge

ry: T

roca

r 24

20

04

GE

RM

AN

Y

G

ener

al S

urge

ry: T

roca

r 39

20

04

US

A

G

ener

al S

urge

ry: T

roca

r 7

2000

U

SA

145

Gen

eral

: Ant

i DV

T ga

rmen

ts

7 20

00

US

A

G

ener

al: A

nti D

VT

garm

ents

28

20

01

US

A

14

8

G

ener

al: A

nti D

VT

garm

ents

39

20

04

US

A

G

ener

al: A

nti D

VT

garm

ents

3

2003

U

SA

G

ener

al: A

nti D

VT

garm

ents

53

20

04

US

A

146

Gen

eral

: Blo

od la

ncet

3

2003

U

SA

147

Gen

eral

: Blo

od P

ress

ure

Cuf

fs

53

2004

U

SA

G

ener

al: B

lood

Pre

ssur

e C

uffs

7

2000

U

SA

G

ener

al: B

lood

Pre

ssur

e C

uffs

3

2003

U

SA

G

ener

al: B

lood

Pre

ssur

e C

uffs

39

20

04

US

A

148

Gen

eral

: Bow

ls

63

2004

U

K

149

Gen

eral

: Bru

shes

1

1999

D

EN

MA

RK

150

Gen

eral

: Cab

les

1

1999

D

EN

MA

RK

151

Gen

eral

: Cat

hete

r 22

20

02

US

A

G

ener

al: C

athe

ter

59

2003

U

SA

G

ener

al: C

athe

ter

52

2002

E

UR

OP

EAN

UN

ION

G

ener

al: C

athe

ter

10

2001

U

SA

G

ener

al: C

athe

ter

24

2004

G

ER

MA

NY

G

ener

al: C

athe

ter

18

1999

E

UR

OP

EAN

UN

ION

G

ener

al: C

athe

ter

51

1996

A

US

TRAL

IA

G

ener

al: C

athe

ter

61

2004

U

SA

152

Gen

eral

: Cat

hete

r (D

iagn

ostic

) 24

20

04

GE

RM

AN

Y

G

ener

al: C

athe

ter (

Dia

gnos

tic)

3 20

03

US

A

14

9

153

Gen

eral

: Cat

hete

r (D

rain

age)

3

2003

U

SA

G

ener

al: C

athe

ter (

Dra

inag

e)

24

2004

G

ER

MA

NY

154

Gen

eral

: Cur

ette

(Sur

gery

) 3

2003

U

SA

155

Gen

eral

: Cut

ting

Equi

pmen

t 1

1999

D

EN

MA

RK

156

Gen

eral

: Syr

inge

64

20

03

UK

G

ener

al: S

yrin

ge

18

1999

E

UR

OP

EAN

UN

ION

G

ener

al: S

yrin

ge

61

2004

U

SA

157

Gen

eral

: Syr

inge

(Irri

gatin

g)

3 20

03

US

A

G

ener

al: S

yrin

ge (I

rriga

ting)

7

2000

U

SA

158

Gen

eral

: Syr

inge

(Pis

ton)

3

2003

U

SA

159

Gen

eral

: Tis

sue

Forc

eps

30

2004

A

US

TRAL

IA

160

Gen

eral

: Tou

rniq

uet

3 20

03

US

A

161

Gen

eral

: Tub

es

1 19

99

DE

NM

AR

K

G

ener

al: T

ubes

19

20

00

UK

162

Glo

ves

64

2003

U

K

163

Gou

ge (S

urge

ry)

3 20

03

US

A

164

Gow

ns

7 20

00

US

A

G

owns

3

2003

U

SA

165

Hem

odia

lysi

s B

lood

Circ

uit

3 20

03

US

A

H

emod

ialy

sis

Blo

od C

ircui

t 7

2000

U

SA

H

emod

ialy

sis

Blo

od C

ircui

t 65

20

05

US

A

15

0

H

emod

ialy

sis

Blo

od C

ircui

t 66

19

97

US

A

H

emod

ialy

sis

Blo

od C

ircui

t 67

19

96

US

A

166

Hem

orrh

oida

l Lig

ator

3

2003

U

SA

167

Hos

es

24

2004

G

ER

MA

NY

168

IAB

dev

ice

4 20

04

NEW

ZE

ALA

ND

169

Impl

ants

1

1999

D

EN

MA

RK

170

Infla

tion

Dev

ices

23

20

03

US

A

171

Infu

sion

Pum

p 3

2003

U

SA

172

Lapa

rosc

opes

7

2000

U

SA

La

paro

scop

es

2 20

01

CA

NA

DA

La

paro

scop

es

3 20

03

US

A

La

paro

scop

es

38

2003

U

SA

La

paro

scop

es

10

2001

C

AN

AD

A

La

paro

scop

es

51

1996

A

US

TRAL

IA

La

paro

scop

es

7 20

00

US

A

La

paro

scop

es

58

2004

U

SA

La

paro

scop

es

53

2004

U

SA

173

Lapa

rosc

opes

: Bab

cock

2

2001

C

AN

AD

A

174

Lapa

rosc

opes

: Cav

itron

Mic

ro N

eedl

e Ti

p 2

2001

C

AN

AD

A

175

Lapa

rosc

opes

: Cla

mps

39

20

04

US

A

176

Lapa

rosc

opes

: Dis

sect

ing

Hoo

k 2

2001

C

AN

AD

A

15

1

177

Lapa

rosc

opes

: Dis

sect

ors

7 20

00

US

A

La

paro

scop

es: D

isse

ctor

s 39

20

04

US

A

La

paro

scop

es: D

isse

ctor

s 3

2003

U

SA

La

paro

scop

es: D

isse

ctor

s

7 20

00

US

A

La

paro

scop

ic d

isse

ctio

n 68

20

02

GE

RM

AN

Y

178

Lapa

rosc

opes

: For

ceps

39

20

04

US

A

La

paro

scop

es: F

orce

ps

32

2003

A

US

TRAL

IA

179

Lapa

rosc

opes

: Gra

sper

s 7

2000

U

SA

La

paro

scop

es: G

rasp

ers

39

2004

U

SA

La

paro

scop

es: G

rasp

ers

3

2003

U

SA

180

Lapa

rosc

opes

: Sci

ssor

s 7

2000

U

SA

La

paro

scop

es: S

ciss

ors

21

2000

U

SA

La

paro

scop

es: S

ciss

ors

38

2003

U

SA

La

paro

scop

es: S

ciss

ors

2 20

01

CA

NA

DA

La

paro

scop

es: S

ciss

ors

51

1996

A

US

TRAL

IA

La

paro

scop

es: S

ciss

ors

8 20

00

US

A

La

paro

scop

es: S

ciss

ors

9

2004

C

AN

AD

A

La

paro

scop

es: S

ciss

ors

39

2004

U

SA

La

paro

scop

es: S

ciss

ors

32

2003

A

US

TRAL

IA

La

paro

scop

es: S

ciss

ors

3 20

03

US

A

181

Lapa

rosc

opes

: Tro

car

2 20

01

CA

NA

DA

15

2

182

Lase

r Fib

re D

eliv

ery

Sys

tem

s 7

2000

U

SA

183

Mec

hani

cal W

rist

3 20

03

US

A

184

Nee

dle

3 20

03

US

A

N

eedl

e 58

20

04

US

A

185

Nee

dle

Des

truct

ion

Dev

ice

3

2003

U

SA

186

Nee

dle

Hol

der

3

2003

U

SA

N

eedl

e H

olde

r 63

20

04

UK

187

Nee

dle:

Ang

iogr

aphi

c 3

2003

U

SA

188

Nee

dle:

Arte

rial C

athe

ter

9

2004

C

AN

AD

A

189

Nee

dle:

Asp

iratio

n an

d In

ject

ion

3

2003

U

SA

N

eedl

e: A

spira

tion

and

Inje

ctio

n 58

20

04

US

A

190

Nee

dle:

Ass

iste

d R

epro

duct

ion

3 20

03

US

A

191

Nee

dle:

Bio

psy

30

20

04

AU

STR

ALIA

N

eedl

e: B

iops

y

10

2001

C

AN

AD

A

N

eedl

e: B

iops

y

26

2003

U

SA

N

eedl

e: B

iops

y

25

1999

U

SA

N

eedl

e: B

iops

y

58

2004

U

SA

N

eedl

e: B

iops

y

7 20

00

US

A

N

eedl

e: B

iops

y

3 20

03

US

A

192

Nee

dle:

Car

diov

ascu

lar

7 20

00

US

A

193

Nee

dle:

Cat

hete

r 58

20

04

US

A

15

3

194

Nee

dle:

Con

duct

ion

3 20

03

US

A

195

Nee

dle:

Ele

ctro

phys

iolo

gica

l (E

P)

10

2001

C

AN

AD

A

N

eedl

e: E

lect

roph

ysio

logi

cal (

EP

) 33

19

96

AU

STR

ALIA

N

eedl

e: E

lect

roph

ysio

logi

cal (

EP

) 18

19

99

EU

RO

PEA

N U

NIO

N

196

Nee

dle:

Hyp

oder

mic

Sin

gle

Lum

en

3 20

03

US

A

197

Nee

dle:

Isot

ope

3

2003

U

SA

198

Nee

dle:

Liv

er b

iops

y

10

2001

C

AN

AD

A

N

eedl

e: L

iver

bio

psy

2

2001

C

AN

AD

A

199

Nee

dle:

Par

acen

tesi

s

2 20

01

CA

NA

DA

200

Nee

dle:

Pha

ecom

ulsi

ficat

ion

7 20

00

US

A

N

eedl

e: P

haec

omul

sific

atio

n

3 20

03

US

A

201

Nee

dle:

Pne

umpe

riton

eum

3

2003

U

SA

202

Nee

dle:

Scl

erot

hera

py

10

2001

C

AN

AD

A

N

eedl

e: S

cler

othe

rapy

2

2001

C

AN

AD

A

N

eedl

e: S

cler

othe

rapy

32

20

03

AU

STR

ALIA

203

Nee

dle:

Sho

rt-te

rm S

pina

l 3

2003

U

SA

204

Nee

dle:

Sin

gle

Lum

en

3 20

03

US

A

205

Nee

dle:

Ste

reot

actic

2

2001

C

AN

AD

A

206

Ner

ve H

ooks

63

20

04

UK

207

Neu

rosu

rger

y: B

iops

y N

eedl

e 32

20

03

AU

STR

ALIA

208

Neu

rosu

rger

y: B

iops

y To

ol

10

2001

C

AN

AD

A

15

4

209

Neu

rosu

rger

y: B

urrs

3

2003

U

SA

210

Neu

rosu

rger

y: C

lip

3 20

03

US

A

211

Neu

rosu

rger

y: D

rills

3

2003

U

SA

212

Neu

rosu

rger

y: T

reph

ines

3

2003

U

SA

213

OB

/GYN

: Bio

psy

Forc

eps

58

2004

U

SA

214

OB

/GYN

: Cul

dosc

opic

Coa

gula

tor

3 20

03

US

A

215

OB

/GYN

: End

osco

pic

Bip

olar

Coa

gula

tor

3 20

03

US

A

216

OB

/GYN

: End

osco

pic

Uni

pola

r Coa

gula

tor

3 20

03

US

A

217

OB

/GYN

: Hys

tero

scop

ic C

oagu

lato

r 3

2003

U

SA

218

OB

/GYN

: Lap

aros

cope

s

3 20

03

US

A

219

OB

/GYN

: Tro

car

7 20

00

US

A

220

Ope

ned

but u

sed

item

s 39

20

04

US

A

221

Oph

thal

mic

: Bla

de (K

erat

ome)

3

2003

U

SA

O

phth

alm

ic: B

lade

(Ker

atom

e)

7 20

00

US

A

222

Oph

thal

mic

: End

o-illu

min

ator

3

2003

U

SA

223

Oph

thal

mic

: Kni

fe

3 20

03

US

A

O

phth

alm

ic: K

nife

58

20

04

US

A

224

Orth

opae

dic:

Bla

de (C

arpa

l Tun

nel)

3

2003

U

SA

O

rthop

aedi

c: B

lade

(Car

pal T

unne

l)

7 20

00

US

A

225

Orth

opae

dic:

Ans

patc

h Ti

p

2 20

01

CA

NA

DA

226

Orth

opae

dic:

Arth

osco

pic

Acc

esso

ries

3

2003

U

SA

15

5

227

Orth

opae

dic:

Arth

osco

pic

shav

ers

& w

ands

38

20

03

US

A

O

rthop

aedi

c: A

rthos

copi

c w

ands

23

20

03

US

A

228

Orth

opae

dic:

Arth

rosc

opic

Inst

rum

ents

24

20

04

GE

RM

AN

Y

O

rthop

aedi

c: A

rthro

scop

ic in

stru

men

ts

7 20

00

US

A

229

Orth

opae

dic:

Arth

rosc

opic

sha

ver b

lade

s 24

20

04

GE

RM

AN

Y

230

Orth

opae

dic:

Arth

rosc

opic

Sha

vers

39

20

04

US

A

231

Orth

opae

dic:

Bla

des

23

20

03

US

A

232

Orth

opae

dic:

Bon

e H

ook

(Sur

gery

) 3

2003

U

SA

233

Orth

opae

dic:

Bon

e Ta

p

3 20

03

US

A

234

Orth

opae

dic:

Bon

e-m

arro

w tr

ephi

ne s

ets

51

1996

A

US

TRAL

IA

235

Orth

opae

dic:

Bur

r

3 20

03

US

A

O

rthop

aedi

c: B

urr

23

20

03

US

A

O

rthop

aedi

c: B

urr

7

2000

U

SA

O

rthop

aedi

c: B

urr

39

20

04

US

A

O

rthop

aedi

c: B

urr

53

20

04

US

A

236

Orth

opae

dic:

Cou

nter

sink

3

2003

U

SA

237

Orth

opae

dic:

Dril

l Bit

3 20

03

US

A

O

rthop

aedi

c: D

rill B

it

7 20

00

US

A

O

rthop

aedi

c: D

rill B

it

39

2004

U

SA

O

rthop

aedi

c: D

rill B

it

61

2004

U

SA

O

rthop

aedi

c: D

rill B

it

7 20

00

US

A

15

6

O

rthop

aedi

c: D

rill B

it

21

2000

U

SA

O

rthop

aedi

c: D

rill B

it

8 20

00

US

A

238

Orth

opae

dic:

Dril

ls (F

lexi

ble)

3

2003

U

SA

239

Orth

opae

dic:

Ext

erna

l Fix

atio

n D

evic

e 38

20

03

US

A

O

rthop

aedi

c: E

xter

nal F

ixat

ion

Dev

ice

39

2004

U

SA

O

rthop

aedi

c: E

xter

nal F

ixat

ion

Dev

ice

4 20

04

NEW

ZE

ALA

ND

O

rthop

aedi

c: E

xter

nal F

ixat

ion

Dev

ice

7 20

00

US

A

O

rthop

aedi

c: E

xter

nal F

ixat

ion

Dev

ice

3 20

03

US

A

O

rthop

aedi

c: E

xter

nal f

ixat

or

69

2006

U

SA

240

Orth

opae

dic:

Fle

xibl

e R

eam

ers

/ Dril

ls

7 20

00

US

A

241

Orth

opae

dic:

Ful

l Rad

ius

Tip

2 20

01

CA

NA

DA

242

Orth

opae

dic:

Hip

Joi

nt

3 20

03

US

A

O

rthop

aedi

c: H

ip J

oint

24

20

04

GE

RM

AN

Y

243

Orth

opae

dic:

Impl

ants

2

2001

C

AN

AD

A

244

Orth

opae

dic:

Kne

e Jo

int

3 20

03

US

A

O

rthop

aedi

c: K

nee

Join

t 24

20

04

GE

RM

AN

Y

245

Orth

opae

dic:

Kni

fe

3 20

03

US

A

246

Orth

opae

dic:

Ras

p

3 20

03

US

A

247

Orth

opae

dic:

Rea

mer

3

2003

U

SA

O

rthop

aedi

c: R

eam

er

30

2004

A

US

TRAL

IA

O

rthop

aedi

c: R

eam

er

10

2001

C

AN

AD

A

15

7

248

Orth

opae

dic:

Sho

ulde

r Joi

nt

3 20

03

US

A

249

Orth

opae

dic:

Tre

phin

e

3 20

03

US

A

250

Orth

opae

dics

: Ron

geur

3

2003

U

SA

251

Pel

visc

ope

24

2004

G

ER

MA

NY

252

Pha

co T

ips

39

2004

U

SA

253

Pha

cofra

gmen

tatio

n sy

stem

3

2003

U

SA

254

PH

-met

ric e

lect

rode

s 24

20

04

GE

RM

AN

Y

255

Pne

umat

ic T

ourn

ique

t Cuf

fs

39

2004

U

SA

256

Pol

ypec

tom

y sl

ing

24

2004

G

ER

MA

NY

257

Pro

be: A

rgon

pla

sma

coag

ulat

ion

25

19

99

US

A

P

robe

: Arg

on p

lasm

a co

agul

atio

n 4

2004

N

EW Z

EAL

AN

D

258

Pro

bes

/ las

er p

robe

s 24

20

04

GE

RM

AN

Y

259

Pro

bes:

Pac

emak

er

24

2004

G

ER

MA

NY

260

Pro

lene

mes

h 7

2000

U

SA

261

Pro

sthe

sis

1 19

99

DE

NM

AR

K

P

rost

hesi

s 24

20

04

GE

RM

AN

Y

P

rost

hesi

s 38

20

03

US

A

262

PTC

A

53

2004

U

SA

263

Pul

se O

xim

eter

3

2003

U

SA

P

ulse

Oxi

met

er

53

2004

U

SA

264

Pul

se O

xim

eter

Sen

sors

39

20

04

US

A

15

8

P

ulse

Oxi

met

er S

enso

rs

28

2002

U

SA

265

Pum

p ho

ses

24

2004

G

ER

MA

NY

266

PV

B pr

essu

re c

onve

rter

24

2004

G

ER

MA

NY

267

Rad

iolo

gy: B

ile D

uct S

tone

Ext

ract

or

2 20

01

CA

NA

DA

268

Rad

iolo

gy: C

athe

ter

29

2001

U

SA

269

Res

pira

tory

/ P

ulm

onar

y: N

asal

Pro

ngs

2 20

01

CA

NA

DA

270

Res

pira

tory

/ P

ulm

onar

y: T

rach

eost

omy

tubi

ng

2 20

01

CA

NA

DA

271

Saw

53

20

04

US

A

S

aw

3 20

03

US

A

S

aw

39

2004

U

SA

272

Saw

Bla

de

3 20

03

US

A

S

aw B

lade

24

20

04

GE

RM

AN

Y

S

aw B

lade

7

2000

U

SA

S

aw B

lade

61

20

04

US

A

S

aw B

lade

21

20

00

US

A

S

aw B

lade

59

20

03

US

A

S

aw B

lade

8

2000

U

SA

273

Sca

lpel

bla

de

3 20

03

US

A

274

Sci

ssor

Tip

s

7 20

00

US

A

275

Sci

ssor

s 39

20

04

US

A

S

ciss

ors

3

2003

U

SA

15

9

S

ciss

ors

25

19

99

US

A

S

ciss

ors

35

19

99

US

A

S

ciss

ors

64

20

03

UK

S

ciss

ors

26

20

03

US

A

276

Sci

ssor

s Ti

ps

3 20

03

US

A

277

Sha

rps

Con

tain

ers

7 20

00

US

A

278

Sha

ver

24

2004

G

ER

MA

NY

279

Sna

re

3 20

03

US

A

S

nare

39

20

04

US

A

S

nare

10

20

01

CA

NA

DA

S

nare

33

19

96

AU

STR

ALIA

S

nare

2

2001

C

AN

AD

A

S

nare

32

20

03

AU

STR

ALIA

280

Sof

t Tis

sue

Abla

tors

39

20

04

US

A

281

Spa

tula

3

2003

U

SA

282

Sph

inct

erto

me

70

1998

U

SA

S

phin

cter

tom

e 7

2000

U

SA

S

phin

cter

tom

e 10

20

01

CA

NA

DA

S

phin

cter

tom

e 3

2003

U

SA

S

phin

cter

tom

e 53

20

04

US

A

S

phin

cter

tom

e 4

2004

N

EW Z

EAL

AN

D

16

0

S

phin

cter

otom

e 9

20

04

CA

NA

DA

S

phin

cter

tom

es

71

2003

U

SA

S

phin

cter

tom

es

72

1997

U

SA

283

Suc

tion

Scr

ews

24

2004

G

ER

MA

NY

284

Sur

gery

: Cat

hete

r Nee

dle

3

2003

U

SA

285

Syr

inge

Pis

ton

& In

fusi

on Im

plan

ted

Pum

ps

7 20

00

US

A

286

Uro

logy

: D

ialy

sis

Set

3

2003

U

SA

287

Uro

logy

: Cat

hete

r (B

iliary

) 3

2003

U

SA

U

rolo

gy: C

athe

ter (

Bilia

ry)

24

2004

G

ER

MA

NY

288

Uro

logy

: Cat

hete

r (B

ladd

er &

rect

al c

athe

ters

) 24

20

04

GE

RM

AN

Y

289

Uro

logy

: Cat

hete

r (U

reth

ral)

7 20

00

US

A

U

rolo

gy: C

athe

ter (

Ure

thra

l) 2

2001

C

AN

AD

A

U

rolo

gy: C

athe

ter (

Ure

thra

l) 3

2003

U

SA

290

Uro

logy

: Pap

illoto

me

24

20

04

GE

RM

AN

Y

291

Uro

logy

: Pen

ile R

ing

2

2001

C

AN

AD

A

16

1

ii. R

euse

by

coun

try

R

euse

d S

ingl

e U

se D

evic

e R

efer

ence

D

ate

C

ount

ry o

f Orig

in

1 C

ardi

ac: C

athe

ter

27

1997

A

US

TRAL

IA

2 C

ardi

ac: C

athe

ter (

Abla

tion)

30

20

04

AU

STR

ALIA

C

ardi

ac: C

athe

ter (

Abla

tion)

32

20

03

AU

STR

ALIA

3 C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

33

1996

A

US

TRAL

IA

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

27

1997

A

US

TRAL

IA

4 C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

32

2003

A

US

TRAL

IA

5 C

olor

ecta

l: S

nare

s 51

19

96

AU

STR

ALIA

C

olor

ecta

l: S

nare

s 33

19

96

AU

STR

ALIA

6 D

iarth

erm

y: P

enci

ls

32

2003

A

US

TRAL

IA

D

iath

erm

y: P

enci

ls

33

1996

A

US

TRAL

IA

7 E

lect

rode

s an

d ne

edle

s: E

EG

33

1996

A

US

TRAL

IA

8 E

lect

rode

s: C

ardi

ac p

acin

g

33

1996

A

US

TRAL

IA

E

lect

rode

s: C

ardi

ac p

acin

g

32

2003

A

US

TRAL

IA

E

lect

rode

s: C

ardi

ac P

acin

g

51

1996

A

US

TRAL

IA

9 E

lect

roph

ysio

logi

cal s

timul

atio

n

30

2004

A

US

TRAL

IA

10

End

osco

py: R

etro

grad

e C

hola

ngio

panc

reat

ogra

phy

51

19

96

AU

STR

ALIA

11

Gas

troen

tero

logy

: Bal

loon

Dila

tors

: EC

RP

32

20

03

AU

STR

ALIA

12

Gas

troen

tero

logy

: Bal

loon

Dila

tors

: Upp

er E

ndos

copy

32

20

03

AU

STR

ALIA

13

Gas

troen

tero

logy

: Can

nula

32

20

03

AU

STR

ALIA

16

2

14

Gas

troen

tero

logy

: Cyt

olog

y br

ushe

s

32

2003

A

US

TRAL

IA

15

Gas

troen

tero

logy

: Sto

ne R

emov

ing

Bas

kets

32

20

03

AU

STR

ALIA

16

Gen

eral

Sur

gica

l: B

iops

y Fo

rcep

s (A

rteria

l) 30

20

04

AU

STR

ALIA

17

Gen

eral

Sur

gica

l: K

nife

32

20

03

AU

STR

ALIA

18

Gen

eral

: Cat

hete

r 51

19

96

AU

STR

ALIA

19

Gen

eral

: Tis

sue

Forc

eps

30

2004

A

US

TRAL

IA

20

Lapa

rosc

opes

51

19

96

AU

STR

ALIA

21

Lapa

rosc

opes

: For

ceps

32

20

03

AU

STR

ALIA

22

Lapa

rosc

opes

: Sci

ssor

s 51

19

96

AU

STR

ALIA

La

paro

scop

es: S

ciss

ors

32

2003

A

US

TRAL

IA

23

Nee

dle:

Bio

psy

30

20

04

AU

STR

ALIA

24

Nee

dle:

Ele

ctro

phys

iolo

gica

l (E

P)

33

1996

A

US

TRAL

IA

25

Nee

dle:

Scl

erot

hera

py

32

2003

A

US

TRAL

IA

26

Neu

rosu

rger

y: B

iops

y N

eedl

e 32

20

03

AU

STR

ALIA

27

Orth

opae

dic:

Bon

e-m

arro

w tr

ephi

ne s

ets

51

1996

A

US

TRAL

IA

28

Orth

opae

dic:

Rea

mer

30

20

04

AU

STR

ALIA

29

Sna

re

33

1996

A

US

TRAL

IA

S

nare

32

20

03

AU

STR

ALIA

16

3

1 A

mbu

bag

(Neo

nata

l)

2 20

01

CA

NA

DA

2 A

naes

thes

ia: B

ite B

lock

2

2001

C

AN

AD

A

3 A

naes

thes

ia: B

reat

hing

Circ

uits

9

20

04

CA

NA

DA

A

naes

thes

ia: B

reat

hing

Circ

uits

10

20

01

CA

NA

DA

4 A

naes

thes

ia: E

ndot

rach

eal T

ube

10

2001

C

AN

AD

A

A

naes

thes

ia: E

ndot

rach

eal T

ube

2 20

01

CA

NA

DA

5 A

naes

thes

ia: I

ntub

atin

g st

ylet

tes

(bou

gies

) 2

2001

C

AN

AD

A

6 A

naes

thes

ia: N

ebul

iser

s 10

20

01

CA

NA

DA

7 A

naes

thes

ia: O

ral a

irway

s 2

2001

C

AN

AD

A

8 A

naes

thes

ia: T

-pie

ce

2 20

01

CA

NA

DA

9 C

ardi

ac: C

athe

ter

10

2001

C

AN

AD

A

C

ardi

ac: C

athe

ter

9

2004

C

AN

AD

A

10

Car

diac

: Cat

hete

r (An

giog

raph

y)

9

2004

C

AN

AD

A

C

ardi

ac: C

athe

ter (

Angi

ogra

phy)

2

2001

C

AN

AD

A

11

Car

diac

: Cat

hete

r (An

giop

last

y B

allo

ons)

2

2001

C

AN

AD

A

12

Car

diac

: Cat

hete

r (E

lect

roph

ysio

logy

/EP

) 2

2001

C

AN

AD

A

13

Car

diac

: Cat

hete

r (G

uide

wire

) 10

20

01

CA

NA

DA

C

ardi

ac: C

athe

ter (

Gui

dew

ire)

2 20

01

CA

NA

DA

14

Car

diac

: Con

cent

ric N

eedl

es (E

lect

roph

ysio

logy

) 2

2001

C

AN

AD

A

15

Car

diac

: Pac

emak

er

10

2001

C

AN

AD

A

C

ardi

ac: P

acem

aker

2

2001

C

AN

AD

A

16

4

16

Car

diac

: Tra

nsdu

cer

10

2001

C

AN

AD

A

C

ardi

ac: T

rans

duce

r 2

2001

C

AN

AD

A

17

Col

orec

tal:

Man

omet

ry T

ubin

g

2 20

01

CA

NA

DA

18

Der

mat

olog

y: E

lect

roca

uter

y tip

(hyf

reca

tor)

2 20

01

CA

NA

DA

19

Ele

ctro

des

and

need

les:

EEG

10

20

01

CA

NA

DA

E

lect

roph

ysio

logy

: EEG

Nee

dle-

Bon

net

2 20

01

CA

NA

DA

20

End

osco

py: B

allo

ons

2

2001

C

AN

AD

A

21

Gas

troen

tero

logy

: Bal

loon

Ext

ract

or

2 20

01

CA

NA

DA

22

Gas

troen

tero

logy

: Bio

psy

Forc

eps

(Mic

roev

asiv

e)

2 20

01

CA

NA

DA

23

Gas

troen

tero

logy

: C

athe

ter

(Coa

gula

tion

Ele

ctro

-

hem

osta

tis)

2 20

01

CA

NA

DA

24

Gas

troen

tero

logy

: Cyt

olog

y br

ushe

s

2 20

01

CA

NA

DA

25

Gas

troen

tero

logy

: Dila

tion

Bal

loon

s 10

20

01

CA

NA

DA

26

Gas

troen

tero

logy

: Ele

ctro

de (L

oop)

2

2001

C

AN

AD

A

27

Gas

troen

tero

logy

: Eso

phag

eal S

tent

2

2001

C

AN

AD

A

28

Gas

troen

tero

logy

: Pol

yp fo

rcep

s 9

20

04

CA

NA

DA

29

Gen

eral

Sur

gery

: Ext

ract

or

9

2004

C

AN

AD

A

30

Gen

eral

Sur

gica

l: B

iops

y Fo

rcep

s 11

20

04

CA

NA

DA

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

10

2001

C

AN

AD

A

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

2 20

01

CA

NA

DA

31

Lapa

rosc

opes

2

2001

C

AN

AD

A

16

5

La

paro

scop

es

10

2001

C

AN

AD

A

32

Lapa

rosc

opes

: Bab

cock

2

2001

C

AN

AD

A

33

Lapa

rosc

opes

: Cav

itron

Mic

ro N

eedl

e Ti

p 2

2001

C

AN

AD

A

34

Lapa

rosc

opes

: Dis

sect

ing

Hoo

k 2

2001

C

AN

AD

A

35

Lapa

rosc

opes

: Sci

ssor

s 2

2001

C

AN

AD

A

La

paro

scop

es: S

ciss

ors

9

2004

C

AN

AD

A

36

Lapa

rosc

opes

: Tro

car

2 20

01

CA

NA

DA

37

Nee

dle:

Arte

rial C

athe

ter

9

2004

C

AN

AD

A

38

Nee

dle:

Bio

psy

10

20

01

CA

NA

DA

39

Nee

dle:

Ele

ctro

phys

iolo

gica

l (E

P)

10

2001

C

AN

AD

A

40

Nee

dle:

Liv

er b

iops

y

10

2001

C

AN

AD

A

N

eedl

e: L

iver

bio

psy

2

2001

C

AN

AD

A

41

Nee

dle:

Par

acen

tesi

s

2 20

01

CA

NA

DA

42

Nee

dle:

Scl

erot

hera

py

10

2001

C

AN

AD

A

N

eedl

e: S

cler

othe

rapy

2

2001

C

AN

AD

A

43

Nee

dle:

Ste

reot

actic

2

2001

C

AN

AD

A

44

Neu

rosu

rger

y: B

iops

y To

ol

10

2001

C

AN

AD

A

45

Orth

opae

dic:

Ans

patc

h Ti

p

2 20

01

CA

NA

DA

46

Orth

opae

dic:

Ful

l Rad

ius

Tip

2 20

01

CA

NA

DA

47

Orth

opae

dic:

Impl

ants

2

2001

C

AN

AD

A

48

Orth

opae

dic:

Rea

mer

10

20

01

CA

NA

DA

16

6

49

Rad

iolo

gy: B

ile D

uct S

tone

Ext

ract

or

2 20

01

CA

NA

DA

50

Res

pira

tory

/ P

ulm

onar

y: N

asal

Pro

ngs

2 20

01

CA

NA

DA

51

Res

pira

tory

/ P

ulm

onar

y: T

rach

eost

omy

tubi

ng

2 20

01

CA

NA

DA

52

Sna

re

10

2001

C

AN

AD

A

S

nare

2

2001

C

AN

AD

A

53

Sph

inct

erto

me

10

2001

C

AN

AD

A

S

phnc

tero

tom

e 9

20

04

CA

NA

DA

54

Uro

logy

: Cat

hete

r (U

reth

ral)

2 20

01

CA

NA

DA

55

Uro

logy

: Pen

ile R

ing

2

2001

C

AN

AD

A

1 A

graf

Equ

ipm

ent

1 19

99

DE

NM

AR

K

2 A

naes

thes

ia: I

ntub

atio

n E

quip

men

t 1

1999

D

EN

MA

RK

3 A

naes

thes

ia: M

asks

1

1999

D

EN

MA

RK

4 C

ardi

ac: C

athe

ter (

Gui

dew

ire)

1 19

99

DE

NM

AR

K

5 E

lect

rode

s 1

1999

D

EN

MA

RK

6 E

ndos

cope

1

1999

D

EN

MA

RK

7 E

ndos

copy

: Sut

ures

1

1999

D

EN

MA

RK

8 G

astro

ente

rolo

gy: D

ilatio

n B

allo

ons

1 19

99

DE

NM

AR

K

9 G

ener

al: B

rush

es

1 19

99

DE

NM

AR

K

10

Gen

eral

: Cab

les

1

1999

D

EN

MA

RK

11

Gen

eral

: Cut

ting

Equi

pmen

t 1

1999

D

EN

MA

RK

16

7

12

Gen

eral

: Tub

es

1 19

99

DE

NM

AR

K

13

Impl

ants

1

1999

D

EN

MA

RK

14

Pro

sthe

sis

1 19

99

DE

NM

AR

K

1 A

naes

thes

ia: L

MA

s

18

1999

E

UR

OP

EAN

UN

ION

2 A

naes

thes

ia: T

ubin

g 18

19

99

EU

RO

PEA

N U

NIO

N

3 C

ardi

ac: C

athe

ter (

Abla

tion)

29

20

02

EU

RO

PEA

N U

NIO

N

4 C

ardi

ac: C

athe

ter (

Ballo

on)

36

2002

E

UR

OP

EAN

UN

ION

5 C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

41

2000

E

UR

OP

EAN

UN

ION

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

36

2002

E

UR

OP

EAN

UN

ION

6 C

ardi

ac: C

athe

ter (

Gui

dew

ire)

41

2003

E

UR

OP

EAN

UN

ION

7 C

ardi

ac: C

athe

ter

18

1999

E

UR

OP

EAN

UN

ION

8 C

ardi

ac: D

efib

rilla

tors

42

19

99

EU

RO

PEA

N U

NIO

N

9 C

ardi

ac: P

acem

aker

43

19

98

EU

RO

PEA

N U

NIO

N

10

Ele

ctro

des

and

need

les:

EEG

18

19

99

EU

RO

PEA

N U

NIO

N

11

Ele

ctro

des:

Silv

er

52

2002

E

UR

OP

EAN

UN

ION

12

End

osco

py: C

lip A

pplie

r 36

20

02

EU

RO

PEA

N U

NIO

N

13

Gen

eral

Sur

gica

l: B

iops

y Fo

rcep

s 41

20

03

EU

RO

PEA

N U

NIO

N

14

Gen

eral

Sur

gica

l: C

lip A

pplie

r 52

20

02

EU

RO

PEA

N U

NIO

N

15

Gen

eral

Sur

gica

l: Tr

ocar

18

19

99

EU

RO

PEA

N U

NIO

N

16

Gen

eral

: Cat

hete

r 52

20

02

EU

RO

PEA

N U

NIO

N

16

8

17

Gen

eral

: Cat

hete

r (D

iagn

ostic

) 18

19

99

EU

RO

PEA

N U

NIO

N

18

Gen

eral

: Syr

inge

18

19

99

EU

RO

PEA

N U

NIO

N

19

Nee

dle:

Ele

ctro

phys

iolo

gica

l (E

P)

18

1999

E

UR

OP

EAN

UN

ION

1 C

ardi

ac: C

athe

ter

24

2004

G

ER

MA

NY

2 C

ardi

ac: C

athe

ter (

Ach

alas

ia b

allo

on)

24

2004

G

ER

MA

NY

3 C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

24

2004

G

ER

MA

NY

4 C

ardi

ac: C

athe

ter (

Con

trast

Age

nt)

24

2004

G

ER

MA

NY

5 C

ardi

ac: D

efib

rilla

tors

(Im

plan

tabl

e)

24

2004

G

ER

MA

NY

6 C

ardi

ac: P

acem

aker

24

20

04

GE

RM

AN

Y

7 E

lect

rode

s: R

esec

tosc

ope

24

20

04

GE

RM

AN

Y

8 G

astro

ente

rolo

gy: B

allo

on s

yste

m fo

r ute

rus

abla

tion

24

2004

G

ER

MA

NY

9 G

ener

al S

urgi

cal C

lam

p (V

ascu

lar)

24

2004

G

ER

MA

NY

10

Gen

eral

Sur

gica

l: B

iops

y Fo

rcep

s 24

20

04

GE

RM

AN

Y

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

60

2000

G

ER

MA

NY

11

Gen

eral

Sur

gica

l: C

lam

p ho

lder

24

20

04

GE

RM

AN

Y

12

Gen

eral

Sur

gica

l: C

lips

24

2004

G

ER

MA

NY

13

Gen

eral

Sur

gica

l: Tr

ocar

24

20

04

GE

RM

AN

Y

14

Gen

eral

: Cat

hete

r 24

20

04

GE

RM

AN

Y

15

Gen

eral

: Cat

hete

r (D

iagn

ostic

) 24

20

04

GE

RM

AN

Y

16

Gen

eral

: Cat

hete

r (D

rain

age)

24

20

04

GE

RM

AN

Y

16

9

17

Hos

es

24

2004

G

ER

MA

NY

18

Orth

opae

dic:

Arth

rosc

opic

Inst

rum

ents

24

20

04

GE

RM

AN

Y

19

Orth

opae

dic:

Arth

rosc

opic

sha

ver b

lade

s 24

20

04

GE

RM

AN

Y

20

Orth

opae

dic:

Hip

Joi

nt

24

2004

G

ER

MA

NY

21

Orth

opae

dic:

Kne

e Jo

int

24

2004

G

ER

MA

NY

22

Pel

visc

ope

24

2004

G

ER

MA

NY

23

PH

-met

ric e

lect

rode

s 24

20

04

GE

RM

AN

Y

24

Pol

ypec

tom

y sl

ing

24

2004

G

ER

MA

NY

25

Pro

bes

/ las

er p

robe

s 24

20

04

GE

RM

AN

Y

26

Pro

bes:

Pac

emak

er

24

2004

G

ER

MA

NY

27

Pro

sthe

sis

24

2004

G

ER

MA

NY

28

Pum

p ho

ses

24

2004

G

ER

MA

NY

29

PV

B pr

essu

re c

onve

rter

24

2004

G

ER

MA

NY

30

Saw

Bla

de

24

2004

G

ER

MA

NY

31

Sha

ver

24

2004

G

ER

MA

NY

32

Suc

tion

Scr

ews

24

2004

G

ER

MA

NY

33

Uro

logy

: Cat

hete

r (B

iliary

) 24

20

04

GE

RM

AN

Y

34

Uro

logy

: Cat

hete

r (B

ladd

er &

rect

al c

athe

ters

) 24

20

04

GE

RM

AN

Y

35

Uro

logy

: Pap

illoto

me

24

20

04

GE

RM

AN

Y

17

0

1 A

naes

thes

ia: A

irway

Dev

ice

4 20

04

NEW

ZE

ALA

ND

2 A

naes

thes

ia: B

ronc

hosc

ope

4 20

04

NEW

ZE

ALA

ND

3 A

naes

thes

ia: F

ilter

4

2004

N

EW Z

EAL

AN

D

4 A

ngio

scop

e 4

2004

N

EW Z

EAL

AN

D

5 C

ardi

ac: C

athe

ter

4 20

04

NEW

ZE

ALA

ND

6 C

ardi

ac: C

athe

ter (

Abla

tion)

4

2004

N

EW Z

EAL

AN

D

7 C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

4 20

04

NEW

ZE

ALA

ND

8 C

ardi

ac: C

athe

ter (

Ballo

on)

4 20

04

NEW

ZE

ALA

ND

9 C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

4 20

04

NEW

ZE

ALA

ND

10

Gen

eral

Sur

gica

l: B

iops

y Fo

rcep

s 4

2004

N

EW Z

EAL

AN

D

11

Gen

eral

Sur

gica

l: Tr

ocar

4

2004

N

EW Z

EAL

AN

D

12

IAB

dev

ice

4 20

04

NEW

ZE

ALA

ND

13

Orth

opae

dic:

Ext

erna

l Fix

atio

n D

evic

e 4

2004

N

EW Z

EAL

AN

D

14

Pro

be: A

rgon

Pla

sma

Coa

gula

tion

4 20

04

NEW

ZE

ALA

ND

15

Sph

inct

erto

me

4 20

04

NEW

ZE

ALA

ND

1 A

naes

thes

ia: A

ngle

pie

ce c

onne

ctor

in P

CB

6

2004

U

K

2 A

naes

thes

ia: C

athe

ter m

ount

on

PC

B

12

2004

U

K

A

naes

thes

ia: C

athe

ter m

ount

on

PC

B

13

2002

U

K

3 A

naes

thes

ia: F

ilter

14

20

04

UK

A

naes

thes

ia: F

ilter

15

20

01

UK

17

1

4 A

naes

thes

ia: L

aryn

gosc

ope

blad

es

16

2002

U

K

5 A

naes

thes

ia: L

MA

s

17

2000

U

K

6 A

naes

thes

ia: M

asks

19

20

00

UK

7 A

naes

thes

ia: N

ebul

iser

s 14

20

04

UK

8 A

naes

thes

ia: S

prio

met

y Tu

bing

20

20

04

UK

9 A

naes

thes

ia: S

traig

ht T

ada

pter

(PC

B)

12

2004

U

K

A

naes

thes

ia: S

traig

ht T

ada

pter

(PC

B)

13

2004

U

K

10

Ana

esth

esia

: Tub

ing

17

2000

U

K

11

Gen

eral

Sur

gica

l: C

lip R

emov

ers

62

2004

U

K

G

ener

al S

urgi

cal:

Clip

Rem

over

s 63

20

04

UK

12

Gen

eral

Sur

gica

l: R

etra

ctor

(Cop

per M

alle

able

) 63

20

04

UK

13

Gen

eral

Sur

gica

l: R

etra

ctor

(Spe

ncer

Wel

ls)

63

2004

U

K

14

Gen

eral

: Bow

ls

63

2004

U

K

15

Gen

eral

: Syr

inge

64

20

03

UK

16

Gen

eral

: Tub

es

19

2000

U

K

17

Glo

ves

64

2003

U

K

18

Nee

dle

Hol

der

63

2004

U

K

19

Ner

ve H

ooks

63

20

04

UK

20

Sci

ssor

s

64

2003

U

K

17

2

1 A

naes

thes

ia: M

asks

7

2000

U

SA

A

naes

thes

ia: M

asks

3

2003

U

SA

A

naes

thes

ia: M

asks

2

2001

U

SA

2 A

naes

thes

ia: M

outh

piec

es

3 20

03

US

A

A

naes

thes

ia: M

outh

piec

es

7 20

00

US

A

3 A

naes

thes

ia: R

espi

rato

ry T

hera

py

7 20

00

US

A

4 A

naes

thes

ia: A

irway

Con

nect

or

3 20

03

US

A

5 A

naes

thes

ia: B

reat

hing

Circ

uits

7

2000

U

SA

A

naes

thes

ia: B

reat

hing

Circ

uits

8

2000

U

SA

A

naes

thes

ia: B

reat

hing

Circ

uits

3

2003

U

SA

A

naes

thes

ia: B

reat

hing

Circ

uits

11

20

04

US

A

A

naes

thes

ia: B

reat

hing

Circ

uits

2

2001

U

SA

6 A

naes

thes

ia: B

ronc

hosc

ope

3 20

03

US

A

A

naes

thes

ia: B

ronc

hosc

ope

3 20

03

US

A

7 A

naes

thes

ia: E

ndot

rach

eal T

ube

3 20

03

US

A

A

naes

thes

ia: E

ndot

rach

eal T

ube

8 20

00

US

A

A

naes

thes

ia: E

ndot

rach

eal T

ube

7 20

00

US

A

8 A

naes

thes

ia: F

ilter

21

20

00

US

A

9 A

naes

thes

ia::

Oxy

gena

tors

22

20

02

US

A

10

Ant

i DV

T ga

rmen

ts

28

2001

U

SA

A

nti D

VT

garm

ents

39

20

04

US

A

17

3

11

Bio

psy

need

le

61

2004

U

SA

12

Car

diac

: Aor

tic p

unch

es

23

2003

U

SA

13

Car

diac

: Bal

loon

s 25

19

99

US

A

C

ardi

ac: B

allo

ons

35

19

99

US

A

14

Car

diac

: Bio

psy

Nee

dle

3 20

03

US

A

15

Car

diac

: Bur

r 3

2003

U

SA

16

Car

diac

: Cat

hete

r 25

19

99

US

A

C

ardi

ac: C

athe

ter

26

2003

U

SA

C

ardi

ac: C

athe

ter

28

2000

U

SA

17

Car

diac

: Cat

hete

r (Ab

latio

n)

29

2001

U

SA

C

ardi

ac: C

athe

ter (

Abla

tion)

7

2000

U

SA

C

ardi

ac: C

athe

ter (

Abla

tion)

31

20

00

US

A

C

ardi

ac: C

athe

ter (

Angi

ogra

phy)

7

2000

U

SA

C

ardi

ac: C

athe

ter (

Angi

ogra

phy)

3

2003

U

SA

C

ardi

ac: C

athe

ter (

Angi

ogra

phy)

29

20

01

US

A

18

Car

diac

: Cat

hete

r (An

giop

last

y B

allo

ons)

7

2000

U

SA

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

21

2000

U

SA

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

3 20

03

US

A

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

8 20

00

US

A

C

ardi

ac: C

athe

ter (

Angi

opla

sty

Bal

loon

s)

21

2003

U

SA

C

ardi

ac: C

athe

ter (

Ballo

on)

7 20

00

US

A

17

4

C

ardi

ac: C

athe

ter (

Ballo

on)

3 20

03

US

A

C

ardi

ac: C

athe

ter (

Ballo

on)

3 20

03

US

A

19

Car

diac

: Cat

hete

r (E

lect

rode

Rec

ordi

ng)

3 20

03

US

A

20

Car

diac

: Cat

hete

r (E

lect

roph

ysio

logy

/EP

) 21

20

00

US

A

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

7 20

00

US

A

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

31

2000

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

23

2003

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

8 20

00

US

A

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

38

2003

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

39

2004

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

28

2000

U

SA

C

ardi

ac: C

athe

ter (

Ele

ctro

phys

iolo

gy/E

P)

29

2001

U

SA

21

Car

diac

: Cat

hete

r (Fi

ber-o

ptic

Oxi

met

er)

3 20

03

US

A

22

Car

diac

: Cat

hete

r (G

uide

wire

) 3

2003

U

SA

C

ardi

ac: C

athe

ter (

Gui

dew

ire)

7 20

00

US

A

C

ardi

ac: C

athe

ter (

Gui

dew

ire)

35

1999

U

SA

23

Car

diac

: Cat

hete

r (H

aem

o-di

alys

is)

29

2001

U

SA

24

Car

diac

: Cat

hete

r (H

igh

Den

sity

Arra

y)

3 20

03

US

A

25

Car

diac

: Cat

hete

r (Ke

rato

me)

3

2003

U

SA

26

Car

diac

: Cat

hete

r (St

eera

ble)

3

2003

U

SA

27

Car

diac

: Ext

erna

l Vei

n S

tripp

er

3 20

03

US

A

17

5

28

Car

diac

: Pac

emak

er

29

2001

U

SA

29

Car

diac

: Sta

biliz

er D

evic

e 3

2003

U

SA

30

Car

diac

: Syr

inge

3

2003

U

SA

C

ardi

ac: S

yrin

ge

7 20

00

US

A

31

Car

diac

: Syr

inge

(In

ject

or T

ype

Act

uato

r) 3

2003

U

SA

32

Car

diac

: Syr

inge

(Ang

iogr

aphe

r Inj

ecto

r) 21

20

00

US

A

33

Car

diac

: Tra

cers

39

20

04

US

A

34

Car

diac

: Tro

car

3 20

03

US

A

C

ardi

ac: T

roca

r 7

2000

U

SA

35

Car

diac

: Vei

n S

tripp

er

3 20

03

US

A

36

Car

diac

: Wire

s 25

19

99

US

A

C

ardi

ac: W

ires

35

1999

U

SA

37

Dia

rther

my

3 20

03

US

A

38

Dia

ther

my:

App

arat

us

3 20

03

US

A

D

iath

erm

y: C

uttin

g an

d C

oagu

latio

n D

evic

es

3 20

03

US

A

39

Dia

ther

my:

Ele

ctro

des

21

2000

U

SA

D

iath

erm

y: E

lect

rode

s 8

2000

U

SA

D

iath

erm

y: E

lect

rode

s 7

2000

U

SA

40

Dia

ther

my:

Pen

cils

7

2000

U

SA

D

iath

erm

y: P

enci

ls

8 20

00

US

A

41

Ele

ctro

de C

able

3

2003

U

SA

17

6

42

Ele

ctro

de: P

ercu

tane

ous

Abl

atio

n 3

2003

U

SA

43

End

osco

pe

3 20

03

US

A

E

ndos

cope

7

2000

U

SA

E

ndos

cope

53

20

04

US

A

44

End

osco

py: B

lade

s 7

2000

U

SA

E

ndos

copy

: Bla

des

3 20

03

US

A

45

End

osco

py: G

uide

wire

s 7

2000

U

SA

E

ndos

copy

: Gui

dew

ires

3 20

03

US

A

46

End

osco

py: S

ciss

ors

39

2004

U

SA

47

EN

T: B

urr

58

2004

U

SA

E

NT:

Bur

r 3

2003

U

SA

48

EN

T: C

athe

ter

7 20

00

US

A

49

EN

T: C

athe

ter (

Trac

heob

ronc

hial

) 7

2000

U

SA

E

NT:

Cat

hete

r (Tr

ache

obro

nchi

al)

3 20

03

US

A

E

NT:

Cat

hete

rs

3 20

03

US

A

50

EN

T: T

roca

r 58

20

04

US

A

51

Fasc

ia H

olde

rs

7 20

00

US

A

52

Fem

osto

ps

23

2003

U

SA

53

Fibr

eopt

ic L

aser

Cab

le

3 20

03

US

A

54

Gas

troen

tero

logy

/ U

rolo

gy: B

iops

y Fo

rcep

s

3 20

03

US

A

G

astro

ente

rolo

gy /

Uro

logy

: Bio

psy

Forc

eps

28

20

00

US

A

17

7

G

astro

ente

rolo

gy /

Uro

logy

: Bio

psy

Forc

eps

(Ele

ctric

) 3

2003

U

SA

55

Gas

troen

tero

logy

/ U

rolo

gy: B

iops

y In

stru

men

t 3

2003

U

SA

56

Gas

troen

tero

logy

/ U

rolo

gy: B

iops

y Pu

nch:

3

2003

U

SA

57

Gas

troen

tero

logy

: Bio

psy

Forc

eps

(Non

-ele

ctric

al)

58

2004

U

SA

G

astro

ente

rolo

gy: B

iops

y Fo

rcep

s (N

on-e

lect

rical

) 7

2000

U

SA

G

astro

ente

rolo

gy: B

iops

y Fo

rcep

s (N

on-e

lect

rical

) 3

2003

U

SA

58

Gas

troen

tero

logy

: Cyt

olog

y br

ushe

s

3 20

03

US

A

59

Gas

troen

tero

logy

: Ele

ctro

de (A

ctiv

e EP

) 3

2003

U

SA

60

Gas

troen

tero

logy

: E

lect

rode

(F

lexi

ble

Suct

ion

Coa

gula

tor)

3

2003

US

A

61

Gas

troen

tero

logy

: Sto

ne D

islo

dger

3

2003

U

SA

62

Gen

eral

Sur

gery

: Bio

psy

Nee

dle

7 20

00

US

A

63

Gen

eral

Sur

gery

: Der

mat

ome

3

2003

U

SA

64

Gen

eral

Sur

gery

: Dis

sect

or

3 20

03

US

A

65

Gen

eral

Sur

gery

: Dra

pes

(Unu

sed)

7

2000

U

SA

66

Gen

eral

Sur

gery

: Ext

ract

or

7 20

00

US

A

G

ener

al S

urge

ry: E

xtra

ctor

3

2003

U

SA

67

Gen

eral

Sur

gery

: Saw

Bla

des

7 20

00

US

A

68

Gen

eral

Sur

gery

: Sta

pler

3

2003

U

SA

G

ener

al S

urge

ry: S

tapl

er

7 20

00

US

A

G

ener

al S

urge

ry: S

tapl

er

39

2004

U

SA

17

8

G

ener

al S

urge

ry: S

tapl

er

3 20

03

US

A

69

Gen

eral

Sur

gery

: Sta

pler

(End

osco

pic)

7

2000

U

SA

70

Gen

eral

Sur

gery

: Sta

pler

(Pla

stic

Sur

gery

) 7

2000

U

SA

70

Gen

eral

Sur

gica

l Cla

mp

(Vas

cula

r) 3

2003

U

SA

71

Gen

eral

Sur

gica

l: B

iops

y 53

20

04

US

A

G

ener

al S

urgi

cal:

Bio

psy

Bru

sh

3 20

03

US

A

72

Gen

eral

Sur

gica

l: B

iops

y D

evic

e (P

ercu

tane

ous)

3

2003

U

SA

73

Gen

eral

Sur

gica

l: B

iops

y Fo

rcep

s 39

20

04

US

A

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

7 20

00

US

A

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

59

2003

U

SA

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

26

2003

U

SA

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

3 20

03

US

A

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

22

2002

U

SA

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

38

2003

U

SA

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

35

1999

U

SA

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

8 20

00

US

A

G

ener

al S

urgi

cal:

Bio

psy

Forc

eps

23

2003

U

SA

74

Gen

eral

Sur

gica

l: B

lade

s 39

20

04

US

A

75

Gen

eral

Sur

gica

l: C

hise

l 3

2003

U

SA

76

Gen

eral

Sur

gica

l: C

lam

p

3 20

03

US

A

77

Gen

eral

Sur

gica

l: C

lip

58

2004

U

SA

17

9

78

Gen

eral

Sur

gica

l: C

lip (I

mpl

anta

ble)

3

2003

U

SA

79

Gen

eral

Sur

gica

l: C

uttin

g A

cces

sorie

s 7

2000

U

SA

80

Gen

eral

Sur

gica

l: D

rill B

it

3 20

03

US

A

81

Gen

eral

Sur

gica

l: H

emos

tatic

Clip

App

lier

3 20

03

US

A

82

Gen

eral

Sur

gica

l: H

ook

3

2003

U

SA

83

Gen

eral

Sur

gica

l: K

nife

3

2003

U

SA

84

Gen

eral

Sur

gica

l: O

steo

tom

e

3 20

03

US

A

85

Gen

eral

Sur

gica

l: R

etra

ctor

3

2003

U

SA

86

Gen

eral

Sur

gica

l: S

tapl

e (Im

plan

tabl

e)

3 20

03

US

A

87

Gen

eral

Sur

gica

l: S

tapl

e A

pplie

r 3

2003

U

SA

88

Gen

eral

Sur

gica

l: S

tapl

e D

river

3

2003

U

SA

89

Gen

eral

Sur

gica

l: S

tapl

er (P

last

ic S

urge

ry)

3 20

03

US

A

90

Gen

eral

Sur

gica

l: S

uctio

n Tu

bing

7

2000

U

SA

91

Gen

eral

Sur

gica

l: S

utur

es (n

on-s

teril

e)

7 20

00

US

A

G

ener

al S

urgi

cal:

Sut

ures

(non

-ste

rile)

22

20

02

US

A

92

Gen

eral

Sur

gica

l: S

utur

es (S

tom

ach

/ Int

estin

al)

3 20

03

US

A

96

Gen

eral

Sur

gica

l: Tr

ocar

3

2003

U

SA

G

ener

al S

urgi

cal:

Troc

ar

38

2003

U

SA

G

ener

al S

urgi

cal:

Troc

ar

23

2003

U

SA

G

ener

al S

urgi

cal:

Troc

ar

39

2004

U

SA

G

ener

al S

urgi

cal:

Troc

ar

7 20

00

US

A

18

0

G

ener

al: A

nti D

VT

garm

ents

7

2000

U

SA

G

ener

al: A

nti D

VT

garm

ents

3

2003

U

SA

G

ener

al: A

nti D

VT

garm

ents

53

20

04

US

A

97

Gen

eral

: Blo

od a

cces

s de

vice

3

2003

U

SA

G

ener

al: B

lood

Lan

cet

3 20

03

US

A

98

Gen

eral

: Blo

od P

ress

ure

53

2004

U

SA

G

ener

al: B

lood

Pre

ssur

e C

uffs

7

2000

U

SA

G

ener

al: B

lood

Pre

ssur

e C

uffs

3

2003

U

SA

G

ener

al: B

lood

Pre

ssur

e C

uffs

39

20

04

US

A

99

Gen

eral

: Cat

hete

r 22

20

02

US

A

G

ener

al: C

athe

ter

59

2003

U

SA

G

ener

al: C

athe

ter

10

2001

U

SA

G

ener

al: C

athe

ter

61

2004

U

SA

100

Gen

eral

: Cat

hete

r (D

iagn

ostic

) 3

2003

U

SA

101

Gen

eral

: Cat

hete

r (D

rain

age)

3

2003

U

SA

102

Gen

eral

: Cur

ette

(sur

gica

l) 3

2003

U

SA

103

Gen

eral

: Syr

inge

61

20

04

US

A

104

Gen

eral

: Syr

inge

(Irri

gatin

g)

3 20

03

US

A

G

ener

al: S

yrin

ge (I

rriga

ting)

7

2000

U

SA

105

Gen

eral

: Syr

inge

(Pis

ton)

3

2003

U

SA

106

Gen

eral

: Tou

rniq

uet

3 20

03

US

A

18

1

107

Gou

ge (S

urgi

cal)

3 20

03

US

A

108

Gow

ns

7 20

00

US

A

G

owns

3

2003

U

SA

109

Hem

odia

lysi

s B

lood

Circ

uit

3 20

03

US

A

H

emod

ialy

sis

Blo

od C

ircui

t 7

2000

U

SA

110

Hem

orrh

oida

l Lig

ator

3

2003

U

SA

111

Infla

tion

Dev

ices

23

20

03

US

A

112

Infu

sion

Pum

p 3

2003

U

SA

113

Lapa

rosc

opes

7

2000

U

SA

La

paro

scop

es

3 20

03

US

A

La

paro

scop

es

38

2003

U

SA

La

paro

scop

es

7 20

00

US

A

La

paro

scop

es

58

2004

U

SA

La

paro

scop

es

53

2004

U

SA

114

Lapa

rosc

opes

: Cla

mps

39

20

04

US

A

115

Lapa

rosc

opes

: Dis

sect

ors

7 20

00

US

A

La

paro

scop

es: D

isse

ctor

s 39

20

04

US

A

La

paro

scop

es: D

isse

ctor

s 3

2003

U

SA

La

paro

scop

es: D

isse

ctor

s

7 20

00

US

A

116

Lapa

rosc

opes

: For

ceps

39

20

04

US

A

117

Lapa

rosc

opes

: Gra

sper

s 7

2000

U

SA

18

2

La

paro

scop

es: G

rasp

ers

39

2004

U

SA

La

paro

scop

es: G

rasp

ers

3

2003

U

SA

118

Lapa

rosc

opes

: Sci

ssor

s 7

2000

U

SA

La

paro

scop

es: S

ciss

ors

21

2000

U

SA

La

paro

scop

es: S

ciss

ors

38

2003

U

SA

La

paro

scop

es: S

ciss

ors

8 20

00

US

A

La

paro

scop

es: S

ciss

ors

39

2004

U

SA

La

paro

scop

es: S

ciss

ors

3 20

03

US

A

119

Lase

r Fib

re D

eliv

ery

Sys

tem

s 7

2000

U

SA

120

Mec

hani

cal W

rist

3 20

03

US

A

121

Nee

dle

3 20

03

US

A

N

eedl

e 58

20

04

US

A

122

Nee

dle

Des

truct

ion

Dev

ice

3

2003

U

SA

123

Nee

dle

Hol

der

3

2003

U

SA

124

Nee

dle:

Ang

iogr

aphi

c 3

2003

U

SA

125

Nee

dle:

Asp

iratio

n an

d In

ject

ion

3

2003

U

SA

N

eedl

e: A

spira

tion

and

Inje

ctio

n 58

20

04

US

A

126

Nee

dle:

Ass

iste

d R

epro

duct

ion

3 20

03

US

A

127

Nee

dle:

Bio

psy

26

20

03

US

A

N

eedl

e: B

iops

y

25

1999

U

SA

N

eedl

e: B

iops

y

58

2004

U

SA

18

3

N

eedl

e: B

iops

y

7 20

00

US

A

N

eedl

e: B

iops

y

3 20

03

US

A

128

Nee

dle:

Car

diov

ascu

lar

7 20

00

US

A

129

Nee

dle:

Cat

hete

r 58

20

04

US

A

130

Nee

dle:

Con

duct

ion

3 20

03

US

A

131

Nee

dle:

Hyp

oder

mic

Sin

gle

Lum

en

3 20

03

US

A

132

Nee

dle:

Isot

ope

3

2003

U

SA

133

Nee

dle:

Pha

ecom

ulsi

ficat

ion

7 20

00

US

A

N

eedl

e: P

haec

omul

sific

atio

n

3 20

03

US

A

134

Nee

dle:

Pne

umpe

riton

eum

3

2003

U

SA

135

Nee

dle:

Sho

rt-te

rm S

pina

l 3

2003

U

SA

136

Nee

dle:

Sin

gle

Lum

en

3 20

03

US

A

137

Neu

rosu

rger

y: B

urrs

3

2003

U

SA

138

Neu

rosu

rger

y: C

lip

3 20

03

US

A

139

Neu

rosu

rger

y: D

rills

3

2003

U

SA

140

Neu

rosu

rger

y: T

reph

ines

3

2003

U

SA

141

OB

/GYN

: Bio

psy

Forc

eps

58

2004

U

SA

142

OB

/GYN

: Cul

dosc

opic

Coa

gula

tor

3 20

03

US

A

143

OB

/GYN

: End

osco

pic

Bip

olar

Coa

gula

tor

3 20

03

US

A

144

OB

/GYN

: End

osco

pic

Uni

pola

r Coa

gula

tor

3 20

03

US

A

145

OB

/GYN

: Hys

tero

scop

ic C

oagu

lato

r 3

2003

U

SA

18

4

146

OB

/GYN

: Lap

aros

cope

s

3 20

03

US

A

147

OB

/GYN

: Tro

car

7 20

00

US

A

148

Ope

ned

but u

sed

item

s 39

20

04

US

A

149

Oph

thal

mic

: Bla

de (K

erat

ome)

3

2003

U

SA

O

phth

alm

ic: B

lade

(Ker

atom

e)

7 20

00

US

A

150

Oph

thal

mic

: End

o-illu

min

ator

3

2003

U

SA

151

Oph

thal

mic

: Kni

fe

3 20

03

US

A

O

phth

alm

ic: K

nife

58

20

04

US

A

152

Orth

opae

dic:

Bla

de (C

arpa

l Tun

nel)

3

2003

U

SA

O

rthop

aedi

c: B

lade

(Car

pal T

unne

l)

7 20

00

US

A

153

Orth

opae

dic:

Arth

osco

pic

Acc

esso

ries

3

2003

U

SA

154

Orth

opae

dic:

Arth

osco

pic

shav

ers

& w

ands

38

20

03

US

A

O

rthop

aedi

c: A

rthos

copi

c w

ands

23

20

03

US

A

155

Orth

opae

dic:

Arth

rosc

opic

inst

rum

ents

7

2000

U

SA

O

rthop

aedi

c: A

rthro

scop

ic S

have

rs

39

2004

U

SA

156

Orth

opae

dic:

Bla

des

23

20

03

US

A

157

Orth

opae

dic:

Bon

e H

ook

(Sur

gica

l) 3

2003

U

SA

158

Orth

opae

dic:

Bon

e Ta

p

3 20

03

US

A

159

Orth

opae

dic:

Bur

r

3 20

03

US

A

O

rthop

aedi

c: B

urr

23

20

03

US

A

O

rthop

aedi

c: B

urr

7

2000

U

SA

18

5

O

rthop

aedi

c: B

urr

39

20

04

US

A

O

rthop

aedi

c: B

urr

53

20

04

US

A

160

Orth

opae

dic:

Cou

nter

sink

3

2003

U

SA

161

Orth

opae

dic:

Dril

l

3 20

03

US

A

O

rthop

aedi

c: D

rill B

it

7 20

00

US

A

O

rthop

aedi

c: D

rill B

it

39

2004

U

SA

O

rthop

aedi

c: D

rill B

it

61

2004

U

SA

O

rthop

aedi

c: D

rill B

it

7 20

00

US

A

O

rthop

aedi

c: D

rill B

it

21

2000

U

SA

O

rthop

aedi

c: D

rill B

it

8 20

00

US

A

162

Orth

opae

dic:

Dril

ls (F

lexi

ble)

3

2003

U

SA

163

Orth

opae

dic:

Ext

erna

l Fix

atio

n D

evic

e 38

20

03

US

A

O

rthop

aedi

c: E

xter

nal F

ixat

ion

Dev

ice

39

2004

U

SA

O

rthop

aedi

c: E

xter

nal F

ixat

ion

Dev

ice

7 20

00

US

A

O

rthop

aedi

c: E

xter

nal F

ixat

ion

Dev

ice

3 20

03

US

A

164

Orth

opae

dic:

Fle

xibl

e R

eam

ers

/ Dril

ls

7 20

00

US

A

165

Orth

opae

dic:

Hip

Joi

nt

3 20

03

US

A

166

Orth

opae

dic:

Kne

e Jo

int

3 20

03

US

A

167

Orth

opae

dic:

Kni

fe

3 20

03

US

A

168

Orth

opae

dic:

Ras

p

3 20

03

US

A

169

Orth

opae

dic:

Rea

mer

3

2003

U

SA

18

6

170

Orth

opae

dic:

Sho

ulde

r Joi

nt

3 20

03

US

A

171

Orth

opae

dic:

Tre

phin

e

3 20

03

US

A

172

Orth

opae

dics

: Ron

geur

3

2003

U

SA

173

Pha

co T

ips

39

2004

U

SA

174

Pha

cofra

gmen

tatio

n sy

stem

3

2003

U

SA

175

Pne

umat

ic T

ourn

ique

t Cuf

fs

39

2004

U

SA

176

Pro

be: A

rgon

bea

m p

lasm

a co

agul

atio

n

25

1999

U

SA

177

Pro

lene

mes

h 7

2000

U

SA

178

Pro

sthe

sis

38

2003

U

SA

179

PTC

A

53

2004

U

SA

180

Pul

se O

xim

eter

3

2003

U

SA

P

ulse

Oxi

met

er

53

2004

U

SA

181

Pul

se O

xim

eter

Sen

sors

39

20

04

US

A

P

ulse

Oxi

met

er S

enso

rs

28

2002

U

SA

182

Rad

iolo

gy: C

athe

ter

29

2001

U

SA

183

Saw

53

20

04

US

A

S

aw

3 20

03

US

A

S

aw

39

2004

U

SA

184

Saw

Bla

de

3 20

03

US

A

S

aw B

lade

7

2000

U

SA

S

aw B

lade

61

20

04

US

A

18

7

S

aw B

lade

21

20

00

US

A

S

aw B

lade

59

20

03

US

A

S

aw B

lade

8

2000

U

SA

185

Sca

lpel

bla

de

3 20

03

US

A

186

Sci

ssor

Tip

s

7 20

00

US

A

187

Sci

ssor

s 39

20

04

US

A

S

ciss

ors

3

2003

U

SA

S

ciss

ors

25

19

99

US

A

S

ciss

ors

35

19

99

US

A

S

ciss

ors

26

20

03

US

A

S

ciss

ors

Tips

3

2003

U

SA

188

Sha

rps

Con

tain

ers

7 20

00

US

A

189

Sna

re

3 20

03

US

A

S

nare

39

20

04

US

A

190

Sof

t Tis

sue

Abla

tors

39

20

04

US

A

191

Spa

tula

3

2003

U

SA

192

Sph

inct

erto

me

70

1998

U

SA

S

phin

cter

tom

e 7

2000

U

SA

S

phin

cter

tom

e 3

2003

U

SA

S

phin

cter

tom

e 53

20

04

US

A

193

Sur

gica

l: C

athe

ter N

eedl

e

3 20

03

US

A

18

8

194

Syr

inge

Pis

ton

& In

fusi

on Im

plan

ted

Pum

ps

7 20

00

US

A

195

Uro

logy

: D

ialy

sis

Set

3

2003

U

SA

196

Uro

logy

: Cat

hete

r (B

iliary

) 3

2003

U

SA

197

Uro

logy

: Cat

hete

r (U

reth

ral)

7 20

00

US

A

U

rolo

gy: C

athe

ter (

Ure

thra

l) 3

2003

U

SA

189

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2002;75(3):557-62, 565-7

23. Solomon M. Saving money the safe way: hospitals turn to medical device

reprocessors – business focus Healthcare Review 27.05.03

www.findarticles.com

24. GfK Healthcare. Reuse of single use medical devices

http://www.bvmed.de/themen/reuse/?language=2

25. Kolata G. Single use medical devices are often used several times New York

Times 10.11.99

26. Lichtman B. Going Once, Going Twice: What Price For A Reprocessed

Device? UCLA Journal of Law and Technology Notes 2003;16.

27. Stewart I. Single use only labelling of medical devices: always essential or

sometimes spurious? Med J Aust 1997;167:538-839.

28. General Accounting Office. Single Use Medical Devices: Little Available

Evidence of Harm from Reuse But Oversight Warranted 2002 GAO:

Washington DC.

29. Mickelsen S, Mickelsen C, MacIndoe C, Jaramillo J, Bass S, West G et al.

Trends and patterns in electrophysiologic and Ablation catheter reuse in the

United States Am J of Cardio 2001;87:351-353

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30. Berenger Sj, Ferguson JK. Reuse of single use medical devices: how often

does this still occur in Australia? Med J Aust 2004;180(1):46

31. Clough J. Testimony to Congressional committees and Federal agencies on

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32. Collignon PJ, Dreimanis DE, Beckingham WD. Reuse of Single-Use Medical

Devices in Sterile Sites: How Often Does This Still Occur in Australia? Med J

Aust 2003;179(2):115-6; discussion 116

33. Woollard K. Reuse of single-use medical devices: who makes the decision?

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Med J Aust 1996;164 (9):538

34. Fedel M. Tessarolo F, Ferrari P, Losche C, Ghassemieh N, Guarrera GM et

al. Functional properties and performance of new and repocesed coronary

angioplasty balloon catheters J Biomed Mater Res B Appl Biomater

2006;Feb27 (e-print)

35. Charatan F. Controvery erupts over reuse of single use medical devices Br

Med J 1999;319:1320

36. Health Policy Forum 2002 www.forum.europa.eu.int

37. Brook CW. Reuse of single use medical devices: NHMRC deliberations Med

JAust 1996;164:537

38. Premierinc. Reuse of single use devices in USA 2003 www.premierinc.com

39. AHRMM. Reprocessing advances 2004 www.premierinc.com

40. Lindsay BD, Kutalek SP, Cannom DS, Hammill SC, Naccarelli GV. NASPE

task force on reprocessing of electrophysiological catheters. North American

society of Pacing and Electrophysiology Pacing Clin Electrophysiol

2001;24(8.1):1297-1305.

41. Eucomed. Reprocessing single use medical technology – a threat to patient

safety 2003 www.eucomed.be

42. Ryden L, Fox KM. Reuse of devices in cardiology Eur Heart J

1999;20(10):709-710

43. Ryden L. Reuse Of Devices in Cardiology Eur Heart J 1998;19:1628-1631.

44. Jackson M. Issues affecting refurbishment and reuse of pacemakers Aust

Health Rev 1996;19(1):68-80.

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47. Myers GH. Is reuse financially worthwhile? Pacing Clin Electrophysiol

1986;9(6.2):1288-1294.

48. LInde CL, Bocray A, Jonasson H, Rosenqvist M, Radegran K, Ryden L.

reused pacemakers – as safe as new? A retrospective case control study Eur

Heart J 1998;19(1):154-157.

49. Braun TC, Hagen NC, Hatfield RE, Wyse DG. Cardiac pacemakers and

implantable defibrillators in terminal care J Pain Symptom Manage

1999;18(2):126-131.

50. Havia T, Schuller H. The reuse of previously implanted pacemakers Scan J

Thorac Cardiocasc Surg Suppl 1978;(22):33-34.

51. Collignon PJ, Graham E, Dreimanis DE. Reuse In Sterile Sites Of Single-Use

Medical Devices: How Common Is This In Australia? Med J Aust.

1996;164(9):533-6.

52. Eucomed. Reuse 2002 www.eucomed.be

53. Alfa MJ, Castillo J. Impact of FDA policy change on the reuse of single use

medical devices in Michigan hospitals Am J Infect Control 2004;32(6):337-

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54. Hambrick D 3rd. Reprocessing of single use endoscopic biopsy forceps and

snares. One hospital’s study Gastroenterol Nurs 2001;24(3):112-115

55. Tapp A. Reuse of single use medical devices Can Oper Room Nurs J

2003;21(1):18-19

56. Koh A, Kawahara K. Current practices and problems in the reuse of single

use devices in Japan J Med Dent Sci 2005;52(1):81-89.

57. Furman, PJ. The Reprocessing Of Medical Devices Labelled For “Single Use”

In The US – An Historical Overview, Business Briefings and Technology

Assessment 2002; June:1-5.

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Reprocessing 2003 http://www.Knee1.com

60. Schroder P. Reuse of singe use devices Med Dev Technol

2000;11(10):44,48-53.

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62. Kings Lynn and Wisbech Hospitals NHS Trust Winning Ways 2004

63. Infection Control Nurses Forum. Message board ‘single use surgical

instruments’ 2004 www.icna.co.uk

64. Nursing Times. NT survey reveals NHS equipment crisis Nursing Times

online 01.09.03

65. Fan Q, Liu J, Ebben JP, Collincs AJ. Reuse associated mortality in incident

hemodialysis patients in the United States, 2000 to 2001 Am J Kidney Dis

46(4):661-668

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dialysis, National Kidney Foundation Am J Kidney Dis 1997;30(6):859-871

67. Dos Santos JP, Loureiro A, Cendoroglo NM, Pereira BJ. Impact of dialysis

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haemodialysis units Nephrol Dial Transplant 1996;11(10):2017-2022

68. Roth K, Heeg P, Reichl R. Specific hygiene issues relating to reprocessing

and reuse of single use devices for laparoscopic surgery Surg Endosc

2002;16(7):1091-1097.

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Trauma 2006;20(1):39-42

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sphinctertome: prospective evaluation Gastrointest Endosc 1999;48(1):58-60.

71. Alfa MJ, Nemes R. Inadequacy of manual cleaning for reprocessing single

use, triple lumen spinctertomes: simulated use testing comparing manual with

automated cleaning methods Am J Infect Control 31(4):193-207.

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evaluation of wire integrity and ability to reprocess single use sphinctertomes

Gastrointest Endosc 1997;45(2):117-121.

194

Appendix 2: Sampling strategy for survey.

We had envisaged that our web-based survey would sample 350 acute NHS

hospitals in England. We had planned to contact the Clinical Directors of Anaesthesia

(CDA) and Theatre Managers (TM) with the aim that they would be able to recruit

one anaesthetist and one surgeon who would be prepared to complete the

questionnaire. However, we discovered that this research design could not be

operationalised without serious delay, which would compromise even a partial

achievement of its goals within the available time and budget. The cause of this was

the introduction of the Research Governance Framework for Health and Social Care1

(RGF) and the European Clinical Trials Directive2 in May 2004, and its impact on

research involving members of NHS staff.

We had intended to recruit participant surgeons and anaesthetists via subscription to

an online database of NHS staff (www.specialistinfo.com) and had also hoped that

the Department of Health might be able to supply a list of contacts. However, having

taken advice from the Research and Development (R&D) department at Nottingham

University Hospitals NHS Trust about the consequences of the RGF, it became clear

that we could not approach NHS staff directly, or be given their personal data (i.e.

name and contact details) by third parties such as Trust Human Resources (HR)

departments. Any approach to NHS staff regarding their participation in the research

would need to come from their employer. Consequently the options available to us

were to recruit via HR departments, or Chief Executives and Clinical Directors if their

contact details were publicly accessible. These parties would then need to ask staff if

they would like to participate in the research and to contact us if they were happy to

take part.

Such a recruitment strategy was considered problematic. Firstly, it was dependent

upon the initial contact’s agreement to follow the strategy, and would then also be

reliant upon staff contacting us. Secondly, such a strategy would be extremely time

consuming.

Moreover, in order to follow this approach, we would need R&D organisational

approval for every NHS Trust invited to participate in the survey. Our original search

had shown that approximately 350 hospitals in England fitted the sampling criteria

(acute NHS hospitals). Although several of these hospitals will have fallen into the

195

same NHS Trust, up to 1400 signatures from R&D and clinical staff would have been

required, even before the sample was recruited or any survey data was collected.

Gaining R&D organisational approval is not a straightforward task. Prior to May 2005,

R&D departments could use either part D of the form issued by the Central Office for

Research Ethics Committees (COREC) or their own version. Using the form from

Nottingham City Hospital as an example, R&D approval to for sample recruitment at

just one site involves:

1. A completed R&D application form (4 pages in length and requiring

signatures from 4 members of hospital staff)

2. Copy of research protocol

3. Copy of completed COREC parts A, B and C

4. A completed copy of the hospital’s own R&D costings form

5. All correspondence between the ethics committee and the research team

6. An independent, external peer review of the research

7. A copy of the invitation letter on hospital letter-headed paper

8. A copy of the consent form on hospital letter-headed paper

9. A copy of the questionnaire on hospital letter-headed paper

10. Researcher’s CV

11. Evidence of sponsorship

In addition to the 1400 signatures, the need for items 7-9 to be on individual hospital

letter-headed paper would create extensive delays. It also emerged that most sites

would require individual honorary contracts involving police record checks and

occupational health examinations for the research fellow. Based on the experience of

undergoing repeated health examinations and renewing CRB checks gained when

completing the last phase of the study, the potential for both delay and facing

repeated testing when hospitals are unwilling to accept others’ data, would have only

further added to be bureaucratic administration involved in gaining R&D approval for

a national survey. Given these obstacles, it was considered that the administrative

burden of gaining R&D approval from 350 sites was prohibitive. Compliance would

have required the team to do nothing else for most of the contracted period of the

project at the expense of the funded objectives.

Finally, we became aware that any data collection request made to the Department

of Health would also involve approval from the Gateway department based in Leeds.

196

The Gateway department would, having assessed the questionnaire, determine if the

request would place a disproportionate burden on the NHS. During this process,

Gateway could have altered the questionnaire against our wishes, and those of the

commissioners, or even prevented the survey from taking place, despite the fact that

it had been commissioned by an NHS body.

Given the obstacles in recruiting survey participants under this regime, an alternative

strategy was developed. The criteria for our sample would be that participants would

be members of professional associations for surgeons, anaesthetists, theatre nurses

and operating department practitioners. The professional backgrounds of these

participants would be similar to those participants whom we had originally hoped to

recruit. However, in this instance they would be recruited because of their

membership of a professional organisation rather than by virtue of their employment

in the NHS. Although this would not enable us to achieve the original goal of mapping

the prevalence of SUD reuse, this approach would give us some information about

incidence that would still enable us to adopt a case-control design for the qualitative

phase of the study: we would be able to use the information collected on the

characteristics of hospitals and test this to see if there was any associated with

reports of SUD reuse. If such associations were found, we could then select our

sample accordingly.

We were advised by contacts in the research ethics and R&D communities that our

change in recruitment strategy would allow us legitimately to circumvent the ethics

and governance system. However, prior agreement to this change in strategy was

also sought from Professor Lilford, in his capacity of director of the Patient Safety

Research Portfolio. With this approval, the Chairs of the relevant professional

organisations (Association of Surgeons of Great Britain and Ireland (ASGBI),

Association of Anaesthetists of Great Britain and Ireland (AAGBI), National

Association of Theatre Nurses (NATN) and Association of Operating Department

Practitioners (AODP)) were contacted and asked if they would agree to allow the

research team to invite their members to participate in the research.

Discussions between the research team and both the NATN and ASGBI led to

agreement over the sampling strategy and the involvement of these organisations

being reached quickly. The research team were not provided with any contact details

for members of either association. Rather, the NATN and ASGBI were sent flyers

which were then forwarded onto their members in their routine mailings. This activity

197

incurred costs that were not budgeted for in the original research proposal, but which

were covered by virement. 8500 flyers were sent to members of the NATN with their

October 2004 edition of the British Journal of Perioperative Nursing. 1,500 flyers

were sent to members of the ASGBI who work in general, breast, coloproctology,

endoscopy, gastroenterology, transplant and vascular surgeries with their

September/October 2004 Executive Newsletter.

Negotiations with the AAGBI were prolonged. Initially, Dr Rowley made contact with

Professor John Carter, then Chairman of the AAGBI Safety Committee. However,

this approach appeared to be unsuccessful and Professor Aitkenhead wrote to

Professor Mike Harmer, President of the AAGBI, repeating our request. A list of

Equipment Officers, anaesthetists with a designated responsibility for equipment

issues, was finally received from the AAGBI Safety Committee in November 2004,

following the Council meeting. The list contained 145 names and addresses, and

after cleaning to remove ineligible cases (non-English places of employment, private

hospital, repeated entries), 119 Equipment Officers were sent a letter inviting their

participation in the research. Two invitations were subsequently returned due to the

addressee being unknown at the address provided.

Recruitment of AODP members was problematic, and remained unresolved by the

deadline for completion of the survey. We had initially contacted the Chair of the

AODP in the same manner as the other professional associations, but did not receive

a response. After much delay, we contacted the President of the AODP, who

explained that the AODP had taken the stance that we were evading the research

governance and ethics frameworks. They consequently requested confirmation from

the commissioning panel that our recruitment strategy was supported. We forwarded

this request to Professor Lilford, Director of the Patient Safety Research Portfolio, but

did not receive the information required by the AODP until after the survey had

closed. As a sign of goodwill, we nonetheless forwarded the paperwork to the AODP.

To counter the lack of involvement of the AODP, a small number of ODPs belonging

to an online message group were invited to participate in the survey. An invitation

was posted on their on-line message board after approval was given from the board’s

administrator.

Lastly, a half page advert was placed in the September/October 2004 edition of The

Operating Theatre Journal (OTJ). As with the flyers sent to the NATN and ASGBI,

the advert in the OTJ also incurred expenses outside the original budget. This

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monthly journal is sent free of charge to every UK hospital with an operating theatre.

The September/October edition of the OJT had an extended print run, as delegates

at the NATN congress were given a copy in their conference pack.

None of the professional organisations held electronic mailing lists, and as such,

sample recruitment was performed using printed flyers, letters and advertisements.

Consequently, the security features required for the website were reduced.

Participants were only able to gain entrance to the survey site once they had

completed a consent form that was found at the gateway to the survey pages.

Moreover, the inputted data was only saved if the respondent provided details of their

place of employment. This data was destroyed following recruitment of the sample

for the interview phase of the study.

It is likely that the chosen recruitment strategy will have influenced the response rate

that the survey achieved. The lack of electronic contact details meant that we were

unable to track respondents or issue reminder emails. Moreover, the flyers and

letters were sent cold. Respondents neither knew that they would be invited to

participate in a survey, or who the research team were in advance of being sent the

flyer/letter or reading the advertisement. To lessen the impact of this cold contact

strategy, and as an incentive to participate in the survey, we offered the prize of a

case of champagne for one lucky participant. The prize was drawn randomly on 15th

December 2004, after the survey deadline had passed and the recipient was

contacted to arrange delivery.

References

1. Department of Health. Research Governance Framework for Health and

Social Care London: Department of Health 2001

2. European Union. Directive 2001/20/EC of the European parliament and of the

council 4th April 2001 Official Journal of the European Communities

2001;L121:34-44

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Appendix 3. Ineligible Survey Data

As reported in our discussion of the survey data, of the 113 responses received, 22

of these were ineligible. Respondents were recorded as not working in the English

NHS sector, and therefore did not fit our sampling criteria. However, the results offer

some interesting comparison, and highlight the need for further research into reuse of

single use devices in the private sector.

Data Characteristics

Despite the participation invitation clearly stating that the research was only asking

about reuse of SUDs in English NHS operating theatres, 54% of ineligible cases

were made by staff working in private hospitals in England. The remaining ineligible

cases came from clinical staff working in Wales (9%), Ireland (5%), Scotland (27%),

and unexpectedly, Australia (5%).

Table 23: Data characteristics

Total

Theatre

Nurse

Clinical

Procurement

Theatre

Manager

Location Wales 2 0 0 2

Scotland 4 1 1 6

Ireland 0 0 1 1

Australia 1 0 0 1

Private 11 0 1 12

Total 18 1 3 22

The cases from elsewhere in the British Isles have been excluded as the NHS is

devolved to each country: for example, the policy on SUD usage for tonsillectomy

differs between England and Wales.

Of the 12 private cases excluded from the main analysis, 11 responses were from

nurses, whilst the remaining respondent was a theatre manager. 42% of these

respondents had been in post for up to five years, with 58% working at the hospital

for five years or more.

200

In a similar manner to the main body of data, ineligible cases were geographically

spread.

Single Use Devices and Their Reuse

In the similar manner to the main body of data, respondents working in private

hospitals also demonstrated that there is no consistent understanding of ‘single use’.

Table 24: Definitions of single use

N %

Single patient 10 83

Single episode 8 67

Used on a single occasion within a single episode 2 17

Non-reprocessable 11 92

Disposable 11 92

As with the main body of data, respondents were less likely to support definitions of

‘single use’ that described the single episode of use. Respondents considered that

SUDs should be disposable (92%) and non-reprocessable (92%), and that they

should only be used on one patient (83%). Such support reiterates our earlier

argument that there is little objective understanding about what ‘single use’

constitutes amongst clinical endusers. Respondents working in the private sector

17%

25% 8%

8%

8%

17%

17%

201

were more likely to consider a SUD to be something that cannot be reprocessed and

must be disposed of, rather than a device that should be used once and then

discarded.

Seven respondents reported the reuse of SUDs:

Table 25: Single use devices reported as being reused

Total

(N)

Every

operation

More

than

once a

week

More

than

once a

month

More than

once a

year

Laryngoscope blades 3 2 0 1 0

Drill bits 2 1 1 0 0

Compression garments 2 2 0 0 0

Saw blades 1 0 0 0 1

Disposable suction bottle

liners 1 1 0 0 0

LMAs 1 0 1 0 0

Guidewires 1 0 0 1 0

Anaesthetic tubing 1 0 1 0 0

Dental burrs 1 1 0 0 0

GU irrigation tubing 1 1 0 0 0

Puddle floor vacs 1 1 0 0 0

Pins that hold cutting jigs 1 1 0 0 0

Many of the items listed will not come into direct contact with either the patient’s skin

or the surgical site. Consequently, items such as puddle floor vacs, suction bottle

liners, compression garments and pins that hold cutting jigs may not need to be

labelled as ‘for single use only’.

However, some of the other devices that were reported as being reused do come into

contact with the patient. In addition to devices such as laryngoscope blades, LMAs

and anaesthetic tubing, which were discussed earlier in this report, the reuse of drill

bits, burrs and guidewires might be considered alarming. These devices become

202

fatigued with use, which if reused, can lead to a patient safety incident through

device failure or breakage. Despite this threat, one respondent claimed that a

“Medical rep [had] indicate[d] that guidewires are strong and can be reused even

though the packaging suggest single-use” (ID 42 / Nurse). Further rationales for

reuse included the prohibitive cost of replacing each SUD (25%), the lack of risk

associated with reuse (17%) and the lack of other equipment (17%).

Respondents working in the private sector considered that the dangers of reusing

SUDs included a risk of cross contamination and infection (N=6), the possibility that

the device could be faulty on the second and subsequent use (N= 5), the inability to

adequately clean the devices (N=3) and that reuse breaches the manufacturer’s

guidelines (N=1).

92% of respondents working in the private sector stated that they were aware of their

hospital’s guidelines on the use of SUDs. All described how the guidelines reiterated

that single use means single use. However, as discussed throughout this report,

endusers appear confused about what ‘single use’ actually means in practice.

Similar patterns of reuse have been reported by the 12 respondents working in the

private sector, to those reported by respondents working in the NHS. It is proposed

therefore, that the constraints, which lead to SUDs reuse, are not unique to the NHS.

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Appendix 4: Interview methodological details

All research involving NHS staff, patients, facilities, records or tissue samples must

be considered by an appropriate ethics committee16. Research falling across more

than one domain (SHA) must be considered by a multi-site research ethics

committee (MREC). Ethical approval was sought from the Trent MREC, and gained

in July 2005.

The initial ethical application and associated documents amounted to 116 A4 pages.

Subsequent amendments created a further 60 pages of paperwork, amounting to a

total of 176 pages. From date of submission to receiving ethical approval, the MREC

process took 63 working days (03.05.05 – 28.07.05). However, COREC operate a

60-day limit on applications, which begins from the final date in which applications

can be submitted for the forthcoming meeting, and contains a start-stop element, in

which the ‘clock’ is stopped between each correspondence being sent and a reply

received. Consequently, the 60-day limit began nine working days following our

submission (16.05.05), and was stopped and started twice (15.06.05 - 23.06.05,

14.07.05 - 26.07.05). The ‘official’ length of the MREC process was therefore 41

working days.

NHS Trust R&D approval was sought concurrently with ethical approval. R&D

approval has been described as a “cumbersome” practice1 and implemented in

different ways and with varying application processes2. The introduction of the

‘standardised’ R&D form in May 2005 was intended to address the problem of

inconsistent processes. Nevertheless, the system continues to be in a state of

confusion.

Locating R&D departments was a problematic and time-consuming process.

Morecroft et al3 described their difficulty in dealing with switchboard personnel, which

we shared: when asking to be put through to the R&D department, we were

transferred, in one instance, to the social care department, and, in another, to the

palliative nursing team. Other hospital switchboards denied the existence of an R&D

16 Following the 2005 Warner review4, it is likely that research involving NHS staff will

not be required to undergo ethical consideration at committee level, unless ‘material

ethical issues’ arise. However, applications will still need approval by COREC

National Research Ethics Advisors.

204

department. Finally, we gained access to an online resource hosted by the NHS

R&D forum. Using this, R&D co-ordinators for each of the Trusts were easily

identified and contacted, to establish their preferred formats for applications.

Despite the standardised form, significant variation in the application process

remains. Five of the eight Trusts accepted the new standardised form. One of these

decided to accept the new form (and only the new form) one week before the

application was due to be submitted. Previously, they had only accepted applications

on their own form, which meant that the paperwork had to be amended at short

notice. All Trusts required authorisation signatures but the job titles of the signatories

varied, introducing further delays and difficulties in making contact.

Applications to the eight Trusts were submitted between May and June 2005. These

averaged 90 pages in length. In addition to the completed R&D application form,

which was an average of nine pages in length and required signatures from up to

four members of hospital staff, each application pack required:

1. A copy of research protocol, in both scientific and lay language

2. A diagram of the research design

3. A copy of the completed ethics (COREC) form

4. A copy of the research budget, in some cases on the hospital’s own financial

proforma

5. A copy of all correspondence between MREC and the research team

6. A copy of an independent, external peer review of the research

7. A copy of the invitation letter

8. A copy of the consent form

9. A copy of the questionnaire

10. The researchers CVs (both Professor Dingwall’s and Dr Rowley’s CVs were

required)

11. Evidence of sponsorship

Following receipt of the applications, the R&D committees considered the study. In

some cases this was carried out quickly (for example, two hospitals considered the

application just a few days after it was received). However, in others, the study had

not been considered for approval four months after the application was made. (A full

log of the application process in each Trust can be found in the Appendix five).

205

Several Trusts questioned some aspect of the application, but there was no

consistency in the queries, despite identical submissions. One hospital queried

whether Professor Dingwall or Dr Rowley should be recognised as the principal

researcher, although COREC guidelines clearly state that the principal researcher is

the field-researcher (Dr Rowley). At a second hospital, the research’s sponsorship

was challenged. Originally, the University of Nottingham had agreed to act as

sponsor, after being told that the Department of Health would not, but Department

policy later changed. A revision of arrangements to reflect this would have introduced

further delays but fortunately the commissioners and the university were able to

resolve the question.

Most sites required individual honorary contracts for the principal researcher. The

RGF requires that “researchers who do not have a paid contract with a NHS body

but whose research involves NHS staff or patients, their organs, tissue or data must

have an honorary contract with a NHS body”5. An honorary contract to cover the

whole of the NHS is unavailable, yet it is intended that once one honorary contract is

gained, subsequent Trusts should accept that. In practice this is not the case, with

Trusts refusing to accept honorary contracts other than their own6.

The process of applying for an honorary contract is inconsistent3,7. In some Trusts,

an honorary contract was received by return of post following an email request. In

others, a formal letter, application form and CV needed to be sent to the R&D

director. This was then passed onto the Human Resources department, and after a

number of conversations to clarify the contract’s purpose, the paperwork was sent.

In others, in addition to the application form, Dr Rowley was required to undergo

occupational health screening (height, weight and blood pressure checks, and urine,

blood and eye sight tests) and criminal records bureau (CRB) investigation. The CRB

process led to prolonged delay. The original application to the CRB was made in

May 2005 (20.05.05) when Dr Rowley travelled to the relevant hospital Human

Resources department to deliver proof of her identity (birth certificate, driving licence

and passport). However, the application was mislaid and once found, was subjected

to repeated requests after the supplementary information that was originally supplied

was lost once more! Clearance was finally received some 83 workdays after the

application was submitted. This delay severely affected the application for an

honorary contract at another Trust, which also required CRB approval. Thus, data

collection at two Trusts (four sites) was delayed.

206

The introduction of the requirement for Trust R&D approval created an unforeseen

increase in workload and expenditure. As Watson and Manthorpe7 note, protocols

written, like ours, prior to Spring 2004 would not have incorporated the additional

time needed to prepare the paperwork, arrange for designated Trust officers to sign

the forms, and await the R&D board’s decision. Wald8 described how an R&D

application at just one Trust created an extra 44 hours of work, and an additional

£850 expenses covering staff time, travelling, telephone calls, fax messages, internet

research and consumables. Brindle9 reported how, in one study requiring 62 R&D

applications, 58 of the Trusts had their own form. These 62 applications produced

5929 pages of paperwork. Eight months after submission, just 20 Trusts had granted

approval. We estimate that this phase of the present study consumed 120 workdays

(27.04.05 – 13.10.05) and incurred additional unbudgeted costs resulting from

telephone calls, paperwork, postage and mileage.

The Theatre Manager and Clinical Director of Anaesthesia were each sent a letter

inviting them to participate in the research. Following the governance regulations,

which prevent research teams having access to any personal data about a third party

without their express agreement, letters were addressed to ‘The Theatre Manager’

and ‘The Clinical Director of Anaesthesia’, unless the individual’s name was already

known. Each respondent was asked to reply to Dr Rowley if they agreed to

participate in the research. If such an agreement was reached, an interview was

arranged and an information sheet, consent form and list of questions sent to the

participant. If a response was not received after four weeks, a follow-up telephone

call was made. Dr Rowley called the hospital's switchboard and asked to speak to

the Theatre Manager or Clinical Director of Anaesthesia (as applicable). If the

individual was unavailable, a message was left asking them to make contact, or an

email was sent if colleagues suggested that this was a more appropriate form of

communication and were able to furnish Dr Rowley with the email address.

The Theatre Manager and Clinical Director of Anaesthesia were each asked to

nominate an ODP who had responsibility for equipment, and to forward a second

letter (enclosed with the first) to them. This letter invited the ODP to participate in the

research, and asked them to contact Dr Rowley if they were happy to be recruited.

Upon such contact, an interview was arranged, and an information sheet, consent

form and list of questions were sent.

207

References

1. Meerabeau E, Ruston A, Clayton J. The Research Governance Framework

For Health And Social Care: Implications For Developing Research In

Primary Care J Res Nurs 2004;9(6):421-429

2. Dumville JC, Watson J, Raynor P, Togerson DJ. Research Governance: A

Barrier To Ethical Research? QJM 2004; 97:113-114.

3. Morecroft C, Ashcroft D, Noyce P. Research Governance And Pharmacy

Practice Research: A Case-Study The Pharmaceutical Journal 2005;274:650-

651

4. Department of Health. Report Of The Ad Hoc Advisory Group On The

Operation Of NHS Research Ethics Committees London: Department of

Health 2005.

5. Department of Health. Guidance Note on Research Governance and

Honorary Contracts London: Department of Health 2003.

6. Hill AF, Butterworth RJ, Joiner S, McGregor G, Rosser MN, Thomas DJ.

Investigation Of Variant Creutzfeldt-Jakob Disease And Other Human Prion

Diseases With Tonsil Biopsy Samples Lancet 1999;353:183-189.

7. Watson R, Manthorpe J. Research Governance: For Whose Benefit? J Adv

Nurs 2002;39(6):515-516

8. Wald D. Bureaucracy Of Research Ethics Br Med J 2004;329:282-284

9. Brindle D. (2005) Scaling Back The Paper Mountain Guardian 5th January

2005

208

Appendix 5. R&D log

Hospitals 1, 8, 9 & 10

24.05.05 Honorary contract requested (letter and CV sent)

05.07.05 Following confusion at Trust level on who should sign forms, 1st

form (H1) signed and returned.

11.07.05 2nd (H8) and 3rd (H9) forms received. Sent to Trust 12.07.05

26.07.05 Still awaiting 4th form, despite 3 follow up calls.

26.07.05 Honorary contract received.

26.07.05 Waiting for 4th form and approval (hospital 10)

18.08.05 MREC approval and documentation sent.

25.08.05 Requested that application proceed without H10

15.09.05 R&D approval received

15.09.05 Invitation letters sent

03.10.05 Arranged interview with 9ODP

05.10.05 Interview with 9ODP

09.10.05 Arranged interview with 8TM


12.10.05 Follow up call to 9CDA: new to post, so refused to participate

13.10.05 Follow up call to 1CDA and 1TM: refused to participate

18.10.05 Interview with 8TM


Hospital 2

27.04.05 R&D finance forms completed and sent to finance director

27.05.05 Clinical Director signs form

31.05.05 Forms delivered to Assistant Medical Director

02.06.05 Honorary contract requested

09.06.05 Honorary contract sent to Assistant Medical Director

24.06.05 Change of guidance: Assistant Medical Director not required to

sign form.

24.06.05 Forms and e-versions submitted

05.07.05 Preliminary R&D approval sought, subject to honorary contract

(awaiting CRB) and REC.


209

22.08.05 Request that one document be re-sent with amended date and

version number.


20.09.05 CRB clearance received

13.10.05 Honorary contract received

13.10.05 Invitation letters sent out

20.10.05 Follow up telephone calls / emails

17.11.05 Returned call from 2TM

21.11.05 Arranged interview with 2TM and 2ODP

24.11.05 Arranged interview with 2CDA

08.12.05 Interview with 2TM and 2ODP

13.12.05 Interview with 2CDA

Hospital 3


17.05.05 Forms signed and hand delivered

19.05.05 E-versions of forms sent




15.09.05 Follow up emails sent

12.10.05 Follow up telephone calls made


31.10.05 Interviews with 3TM and 3ODP

Hospital 4

03.05.05 Application for honorary contract sent

16.05.05 Forms signed and hand delivered.

19.05.05 E-versions of forms sent.

29.07.05 Receipt of application form.


15.09.05 R&D approval and honorary contract received




210

31.10.05 Interviews with 4TM, 4CDA and 4ODP

Hospital 5

19.05.05 Forms signed by Clinical Director, and collected

24.05.05 R&D forms and e-versions submitted

24.05.05 Honorary contract application submitted, with CV


21.06.05 Occupational health screening

24.06.05 Preliminary R&D approval subject to REC

18.08.05 R&D registration form sent with final REC approval


22.08.05 R&D re-submission in light of amended MREC documents



09.10.05 Follow up calls

17.10.05 Follow up calls

20.10.05 Follow up emails

20.10.05 Arrange interview with 5CDA

24.11.05 Follow up email to 5TM

29.11.05 Arrange interview with 5TM


14.12.05 Interview with 5CDA

Hospital 6

16.05.05 Forms signed and delivered by hand.

19.05.05 E-versions of forms sent.

25.05.05 R&D approval subject to REC approval.

27.06.05 Another Trust Honorary Contract accepted.


30.09.05 Interview with 6TM, 6CDA and 6ODP

06.10.05 Interview with 6SM

Hospital 7

02.06.05 Meet with Surgical Services Manager; Forms signed

03.06.05 Application forms submitted

211

03.06.05 Application for honorary contract sent.

10.06.05 Preliminary approval, subject to REC and honorary contract.






25.10.05 Arranged interview with 7ODP


27.10.05 Interviews with 7CDA, 7TM and 7ODP

Hospitals 11, 12 & 13

05.05.05 R&D form submitted (paper hard copy and e-version).

11.05.05 Offer of honorary contract received, on condition of Criminal

Record Bureau checks and occupational health screening.

20.05.05 Returned forms to HR (in person) along with proof of identity

requested (passport, driving license, bank statement).

08.06.05 Occupational Health Screening (eyesight, weight, height, BMI,

blood pressure, urine sample, rubella (tested previously), general

health questions).

27.07.05 Still waiting for CRB approval


20.09.05 CRB clearance received



13.10.05 Interview invitation letters sent

24.11.05 Follow up telephone calls/emails


05.12.06 Arrange interview with 13ODP

07.12.05 Interview with 13ODP

12.12.05 Arrange interview with 11CDA

05.01.06 Interview with 11TM and 11ODP

05.01.06 11CDA cancels interview; unable to reschedule

212

Appendix 6. Ergonomics of Single Use Devices

This report describes the design features of a set of nine different types of medical

devices in an attempt to identify how their design properties might influence the

likelihood of the reuse of single use devices. The aim of this is to identify appropriate

design recommendations for single use devices.

It is important to note that whilst the types of devices examined were selected on the

bases of accounts of clinicians in the survey and interviews conducted, the specific

manufacturers whose devices are considered here were not in any way linked to

instances of reuse. The samples used were obtained from those manufacturers

willing to kindly support our study, and this report and any illustrations within it do not

intend to make any specific recommendations regarding particular manufacturers or

companies. A full inventory of the devices considered is available at the end of this

appendix.

Two ergonomics consultants (Dr. Sarah Sharples & Dr. Beverley Norris, Institute for

Occupational Ergonomics, University of Nottingham) evaluated the devices over two

separate meetings. During these meetings, feature of the devices that might

influence reuse were noted, and single and reusable devices compared.

The features identified were classified as relating to:

• Packaging e.g. ease of opening, expense or quality

• Labelling e.g. text and symbols on device itself, card inserts for recording

sterilisation, text and symbols on package

• Material properties and design e.g. apparent quality or durability of material,

potential for sterilisation, durability of fittings etc

The following examples of devices were examined:

• Anaesthesia masks

• Oxygen mask

• Laryngeal mask

• Endotracheal tube

• Breathing system

• Bougies

213

• Electrodes and wires (diathermy)

• Pen (diathermy)

• Laryngoscope handle and blade

These devices included both single use and reusable items. It is noted that a number

of standards for the design of these items and their packaging exist1,2 and that all of

these items conform to these standards. Therefore issues raised in this report reflect

the need for consideration of the way in which these standards and design practice

could potentially change the likelihood of inappropriate reuse of the single use

versions of these devices.

Three main types of design feature were identified as influencing factors on single or

multiple device use. These were labelling, packaging and material properties and

design.

Labelling was felt to be an important influential factor as it was the main (usually only)

explicit way in which the manufacturers informed the purchaser about the appropriate

use of the device. Labelling will be particularly important for new or untrained users,

or for experienced users who are using new or unfamiliar products. However, it is

vital that this labelling is prominent, unambiguous, clear and consistent. There has

been extensive research on the effectiveness of labelling, both on-product and on

packaging3,4,5,6,7,8,9,10,11. Research has shown that effectiveness is difficult to

measure, and a variety of measurement methods have been developed4:

• Comprehension - the level of understanding of a conveyed message

• Warning detection - the time to notice a warning message in-situ on

packaging

• Reading time/rate - the time to understand, or the rate of processing, of a

warning message

• Recall - the retained learning of a warning message over time

• Hazard perception - the awareness of a hazard and the likelihood to comply

with a warning

• Behavioural compliance - a measure of changed behaviour as a result of a

warning.

214

For new users, the search time to find the label and cognitive processing time to

understand the label should be as short as possible. For users who are experienced

with the device but may not have used that particular product design or brand before

it is especially important that the labelling is prominent, as it is quite possible that two

devices may appear to look very similar, but actually one may be single use and the

other reusable.

Packaging was the second influential factor to be identified. The way in which a

device is packed can influence the judgements as to reuse in several ways. Firstly,

the quality of the packaging may lead to an assumption that the product is reusable.

An example of this is a sturdy plastic container or fabric pouch, which itself appears

to be designed for long term rather than single use (such as the single use

laryngoscope and blades shown in Figure 16).

Figure 16: Europa laryngoscope pouch

Secondly, the ease of opening of the packaging will influence the way in which the

device is prepared for theatre use – if packaging is known to be hard to tear open for

example then interview data indicated that it may well be opened in advance of its

use. If the operation is for some reason then delayed, then if strict single use

procedures are followed the device should be discarded, even though they have only

been removed from the packet, and not actually used for a medical procedure.

Finally, the packaging may affect the visibility of labelling. For example, if it is clearly

seen that the packet contains a card for recording sterilisation or use, then it is likely

to be inferred that the device is reusable.

215

Materials and design are the final influential factor. The first implication of materials

is the perceived quality (and thus cost) of the device. If a device appears to be

cheaply manufactured then it may be more likely to be considered to be single use.

Secondly, users may make judgements about the ease of sterilising a device – for

example, if a device appears to be made predominately from metal, it may be

assumed that it can withstand high temperatures and thus be sterilised and reused.

Finally, the materials used may affect the user’s perception of the ease of use and

efficacy of the device, and thus their preference for use – for example, if a reusable

device is known to be easier to use or produce a better clinical result than a single

use one then this may be selected in preference to the single use item. An example

of this given from the interviews is that the single-use bougies may not retain their

profile as well as the reusable ones.

The following sections give examples of the labelling, packaging and materials on the

sample products.

As mentioned earlier, it is important that labelling is prominent, unambiguous, clear

and consistent. A wide variety of labelling methods were used in the devices

examined.

The first point of note was how a device’s reusability was indicated. A symbol is

used by some of the manufacturers to indicate reuse. The use of the number “2”

crossed out can be considered to be reasonably intuitive to imply that the device

should not be used two (or more) times, and is indeed used in other forms in

reusable devices where there is a maximum number of uses (e.g. in the re-usable

laryngeal masks the maximum number of use is 40 and this is indicated by a crossed

out ‘41’ symbol see Figure 17).

216

Figure 17. Example of multiple use symbol

However, this symbol does not appear to have a consistent size or font style and is

not consistently used. In some cases, the label simply states in text that the device is

“single use” (see Figure 18).

Figure 18. Example of single use label that uses text only

Whilst the use of a symbol is recommended in preference to text as it is not language

dependent, where there is sufficient space the use of text to supplement a symbol is

often recommended in order to help establish the comprehension of new symbols

such as the single use symbol.

The single use symbol is performing a number of functions:

217

1. Inform and warn new users and prior to use that the product that it is single

use

2. Reminding users both during and after-use that the product is single use and

should be disposed

3. Warn users that the product should not be reused if it is found out of its

packaging

4. Reinforcing the understanding of experienced users that the product and

others in its category are single use, in order to establish a routine of disposal

(this may potentially lead to confusion if single and reusable items of the

same type are frequently interchanged)

5. Providing a check during use that the product should be disposed of after use

In order to perform functions 1-3 the symbol should be easily comprehended. To

perform functions 4 and 5, the symbol should be easily detected. From the products

reviewed the symbol is not fulfilling either of these requirements adequately.

Table 26: Detailed description of labelling

Device

Category

Manufacturer

and type

Single /

Reusable

Labelling Detailed description of

labelling

Anaesthesia

Mask

Intersurgical ref.

1120-1129,

vanilla, cherry &

strawberry scent

sizes 0-5

Single Black text

printed on

packaging

symbol on packet

Intersurgical ref.

1511-1516

(sizes 0-5)

Single Extruded

lettering on

clear plastic

neck of mask

Paper insert

inside packet

“SINGLE PATIENT

USE” on mask

symbol on paper

insert

Oxygen Mask Intersurgical

ref.1104-1105

(1105 with

tubing)

Single 2 * paper

inserts

Brand name in

extruded letters

on bottom of

mask

symbol on paper

insert

218

Laryngeal

Mask

Intersurgical

sizes 1, 1.5, 2,

2.5, 3, 4 and 5

Single Black text

printed on neck

of mask

Green printed

text on paper

packaging

symbol on mask

symbol on label

Marshall Reusable Black text on

mask printed

on neck

Paper insert

Dark blue text

on paper

packaging

symbol and

“Reusable” on neck of

mask and paper

packaging

symbol on

paper insert

Marshall Single Black text on

mask printed

on neck

Paper insert

Dark blue text

on paper

packaging

symbol “ and

“single use” on neck of

mask and paper

packaging

”single use” on

instructions

Intavent Size 3 Reusable Black text

printed on neck

Card insert

Black text on

paper

packaging

symbol on card

insert

”This is a re-usable

device” on packaging

Intavent Size 3

(LMA-Unique)

Single Black text on

neck

Green and blue

text on paper

packaging

symbol and

“single use do not

reuse” on packet

”single use do not

reuse” on device

Tracheal

tubes

Portex 5, 9 & 10

mm

Single Black text on

tube

Blue text on

paper

packaging

“Single use” on tube

Co-Axial

Breathing

Intersurgical

1.6m ref 2900

Max 7 days

use

Green text

printed on

On back of instructions

“Maximum period of

219

system packet

Paper inserts

use is 7 days”

Intersurgical ref.

2108 2121

Single Green text on

packet

Black text on

paper insert

symbol on paper

inserts

Bougies Portex sizes 6-

11mm 15ch

Reusable Black text

printed on

bougie

Paper

instructions

No usage label on

device

Eschmann Reusable Black text

printed on

bougie

White label on

box

Printed

instructions

No usage label on

device

Portex 15ch ref

100/125/515

Single Blue text

printed on

plastic

White label on

paper

Black text

printed on

bougie

symbol on paper

packet

”Single use” printed on

device

Electrodes

and wires

Unomedical ball

and blade ends

Single White label on

packet

“single use” on packet

Pen Unomedical

2700mm

Single Extruded

lettering on pen

body

Black print on

paper

“single use” in

extruded letters on

device

symbol on paper

packet

Laryngoscope Europa Reusable

handle and

single use

blade

Black text on

packaging.

Printed text on

blade and

indented

lettering on

No usage label on

handle

Single use logo

indented in green

plastic and printed on

blade

220

plastic

Penlon Reusable

handle and

single use

blade

Indented label

in clear plastic on packaging

and “single use only”.

Single use logo

indented in plastic

The positioning of the label was not at all consistent. In some cases the labelling

was on the device itself, and in others it was on the packaging. It is preferable for the

usage instructions to be on the device where possible, as the packaging is likely to

become separated from the device at some point.

Figure 19. Examples of inconsistency in font style and size in labelling

SINGLE PATIENT USE

SINGLE PATIENT USE

SINGLE USE

221

A point of particular concern was some ambiguity that was noted regarding the

definition of single use as being either single incidence of use or single patient use.

For example, the Intersurgical clear anaesthesia mask is labelled on the mask itself

as “single patient use” but on the packaging the single use symbol is displayed

(Figure 19). Conversely, the Portex tracheal tubes state on the packaging “Discard

after single use”. Alternatively, the Intersurgical breathing system is labelled on the

record card as having a maximum use period of 7 days. This ambiguity is also

evident for reusable devices – for example the Marshall re-usable laryngeal mask

has a warranty that expires after 40 uses or 2 years.

Figure 20. Labelling observed on devices

Finally, in many cases, other information regarding to make and manufacturer or

brand name is printed on the devices themselves and instructions. It is particularly

important that on the device itself the single use symbol is noticeable and is not

distracted from by the other information presented. For example, in an example

laryngeal mask a site number symbol of the number “2” in a circle would be very

easily confused with the single use symbol.

Figure 21. Example of similarity between single use icon and other item labelling.

2 SINGLE USE

222

The packaging for the devices varied considerably. In most cases the packets were

sealed plastic of some type, but in some cases these plastic packets were partly

made of paper to enable labelling to be printed on them directly. The ease of

opening of the plastic packets varied. For the oxygen mask and breathing system

the plastic packaging was easy to tear or rip, which is likely to make the packets

much easier to open and less likely to be opened in advance of use . However, this

packaging does have the disadvantage of apparently being harder to print on, as in

all cases these packets included loose paper inserts rather than labelling directly on

the packet or device.

Reusable devices tended to come in sturdier packaging, although again this was by

no means a consistent pattern. The reusable laryngoscope and bougies were notable

in that they had packaging that was rigid or apparently long lasting. The advantage

of such containers is that they also provide the opportunity for co-storage of the

sterilisation and use recording cards.

In some cases (e.g. bougies) the single and reusable devices appear to look different

(reusables have weaving visible on inside) but in others the difference is less obvious

(e.g. laryngeal masks). If devices that are reusable and single use look similar then

there is inevitably more likelihood of accidental confusion. In addition, some

materials allow labelling to be printed more visibly than others (e.g. black printing

more noticeable than extruded text).

Conclusions and Recommendations

The primary aim of this report is to identify possible influencing factors on device

single or reuse. On the basis of the short analysis conducted within this report, the

following recommendations can be made.

Recommendations for labelling:

• A consistent size and font style for single use symbol to be adopted

• A similar symbol to indicate reusability to be adopted

• Use of symbol to become industry standard

• Clarification of difference between single use and single patient use

• Symbols to be printed on devices themselves where at all possible

223

• Make size of single use labelling at least the same size as other labelling (e.g.

manufacture information) printed on device

Recommendations for packaging:

• Packaging to be easy and quick to open to prevent advance opening

• Reusable devices to clearly indicate that recording card accompanies item

• Storage for recording card to be provided in packaging for reusable item

• Packaging to be clearly labelled with single or reuse symbol

Recommendations for materials and design:

• Labelling to be printed or inscribed on all parts of device

• Materials to allow visible black printing where possible

• The design of the single use symbol may need to be reviewed to ensure

legibility and noticeability. The current symbol is not easily detected and can

be confused with product numbering systems. In particular the symbol font,

size, contrast and positioning must be standardised across the industry.

In order to establish the symbol throughout the healthcare professions the symbol

should be supplemented by an education campaign. This could take the form of

leaflets supplied with medical devices, or high noticeability information on product

packaging that introduces the symbol and instructs users to look for it on single use

devices.

References

[1] BS EN980:2003 Graphical symbols for use in the labelling of medical devices

2003 BSI: London ISBN: 058042460X

[2] ISO/TR 15223:1998 Medical devices: Symbols to be used with medical device

labels, labelling and information to be supplied. (Withdrawn – replaced by BS EN980)

1998 ISO: Geneva

[3] Cairney P & Sless D. Communication effectiveness of symbolic safety signs with

different user groups. Applied Ergonomics, 1982;13(2):91-97.

224

[4] DeJoy DM. Consumer Product Warnings: Review and analysis of effectiveness

research. Proceedings of Human Factors Society 33rd Annual Meeting, 1989;936-

940.

[5] Easterby RS & Hakiel SR. Field testing of consumer safety signs: The

comprehension of pictorially presented messages. Applied Ergonomics, 1981;12(3):

143-152.

[6] Godfrey SS, Allender L, Laughery KR & Smith VL. Warning messages: Will the

consumer bother to look? Proceedings of Human Factors Society Annual Meeting,

1983;950-954.

[7] Jaynes LS & Boles DB. The effect of symbols on warning compliance.

Proceedings of Human Factors Society 34th Annual Meeting, 1990;984-987.

[8] Kalsher MJ, Pucci S, Wogalter MS & Racicot BM. Enhancing the perceived

readability of pharmaceutical container labels and warnings: the use of alternative

designs and pictorials. Proceedings of the Human Factors and Ergonomics Society

38th Annual Meeting, 1994;384-388.

[9] Mayer DL and Laux LF. Recognisability and effectiveness of warning symbols and

pictorials. Proceedings of the Human Factors 33rd Annual Meeting, 1989; 984-988.

[10] Wogalter MS, Godfrey SS, Fontenelle GA, Desaulniers DR, Rothstein PR and

Laughery KR. Effectiveness of Warnings, Human Factors, 1987;29(5):599-612.

[11] Young SL. Increasing the noticeability of warnings: Effects of pictorial, colour,

signal icon, and border. Proceedings of Human Factors Society 35th Annual Meeting,

1991:580-584.

22

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Text

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Patient Safety: The Reuse of Single Use Devices · The filter precludes any infective or hazardous particles entering the patient’s respiratory tract from the anaesthetic gases.

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