HYGIENE Medical Devices & Processes

HYGIENE

Medical Devices & ProcessesBasic Course Tuttlingen

(Tuesday, January 16th 2018, 3.00-5.00pm)

Dr. Thomas Fengler

How to preserve hygiene & function

KARL STORZ GmbH & Co. KG

Global Quality Management & Regulatory Affairs

Department CLEANICAL®

Example: Poster for the promotion of hygienic

awareness in developing countries

By CAWST - Flickr, CC BY 2.0,

httpscommons.wikimedia.orgwindex.phpcurid=41792574

Hygiene is prevention

Hygiene

Definition

Hygiene is “the science of prevention of

diseases and the preservation, promotion

and strengthening of health.“

It is related to microbiology, infectiology

and environment protection.

And circumstances…

Microorganisms might be pathogenic

Pathogens are substances or

organisms that might cause

harmful processes in other

organisms.

Those are assigned in medicine

the property of pathogenicity.

Pathogens can be bacteria, fungi,

parasites, viruses or prions.

Not all microorganisms cause

diseases but many can potentially

do so.

Parasites

(fleas, worms,

bedbugs)

misfolded

proteins (prions)

Spores of

Bacillus etc.

Bacteria Virus Others

Enterococcus

Staphylococcus

Streptococcus

Mykobacteria

Bacillus (aerobic)

Clostridia (anaerobic)

Candida

Aspergillus

Penicillium

HIV

Polio

Rota

Noro

Herpes

Fungi

Overview: Pathogens

Protozoa

Plasmodium

falciparum/

malariae

Transmission needs Circumstances

Airborne infection:

transmission through tiny secretion droplets, originating from human airways,

flying through the air and being inhaled by other people.

Smear infection:

indirect transmission by touching an object, which is contaminated with

infectious body secretions (e.g. saliva, urine, feces).

Contact infection:

transmission of infection from a sick individual to a healthy individual by direct

physical contact or touching contaminated materials or surfaces.

Medical Devices (MD) enable new surgical approaches

Hygiene belongs to Function

Preconditions to successful MD Processing

• MD are used in humans and thus can transmit infections.

• Nobody knows what happened to the processed, reusable MD so far.

• The individual’s actions are determined by their technical and hygienic knowledge

and understanding.

• There is a separate set of rules and regulations

Do we have suitable premises?

• Professional, competent and willing staff, professionally prepared for the MD.

• Procedural/work instructions (SOP “standard operating procedure”)

• Regular training and further education

• Appropriate work environment (room & equipment)

• Appropriate (validated) machine processes and/or standardized manual methods

• Processing on the actual level of science and technology (state of play)

• Gapless traceable documentation with available tracking technology

• Quality assurance system including evaluation of occurring risks

MD are a longterm Investment

MD are sometimes fine and complexe

Function requires Hygiene

Hygiene is part of a quality cycle:

What does (Re-)Processing of Medical Devices imply?

traceability

sterilize

waste use

stock

clean &

disinfect dry

inspect waste

sterilize

wrap &

label

raw

material

A Process oriented Quality Concept

Responsibility for Results

• Operator responsibility pertains to all services of a hospital or

other health care facility, which includes the processing of

medical devices (MD), usually carried out in a Sterile

Processing Department (SPD) or Central Sterile Supply

Department (CSSD) or Reprocessing Unit for Medical Devices

(RUMED).

• There is an obligation to actively request/seek out information

in order to keep up with current developments.

• The delegation of responsibilities (e.g. to service providers)

does not affect the responsibility for the results. The onus of

control is on the operator, within his stipulated mandate to

provide care.

• The manufacturer provides the necessary information for use

(IFU) and after sales services supporting the customer.

13

The Impact of Processing in Legal Terms

• The risks of reprocessing are considered to be „fullymanageable“.

• The incidence of nosocomial infections remains unclear, since they are difficult to trace back. Some of them (perhaps: 20-30%) could be prevented.

• „The hygiene- and sterilisation risk has to be kept to theinevitable residual risk, according to the state of science andtechnology.“ (from a verdict of German Federal Supreme Court [BGH])

• From a legal point of view, work in a CSSD is a task „of a higher degree“. This implies an obligation for the staff tofurther their education „to the limits of what can reasonably beexpected“ (quotations from relevant verdicts).

Task

(legal and standard conformous) processing of MD

Implementing

Laws, standards, guidelines, recommendations

Prior arts, state of technologies and sciences

Qualitiy Management establishment and practice

Evaluation of risks

Education and training

Goal

Safety of patients, staff and third parties

Aiming to lower residual risks

Job professionalism instead of „training on the job“

Medical Devices and Regulatory Affairs

Medical

Device

Regulation

(MDR)

Medical Device Act

Medical Device Operator

Ordinance – MPBetreibV

Accident Prevention Regulations

Recommendations, guidelines

Prior arts

(State of sciences and technologies)

standards (DIN, EN, ISO), guidelines,

recognized rules, recommendations

Pyramid of Regulatory Affairs

Global quality management

Risk evalution

Liability

https://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Hygiene_Requirements_Medical_Devices_2012.pdf?__blob=publicationFile

KRINKO

MD are in the Midst of Processes

MD often have a complex Design

Step by Step to hygienic Function:

Step by Step to hygienic Function:

Processing of medical devices

(instruments, endoscopes, and accessories)

Step by Step to hygienic Function:

Transport from OR to

CSSD

Recirculation for use

Un-clean

Sterile

Time (minutes)

5 60 5 15 30-60

Dry transport

Ultrasound

Dissasembly

Pre-washing

Automatized

Washing

Drying

Thermal Disinfection

Soft Packaging

Containers

Sterilisation

Steam

Formaldehyde

Ethylene

oxide

H2O2 „Plas a“

Clean

Inspection

Re-washing?

Repairs?

Maintenance

Assembly

The “Swiss cheese model”

After Surgery or Endoscopy…

MD ready for Processing?

Appropriate Working Spaces & Work Flow

No crossings between

clean and dirty

work

spaces/processes

Appropriate Equipment & Installations

- Sink

- Basins and tubs

- Sufficient working surfaces

- Leak tester

- Ultrasound (basin)

- Hand washing area

- Medical pressurized air pistol

MD design and manner of clinical use

(Spaulding classification 1968 - modified)

Contact to intact skin

Non-critical

Contact to mucousmembranes or unhealthy skin

Semi- critical

Penetration of skin

Contact with blood

critical

Processability of the MD

Thermostable

simple design

smooth massive surface

A

Thermostable

complexe structure, cavities,

difficult to access-surfaces, lumen

B

Thermolabile

C

MD are different

Processing is „Hands on“

Manual Processes are dangerous

Safeguard Measure Vaccination

Example: needlestick injuries (NSI)

• Needlestick injuries (NSI) are generally understood to be pricks, cuts and scratch injuries of the skin by needles, cannulas, scalpels or similarinstruments

• Needlestick injuries are among the most frequently occurring in clinical routine work accidents

• They are often not reported, the alleged true figure is between 50% and 90%

• In Europe the following pathogens pertain the greatest risk:Hepatitis C virus (HCV)Hepatitis B virus (HBV) (if no sufficient vaccination is provided)Human Immunodeficiency Virus (HIV)

Storage / Transport

Safe Transport

„one touch“

Procedures must be adapted to the Task

Cleaning is Disinfection

ISO/FDIS 17664: 2017

3.1 cleaning

Removal of contaminants to the extent necessary for further

processing or for intended use.

Note: Cleaning consists of the removal, usually with detergent

and water, of adherent soil (e.g. blood, protein substances and

other debris) from the surfaces, crevices, serrations, joints, and

lumens of a medical device by a manual or automated process

that prepares the items for safe handling and/or further

processing.

3.3 disinfection

Process to reduce the number of viable microorganisms to a

level previously specified as being appropriate for a defined

purpose

• Contact time (t)

• Temperature (T)

• Mechanics (M)

• Chemistry (Ch)

– Type of active component

– Concentration

– pH-value

Sinner Circle

Removal or inactivation of any contamination

Main agent is water, as means of transport.

And for rinsing in between…

Influencing Parameters

Drinking water may not contain potentially infectious

microorganisms, from the water company/utility to the tap.

Water availability and its quality may be problematic.

- Pipes not properly installed or maintenance problems

- Dead zones

- Flow speed too low

- Cold water close to hot water (not insulated)

Water Supply & Availability

Water Quality for Processing

Automated or manual cleaning/disinfection – wherever:

Drinking water quality required for cleaning and disinfectionsolutions (including precleaning, change of water, cleaning, and rinsing processes in between).

If possible use desalinated water1

To determine thermal or chemical disinfection:

Final rinse with desalinated water1

Manual disinfection with desalinated sterile water!

1 conductivity value <15µs (EN 285)

(Pre-) Cleaning

Manual

soaking

brushing

flushing

ultrasonic (pre)cleaning

Cleaning (AIR)

Automated/mechanized

washer disinfector

Automated Instrument

Reprocessor

Load Carriers are varying for specific MD

Program specifications

Pump pressure

MD load

Water quantities

Water quality

Wetting

Distribution of water

Spray arms‘ distribution and rotation

Nozzles‘ distribution and diameters

Temperature

Time

Cleaning agent

Many Parameter enable Cleaning

Wet Loads after thermal Disinfection (AIR)

Cleaning AER

Automated/

mechanized

washer

disinfector

Automated

Endoscope

Reprocessor

Cleaning and biocidal action

are separate steps

Cleaning, rinsing, biocidal action (“disinfection”) and final rinsing

with sterile desalinated water have to be executed separately!

Dis-infection by biocidal Action

Disinfection

Inactivation of infectious agents

by biocidal action (instead of

reduction/removal by cleaning)

Target: infection impossible!

Automated reprocessing

- Thermal disinfection

(≥90°C)

- Chemical disinfection

(≤60°C)

Disinfection manually or Device-supported

manual „automated“

Concentration

Immersion time

Rinsing / neutralization

Recommended detergents

Water Quality and Formation of Biofilms

Biofilms are developing from use to use depending on formation

of specific microorganisms at boundary layers, mainly in

aqueous systems often adherent to solid phases.

Biofilms consist of slime (film) that might cover bacteria, algae,

fungi, protozoes (some of which produce the slime).

Therefore cleaning by brushing is crucial. Disinfectants might

loose their biocidal effects, since the bacteria are protected by

the biofilm.

1. Cleanliness, dryness, changes (e.g. corrosion)

2. Oiling (joints, ratchets)

3. Assembly

4. Functional inspection

5. Packaging

Maintenance & Sterile Barrier System

Sterilization

• Steam Sterilization 132-137°C, 4-18 minutes

(preferred method where applicable)

• Low-temperature Sterilization max. 60°C

(thermolabile MD like flexible endoscopes)

– H2O2

STERRAD 100S, NX, 100NX

(Advanced Sterilization Products - ASP)

VPro, VPro Max (STERIS Corporation)

– Formaldehyde (FA)

– Ethylene Oxide (EO/EtO)

– STERIS System 1/1E (PAA)

Information for Use (IFU) e.g. Rigid Scope

● This processing step is part of the validated process.

○ This additional processing step may be optionally performed to support cleaning.

The sterilization procedure has been approved in terms of material compatibility, but its effectiveness must still

be validated by the on-site operator.

x This processing step must not be performed as it may cause damage.

How to process this rigid scope?

Processing Information e.g. Rigid Scope

Rigid Telescope

• Cleaning

Manual or automated

max. temperature 95°C (110°C for drying)

recommended chemicals

• Disinfection

Manual or automated

thermal/chemical disinfection process

• Maintenance

Clean optical surfaces with 70% alcohol (Ethanol / Isopropyl)

• Sterilization

Steam sterilization (in an „autoclave“) at 134 – 137°C

Alternatives: H2O2 (STERRAD / STERIS V-PRO), ETO, FA

Information for Use (IFU) e.g. Forceps

How to process the forceps?

● This processing step is part of the validated process.

○ This additional processing step may be optionally performed to support cleaning.

The sterilization procedure has been approved in terms of material compatibility, but its effectiveness must still

be validated by the on-site operator.

x This processing step must not be performed as it may cause damage.

Processing Information e.g. Forceps

MIS-Instrument (ClickLine)

• Preparation

Disassembling

Brushing inner lumen, outer surfaces / flushing channels

• Cleaning

Manual or automated thermal disinfection process

• Disinfection

(Manually or) automated

• Maintenance

Functionality check

• Sterilization

Steam sterilization (autoclave) at 134 – 137°C

Thermolabile methods are regarded as second best

Processing Information for Flexible Scope

Flexible Endoscope (Fiberscope / Video-Endoscope)

• Preparation

Leakage test, brushing channels, wipe surfaces

• Cleaning

Manually or automated

max. temperature 65°C !!

recommended chemicals

• Disinfection

Manual or automated chemical disinfection process

• Maintenance

Clean optical surfaces with 70% alcohol (Ethanol/Isopropyl)

Leakage test

• Sterilization

Low temperature processes: (IFU)

H2O2 (STERRAD / STERIS V-PRO), ETO, FA

Helpful Information for Use (IFU)

KARL STORZ

• Training Manual

• General Reprocessing Instructions

Internet Information available

Helpful Tools

KARL STORZ

Hygiene Catalogue

Helpful Validation of MD and Materials

KARL STORZ

Material compatibility list

Please do not ship your scope like this!

Pitfalls & Failures

Impressive Impressions

Pooling

Leakage/

Water

penetration

Tasteful Impression

Once bitten twice shy

The Spectrum of Disinfectants

A killing vegetative bacteria, mycobacteria, fungi & fungal spores

B inactivating viruses

C killing anthrax spores

D killing clostridia spores

Bactericide = inactivating bacteria

Fungicide = inactivating fungi

Virucidal = inactivating virus (B)Coated viruses are surrounded by a lipid membrane (e.g. HBV, HCV and HIV,

and influenza viruses). The lipid membrane is fragile and can be destroyed

with alcohol. Coated viruses can be killed with disinfectants, which have a

limited virucidal activity spectrum (A).

Not coated viruses are not surrounded by a membrane coat (e.g. noro- or

rotavirus). Not coated viruses have a higher resistance to chemical, physical

processes and other environmental influences and may require the use of

particularly powerful disinfectants, which are declared as virucidal (B).

Personal Protective Equipment (PPE)

All products have to adhere to the relevant standards

• Hair Covering

• Eye protection such as goggles or glasses with solid side

shields

• Respiratory protective face mask

• Gloves

• Apron/gown with reinforced sleeves that acts as a barrier to

fluids

• Skid-resistant, antistatic footwear

Which Areas to disinfect?

• Surfaces with frequent skin-

or hands-contact like door

handles, handrails,

keyboards, phone

• Treatment and patient-

friendly surfaces like

medical equipment, dental

chair, couch, bedside table,

bed frame

• Surfaces in communally

used sanitary areas like

toilets, showers, tubs, sinks

• all sorts of working surfaces

Hygiene is prevention. Prevention is more than disinfection!

• Sufficient and appropriate medical devices (MD)

• Equipment for processing (tools, quality/quantity of machinery)

• (Further) education/training (general/technical knowledge)

• Processes (parametric release, verification & validation)

• Acceptance criteria (countable, „narratable“)

• Processing „by the book“ (standards, regulation)

Documentation > Evaluation of risks > Quality management

Problems > Tasks > Solutions

The PDCA-Cycle (Deming)

It is in your hands

Hygiene is Function is Prevention is Safety