Perspectives on PVC in Medical DevicesPerspectives on PVC in Medical Devices

Ole Grøndahl HansenOle Grøndahl Hansen

PVC Information Council DenmarkPVC Information Council Denmark

www.pvc.dkwww.pvc.dk

Plastics in Medical Devices ConferencePlastics in Medical Devices Conference

Brussels 23 April 2009Brussels 23 April 2009

Content of presentationContent of presentation General introduction to PVC in medical applicationsGeneral introduction to PVC in medical applications

PVC vote in the European ParliamentPVC vote in the European Parliament

Vinyl 2010 – key achievements 2000-2008Vinyl 2010 – key achievements 2000-2008

DEHP in medical devices – outcome of political discussionsDEHP in medical devices – outcome of political discussions

Eco-labelling of medical devices – based on science?Eco-labelling of medical devices – based on science?

PVC medical applications at medical museumPVC medical applications at medical museum

ConclusionsConclusions

others 11%

PP 13%

PS 21%PE 29%

PVC 29%

Use of plastics in the health care sector

85.000 tonnes of PVC used for medical devices per year in EU

Total consumption of PVC in Europe is 7.000.000 tonnes

PVC medical applicationsPVC medical applicationsThe low costs and the high performance of PVC made it The low costs and the high performance of PVC made it possible to manufacture single-use devices in the late 1950’s.possible to manufacture single-use devices in the late 1950’s.

The two main application areas for PVC devices are flexible The two main application areas for PVC devices are flexible containers and medical tubing: ie. urine bags, ostomy bags, containers and medical tubing: ie. urine bags, ostomy bags, blood bags etc and different kinds of tubing for catheters etc.blood bags etc and different kinds of tubing for catheters etc.

Single-use of medical devices resulted in a revolution within Single-use of medical devices resulted in a revolution within the health care sector. The PVC based devices improved the health care sector. The PVC based devices improved medical safety by reducing the risk of life-threatening medical safety by reducing the risk of life-threatening infections caused by the multiple-use of traditional devices.infections caused by the multiple-use of traditional devices.

New knowledge and new New knowledge and new technology changed the debatetechnology changed the debate

THEN:THEN:In the past badly driven hospital incinerators caused acid rain and In the past badly driven hospital incinerators caused acid rain and dioxin emissions. This was partly due to the chlorine content in the dioxin emissions. This was partly due to the chlorine content in the hospital waste. Although PVC is only one of the contributors of chlorine hospital waste. Although PVC is only one of the contributors of chlorine PVC was accused of being the main cause of these emissions.PVC was accused of being the main cause of these emissions.

NOW:NOW:Because of new incineration technologies and more stringent Because of new incineration technologies and more stringent regulations, PVC no longer plays any role in the creation of acid rain regulations, PVC no longer plays any role in the creation of acid rain and cannot be accused of being the cause of dioxin emissions. The and cannot be accused of being the cause of dioxin emissions. The dioxin debate during the last ten years showed that the role of PVC is dioxin debate during the last ten years showed that the role of PVC is inferior to incinerator design and operating conditions in the creation inferior to incinerator design and operating conditions in the creation of dioxins from waste incinerators.”of dioxins from waste incinerators.”

The concern of dioxin in association with the incineration of medical The concern of dioxin in association with the incineration of medical devices has diminished dramatically during the last ten years. This is devices has diminished dramatically during the last ten years. This is partly because of new scientific knowledge, partly because of the use partly because of new scientific knowledge, partly because of the use of new incineration technology. However, neutralisation residues of new incineration technology. However, neutralisation residues resulting from PVC incineration are still of concern to some resulting from PVC incineration are still of concern to some stakeholders.stakeholders.

EU-Parliament voteEU-Parliament vote

In 2007 there is a vote on PVC in the European Parliament. 662 vote against a PVC directive, while 17 vote for. PVC is not an issue anymore in the European Parliament. According to the EU Commission, the reason is the industry’s voluntary committment: Vinyl 2010

Vinyl 2010 Vinyl 2010 Some key achievements 2000-2008Some key achievements 2000-2008

Post consumer recycling reaches 194,950 tonnesPost consumer recycling reaches 194,950 tonnes

Reduction in lead stabilisers (50% reached two Reduction in lead stabilisers (50% reached two years ahead of schedule)years ahead of schedule)

Cadmium stabilisers phase-out in EU 27Cadmium stabilisers phase-out in EU 27

Phthalate risk assessments completed and Phthalate risk assessments completed and publishedpublished

Bisphenol-A phase out of PVC resin productionBisphenol-A phase out of PVC resin productionFrom Vinyl 2010 Progress report 2009

Outcome of Political Outcome of Political DiscussionsDiscussions

Revision of Medical Device DirectiveRevision of Medical Device Directive

Politicians inspired by the directive on toys Politicians inspired by the directive on toys

Environmental Committee voted for a ban of CMR-Environmental Committee voted for a ban of CMR-substances in medical devicessubstances in medical devices

Compromise between EU-Commission, the Council and Compromise between EU-Commission, the Council and approved by European Parliament: 645 voted for the approved by European Parliament: 645 voted for the proposal, 15 against.proposal, 15 against.

Result: Labelling of CMR classified phthalates. Labelling Result: Labelling of CMR classified phthalates. Labelling procedure delayed. procedure delayed.

www.dehp-facts.com provides more detailed and up to date information.

Nordic Swan eco-label

Ecolabel on a medical Ecolabel on a medical devicedevice

Nordic Swan label on a dialyse bag is from 2008 possibleNordic Swan label on a dialyse bag is from 2008 possible

Criteria: The device must be PVC and phthalate freeCriteria: The device must be PVC and phthalate free

Industry answer to the label:Industry answer to the label:

Criteria based on outdated literature. (See Medtec Insider Criteria based on outdated literature. (See Medtec Insider dec. 08)dec. 08)

The only LCA analysis on medical device concludes otherwise The only LCA analysis on medical device concludes otherwise than the Swan secretariat does. (H. Stripple et al 08)than the Swan secretariat does. (H. Stripple et al 08)

PVC in modern day surgery

PVC at Medical History PVC at Medical History MuseumMuseum

In May 2008 the Plastic Fantastic exhibitionopened at the Thackray Medical HistoryMuseum in Leeds, UK. Sponsored by Ineos.

At the exhibition the story of modern day surgery told through PVC and plastics is being told.

The main focus of the museum - which is one of the largest medical history museums in Europe - is surgery and the development of public health since the 19th century. On average 75,000 people visit the museum every year.

1. Non transparent rubber tubing 2. Kinking tubing3. Container made in fragile glass4. Multiple use device5. Expensive6. Big and heavy device7. Difficult to sterilise8. Complicated to manufacture 9. Complicated to use

Old blood transfusion set

Adolf Hitler’s blood transfusion set from 1940s at the Thackray Medical Museum

Modern transfusion setModern transfusion set

1. Transparent tubing1. Transparent tubing 2. Container in non-fragile 2. Container in non-fragile

plasticsplastics 3. Single use3. Single use 4. Cost effective4. Cost effective 5. Light weight5. Light weight 6. Non-kinking PVC- tubing6. Non-kinking PVC- tubing 7. Easy to sterilise7. Easy to sterilise 8. Ease of fabrication8. Ease of fabrication 9. Easy to use9. Easy to use

Next to Hitler’s transfusionset is shown a modernset in PVC

A ten minutes long video interview with chief executive, Almut Grüner, is available on different websites across the world:

www.pvc.dkwww.pvc.org

www.pvcplus.de

ConclusionsConclusions PVC is widely used in medical applicationsPVC is widely used in medical applications

European Parliament positive vote on PVC in 2007European Parliament positive vote on PVC in 2007

Vinyl 2010 is making progressVinyl 2010 is making progress

DEHP under pressure in medical applications – label DEHP under pressure in medical applications – label requiredrequired

Eco-labelling based on antiquated scienceEco-labelling based on antiquated science

Positive aspects of PVC in medical devices for the first time Positive aspects of PVC in medical devices for the first time on display on medical museumon display on medical museum