A clear choice in Urinary Infection Prevention PVC … · The design features of the new Uro-Tainer® PVC-free bags help improve handling and safety16 Uro-Tainer® PVC-free bags have

Catheter Maintenance with Uro-Tainer® PVC-free Improving Patient Quality of Life

A clear choice in Urinary Infection Prevention

Edition October 2014

PVC (polyvinyl chloride) is the third most widely used plastic worldwide after polyethylene and polypropylene, with 4.9 million tonnes produced in Europe each year1. PVC is used across a wide range of industrial sectors including construction, transport, packaging, electronics and healthcare (Fig 1). It is a popular material due to its relatively low cost, biological and chemical resistance, longevity and versatility1.

The rigid form of PVC is used in construction for pipes, windows and doors1. It is also used for bottles, non-food packaging, children’s toys, home furnishings, car parts and bankcards1. It can be made softer and more flexible by the addition of plasticizers, the most widely used being phthalates1. In this form, it is also used in plumbing, electrical cable insulation, signage, inflatable products and medical devices1.

What is PVC and what kind of products is it used for?

Contents

What is PVC and what kind of products is it used for?

Why are there concerns about the use of PVC?

Why PVC-free?

B. Braun – product sustainability and innovation

Uro-Tainer® PVC-free

Step 1 – Patient Selection and Monitoring

Step 2 – Uro-Tainer® Solution Selection

Uro-Tainer® Practical Aspects

Uro-Tainer® Overview

Uro-Tainer® - Leading the way in catheter maintenance

References

Construction

Other inc medical

Packaging

Automotive

Electrical /electronic

Figure 1: PVC use areas in Europe1

Health issuesThere has been growing concern about the health impact of PVC products due to the release of potentially toxic chemicals into the environment during their manufacture, use and disposal2,3. In particular the safety of phthalate plasticizers such as DEHP (di-2-ethylhexyl phthalate) has been the focus of consumer groups and the scientific community as

■ Phthalates are very susceptible to leaching into the environment from the PVC as they are not tightly bound to the polymer2,4

■ Some types of phthalates such as DEHP are thought to have the potential to be ‘endocrine disruptors’ and have been shown to adversely affect the reproductive system of laboratory animals5,6

■ Certain groups such as young children seem to be at higher risk of exposure to phthalates due to their hand to mouth behaviours7. Neonates treated in intensive care are particularly susceptible to phthalate exposure due to invasive use of PVC products4

■ Critically ill or injured patients may be at increased risk of developing adverse health effects from DEHP8

Despite the high level of consumer concern investigations by government authorities in the US and Europe have found no convincing evidence of the adverse effects of phthalates in the general population8. In order to reduce the risk of exposure to phthalates in high-risk groups the European Union (EU)

Why are there concerns about the use of PVC?

banned the use of DEHP in all children’s toy products in 19997. In 2008 the US government followed suit and banned the manufacture or import of children’s toys containing more than 0.1% DEHP9. In 2010 the EU also introduced specific labeling requirements for all devices containing phthalates such as DEHP to enable healthcare professionals to use this type of equipment safely in patients at risk of over-exposure10.

Individual healthcare providers have responded to the concerns about PVC in medical devices. The Glanzing Clinic in Austria became the world’s first paediatric healthcare provider to eliminate all invasive use of PVC in 200311. In January, 2012 a major US healthcare provider, Kaiser Permanente, announced that it would no longer buy intravenous (IV) medical equipment made with PVC and DEHP type plasticizers11. Many hospitals in Europe have now begun taking steps to eliminate PVC11. These include countries well known for their environmental programmes such as Sweden as well as the Czech Republic and Slovakia11.

Environmental issuesThere are also concerns about the environmental effects of the production and disposal of PVC products. PVC products do not biodegrade easily and given the large volumes involved this means that landfill is not a sustainable option for disposal12. Moreover additives such phthalates and heavy metals can leach out of landfilled PVC and have the potential to contaminate ground water12. Burning PVC adds to the environmental burden of carcinogenic chemicals such as dioxin and hydrochloric acid12. Recycling is theoretically possible, however, the process of recycling is also associated with increased emission of toxic chemicals; it is relatively expensive and the market for recycled PVC is relatively small12.

In response to these health and environmental concerns PVC products softened with plasticizers other than DEHP (e.g. citrates and adipates) are also available on the market13. However, many of these chemicals are like DEHP, in that they all have the potential to leach out of devices and into patients13. The potential health risks of DEHP alternatives are largely unknown, due to the lack of toxicological data publicly available on these softeners13. Furthermore the use of alternative softeners does not eliminate the environmental problems associated with the manufacture and disposal of PVC13.

There are now many PVC-free materials available, suitable for a wide variety of medical applications, which do not require phthalates or other softeners13. The potential hazards posed by phthalates leaching from equipment and being carried into the patient can therefore be avoided13. Furthermore, since the alternatives are not made from PVC, they can be more easily recycled, eliminating the problems associated with disposal of PVC medical equipment13. As well as being PVC-free these products can also have additional benefits13. For example PVC-free IV bags do not stiffen with use, as softeners are not removed from the plastic by the bag contents13.

Why PVC-free?

B. Braun

■ Selects environmentally friendly raw materials for new products14

■ Is constantly improving formulations in order to provide an environmentally friendly product portfolio14

■ Utilizes PVC-free packaging materials

■ Minimizes the weight of packaging materials in order to increase environmental sustainability14

■ Utilises a state of the art safety management system which guarantees a uniformly high level of quality, from product conception to dispatch14

■ Helps to improve treatments and working procedures in hospitals and medical practices and to increase the safety of patients, doctors and nursing staff by

− Being a reliable partner by implementing the EU Directive 2010 / 32 / EU14

− Supporting customers through the built in safety of our innovative product systems14

− Delivering safety data sheets for all products14

B. Braun – product sustainability and innovationB. Braun is constantly working to improve the environmental credentials of their products and packaging14. B. Braun is also continuously expanding the product range to offer more choice, to meet new consumer requirements as well as optimising the usability and safety of existing products14.

Beginning at the product development stage, environmentally compatible design, technical safety

and health protection are fixed as targets14

B. Braun Infection Control – Responsibility & Sustainability Strategy 2013

“

”

In November, 2005 one of the largest hospital networks in the US Catholic Healthcare West, signed a contract with B. Braun

Melsungen to supply PVC-free IV bags and tubing15.

B. Braun have set a new standard by being the first company in the field to introduce PVC-free bags for the Uro-Tainer® catheter maintenance system16. Uro-Tainer® is the only product of its kind to be manufactured without

■ Polyvinyl chloride (PVC)

■ The phthalate plasticizers - di-[2-ethylhexyl]phthalate (DEHP) and Bisphenol A (BPA)

■ Latex

The new Uro-Tainer® PVC-free ■ Bags are manufactured from Nexcel® M312A16

■ Flexible tube and urologic closure are manufactured from polypropylene (PP)16

Nexcel® M312A (Figure 2) is a polyolefin film which is sterilizable at 120 °C and has excellent clarity, flexibility and durability. Nexcel® M312A is designed to be chemically inert and to have low levels of extractables with a wide range of solutions even when sterilized at 120 °C.17. These properties make it ideal for use in medical applications such as the Uro-Tainer® catheter maintenance system16,17.

Polyolefins including polypropylene are more sustainable manufacturing materials compared to PVC. They are 100 % recyclable and due to the wide number of applications for polyolefins there is also a high demand for recycled product18

Uro-Tainer® PVC-free

The performance of the new Uro-Tainer® PVC-free is comparable to the existing product16.

Figure 2: Nexcel® M132A

The design features of the new Uro-Tainer® PVC-free bags help improve handling and safety16

Uro-Tainer® PVC-free bags have improved shelf-life to help reduce wastage16

Improved handling & feel

Improved administration & safety

Design features

Figure 2: Nexcel® M132A

Softer plasticImproves the feel of the product for the patient

Greater bag transparencyEasier to assess colour of the urine and observe debris

Insertion of hanger for the Uro-Tainer® MEnables easier administration of drugs

Improved seal for the Uro-Tainer® M injection portEnsures one-way flow

Colour-coded conus and clampImproves identification in a busy working environment

Same flow rate as original productNo change in technique required

New clamp designEnables one-handed operation

Drugs databaseEnables healthcare professionals to assess compatibility of drugs used in combination with Uro-Tainer®

Step 1 - Patient Selection and Monitoring■ Encrustation and blockage of indwelling urinary catheters is a common

problem affecting up to 50 % of catheterized patients19

■ For the purposes of management catheter wearers can be categorised as ‘blockers’ or ‘non-blockers’19

■ ‘Blockers’ typically

− Excrete more alkaline urine (high pH >) containing less phosphate, urea and magnesium and are19

− Have two or more blocked catheters within a 6 week period19

− Female with poor mobility19

■ For patients based in the community the resulting urinary bypassing or retention is especially distressing as professional help is not immediately available19

− In a UK survey of 467 catheterized patients, catheter-associated complications resulted in over 500 emergency referrals during a six-month period20

■ Catheter removal may be the only management option for catheter blockage and recurrent infection21

■ Fequently changing an indwelling catheter may lead to increased risk of infection and further discomfort and embarrassment for the wearer22,23

■ Therefore there is a strong rationale for a catheter maintenance strategy, which will help prevent the development of catheter-associated complications and frequent removal

Uro-Tainer®50 % of catheterized patients affecteddue to encrustation and blockage of indwelling urinary catheters19

Catheter wearers can be categorised as

A catheter maintenance strategy will help prevent the development of catheter-associated complications

A survey of 467 catheterized patients, catheter-associated complications resulted in over 500 emergency referrals during a six-month period22,23

Catheter

maintenance strategy

BLOCKERS

UK SURVEY

NON-BLOCKERS

CSU:

Catheter diary

No

Catheter

change date:

Reason for change: Routine Fallen Out

Yes

No

Baloon Burst Blocked

Comments/ problems:

Catheter maintenance solutions/ antibiotic therapy details:

Name of nurse/ doctor/ carer:

D. Blackberry

Date of next catheter change:

30th September

Insertion easy

(yes/no):

L

Role of the catheter diary■ A catheter diary is a helpful monitoring tool for catheterized patients. It can

help all the healthcare professionals involved with the patient to highlight any problems with the catheter at an early stage and initiate a suitable management plan

■ The diary enables the monitoring of the catheter lifespan and any contributing factors to blockage e.g. infection etc

■ A clear picture of the catheter’s lifespan is usually evident after three to five catheters are evaluated24

Blockages resulting from calcification and encrustation can usually be identified using a catheter diary in conjunction with a combination of:

■ pH-indicator - Check urine pH regularly since alkaline urine (indicated by pH > 6.8) is a strong indication of possible calcification (64). pH can be measured using pH strips

■ Culture - Bacteria in the urine, such as Proteus mirabilis, in combination with alkaline urine create ideal conditions for the onset of calcification

■ Inspection - If it is suspected that a blockage has resulted from calcification, checking the catheter by cutting it open along its length after it has been removed is recommended. If the catheter is blocked and the blockage cannot be attributed to calcification this is a good indication that debris formation is the cause of the blockage

Monitoring

Catheter blockage can result from a number of different causes. Therefore, discovering the exact cause of the blockage is important as this influences the choice of treatment approach. If the useful life of the catheter is threatened by encrustation or debris formation, intervention with the correct Uro-Tainer® rinse fluid, in addition to a healthy diet and sufficient fluid intake, can increase the catheter’s lifespan24

CSU:

Catheter diary

20th SeptemberNo

Catheter change date:

Reason for change: Routine Fallen Out

Yes

No

Baloon Burst Blocked

Comments/ problems: This is the third time the catheter has blocked in 6 weeks – advise catheter maintenance to be initiated. No evidence of infection. pH of urine 7.4

Catheter maintenance solutions/ antibiotic therapy details: Uro-Tainer Suby G initiated 21st September.

Name of nurse/ doctor/ carer: D. BlackberryDate of next catheter change: 30th September

Insertion easy (yes/no):

L

L

CATHETER IN SITU

ELIMINATE SIMPLEMECHANICAL OBSTRUCTION

CHECK:VISCOSITYCOLOUR OF URINEpHDEBRISBLADDER SPASM

CONSTIPATION

KINKED TUBING

RESTRICTIVE CLOTHING

OVER-FULL & MALPOSITIONEDDRAINAGE BAGS

YES YES

CHECK pH TWICE WEEKLY

CRANBERRY JUICE/CAPSULES

ESTABLISH CATHETER LIFE

CRYSTALS IDENTIFIED

PERSISTENT BLOCKERSpH > 7.7

USE URO-TAINER® TWIN SUBY G

USE URO-TAINER® TWIN SOLUTION R

pH > 6.8

1st choice

ESTABLISH HISTORY WITH CATHETER DIARY

DRAINAGE PATTERN

DRAINING WELL PROBLEM

CONSERVATIVE MANAGEMENT

RECURRENT BLOCKAGE

PHYSICAL EXAMINATIONOF CATHETER LUMEN

NO YES

USE URO-TAINER® NaCl 0.9%

Uro-Tainer® Practical AspectsThe Uro-Tainer® sachet is supplied sterile and should not be removed from its overwrapping until required for use. If desired, bring solution to body temperature by immersing the wrapped sachet in warm water.

Holding the Uro-Tainer® above the level of the bladder.

Release the clamp to allow the fluid to drain in by gravity.

When the fluid has stopped draining in (this takes a few minutes), lower the Uro-Tainer® below the level of the bladder to drain fluid back into the bag.

Clamp tube and remove the connector from the catheter by turning gently. Connect the catheter to a sterile drainage bag. Dispose of Uro-Tainer® sachet and wash hands.

Tear open overwrapping and remove Uro-Tainer® sachet.

Close Uro-Tainer® tube with plastic clamp.

Remove tamper proof seal.Twist and withdraw cap without touching sterile connector.

Insert connector into the catheter funnel.

Step 1

Step 2

Step 3

Step 4

Step 5

Step 6

Do not re-use for single use only. Discard properly after use.

Step 7

Step 8

Step 2 - Patient Selection and Monitoring

HELPLINE NUMBER: 0800 526 116

NURSE ADVISOR:

Uro-Tainer® Solution

Uro-Tainer® Suby GIndication: A mildly hypotonic fluid that is less irritating as a result of the addition of magnesium. This fluid is specially designed to prevent phosphate crystallization and dissolve existing calcification in indwelling catheters.

Rinse frequency: 2 to 3 times per week depending on the scope of the problem, unless prescribed differently by the doctor. The fluid must remain in the bladder for 5 minutes.

Composition: Per 100 ml: citric acid monohydrate 3.23 g, mild magnesium oxide, 0.38 g, sodium bicarbonate 0.7 g, edetate disodium 2H2O 0.01 g in water for injection. pH=4.2

Uro-Tainer® Solutio RIndication: A mild hypotonic fluid that is specially designed for catheters with stubborn calcification where Suby G does not provide a sufficient result. This is due to its higher concentration of citric acid and gluconolactone. In addition, this fluid minimizes trauma when removing an indwelling catheter.

Rinse frequency: 2 to 3 times per week depending on the scope of the problem, unless prescribed differently by the doctor. The fluid must remain in the bladder for 5 minutes.

Composition: Per 100 ml: citric acid monohydrate 6.0 g, gluconolactone 0.6 g, mild magnesium carbonate 2.8 g, edetate disodium 2H2O 0.01 g in water for injection. pH = 4

Uro-Tainer® NaCl 0.9 %Indication: This isotonic fluid is used primarily for cleaning the bladder and catheters mechanically, e.g. in the case of debris formation in the bladder.

Rinse frequency: 1 to 2 times per day depending on the scope of the problem, unless prescribed differently by the doctor.

Composition: Sodium chloride 0.9 %. pH=7

50 ml

100 ml

60 ml (Twin)

Size

FB99851

FB99839

9746609

10

10

10

Catalogue number

Order quantity

50 ml

100 ml

60 ml (Twin)

FB99843

FB99841

9746625

10

10

10

50 ml

100 ml

50 ml + injection port

100 ml + injection port

FB99849

FB99833

FB99854

FB99853

10

10

10

10

Contraindications: Do not use Uro-Tainer® in cases of hypersensitivity to any of the ingredients of the solution (see section 6 of the instructions for use); in case of cystitis or any other uro-genital condition that can produce haematuria (blood in the urine); for several days after surgery on the bladder or urinary tract and for patients with spinal injuries because of the risk of autonomic dysreflexia.

Uro-Tainer® - Leading the way in catheter maintenance■ Uro-Tainer®

− is the only catheter maintenance system of its kind, which is PVC and phthalate free

− provides safe and effective bladder instillations

■ Contamination is minimised and product safety enhanced as

- The universal catheter tip is sterile and has an attached protective cap

- It is a completely closed system

- The exterior of the device is sterile when the package is opened and it is ready to use

■ Patient comfort and safety is maximized

- The device has a simple and safe operating mode with new design features

- It can be easily used by healthcare professionals as well as the patient

References:

1. PVC Plus. Everything about PVC from manufacturing to recycling. Available at www.renolit.com. Last accessed 03.09.14.

2. Bornehag CG, Sundell J, Weschler CJ et al. The Association between asthma and allergic symptoms in children and phthalates in house dust: A nested case–control study”. Environ Health Perspect 2004; 112 (14): 1393–1397.

3. Rigo, HG, Chandler AJ, Lanier WS. (1995). The relationship between chlorine in waste streams and dioxin emissions from waste combustor stacks. American Society of Mechanical Engineers Report CRTD 36, 2005 (New York, NY: American Society of Mechanical Engineers). ISBN 0-7918-1222-1227.

4. Green R, Hauser R, Calafat AM et al. Use of di (2-ethylhexyl) phthalate–containing medical products and urinary levels of mono(2-ethylhexyl) phthalate in neonatal intensive care unit infants. Environ Health Perspect 2005; 113: 1222–1225.

5. Albert O, Jégou B. A critical assessment of the endocrine susceptibility of the human testis to phthalates from fetal life to adulthood. Hum Reprod Update 2014; 20(2): 231-249.

6. Hallmark N, Walker M, McKinnell C, et al. Effects of monobutyl and di(n-butyl) phthalate in vitro on steroidogenesis and leydig cell aggregation in fetal testis explants from the rat: Comparison with effects in vivo in the fetal rat and neonatal marmoset and in vitro in the human. Environ Health Perspect 2007; 115 (3): 390–396.

7. European Union. Ban of phthalates in childcare articles and toys. Press release IP/99/829, Brussels, 10 November 1999. Available at http://europa.eu/rapid/ press-release_IP-99-829_en.htm?locale=en. Last accessed 03.09.14.

8. Food and Drug Administration. Safety assessment of di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices. Available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080457.pdf. Last accessed 03.09.14.

9. GovTrack.us. H.R. 4040--110th Congress (2007): Consumer Product Safety Improvement Act of 2008. Available at https://www.govtrack.us/congress/bills/110/hr4040#summary. Last accessed 03.09.14.

10. European Commission. DIRECTIVE 2007/47/EC AMENDING DIRECTIVES 90/385/EEC, 93/42/EEC AND 98/8/EC. Available at http://www.mhra.gov.uk/home/groups/es-era/documents/regulatorynews/con049176.pdf. Last accessed 03.09.14.

11. Health and Environment Alliance. Avoiding PVC use in Hospitals. Available at http://www.env-health.org/IMG/pdf/PVC_in_hospitals.pdf. Last accessed 03.09.14.

12. Greenpeace. What’s wrong with PVC? Available at http://www.greenpeace.org.uk/MultimediaFiles/Live/FullReport/5575.pdf. Last accessed 03.09.14.

13. Health Care Without Harm. PVC Alternatives. Available at https://noharm-uscanada.org/content/europe/pvc-free-alternatives. Last accessed 03.09.14.

14 B. Braun Infection Control. Responsibility and sustainability strategy. Available at http://www.bbraun.com. Last accessed 03.09.14.

15. Safer Chemicals, Healthy Families. Catholic Healthcare West. Healthy Chemicals, Healthy Patients - Why health care needs federal chemicals reform. Available at http://saferchemicals.org/get-the-facts/business-case-studies/catholic-healthcare-west-case-study-healthy-chemicals-healthy-patients-why-health-care-needs-federal-chemicals-reform/. Last accessed 03.09.14.

16. B. Braun . Regulatory submission technical file. Document N° TF-IIa-2.7-UTX. Data on file.

17. Sealed Air Medical. Nexcel® Pharmaceutical Films. Available at http://www.sealedairmedical.com/na/en/Nexcel_Pharma/M312-312A-312C.aspx. Last accessed 03.09.14.

18. Plastics Europe. Polyolefin recycling. Available at http://www.plasticseurope.org/information-centre/press-releases/press-releases-2011/polyolefins-100-diversion-from-landfill-is-possible-says-plasticseurope.aspx. Last accessed 03.09.14.

19. Getliffe KA. The characteristics and management of patients with recurrent blockage of long-term urinary catheters. J Adv Nurs 1994; 20: 140-149.

20. Kohler-Ockmore J, Feneley RC. Long-term catheterization of the bladder: prevalence and morbidity. Br J Urol 1996; 77 (3): 347-351.

B. Braun Medical AG | Seesatz 17 | 6204 Sempach | Switzerland | www.bbraun.com IC

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