Perspectives on PVC in Medical Devices Ole Grøndahl Hansen PVC Information Council Denmark Plastics in Medical Devices Conference Brussels 23 April 2009

Content of presentation General introduction to PVC in medical applications General introduction to PVC in medical applications PVC vote in the European Parliament PVC vote in the European Parliament Vinyl 2010 – key achievements Vinyl 2010 – key achievements DEHP in medical devices – outcome of political discussions DEHP 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 museum PVC medical applications at medical museum Conclusions Conclusions

others 11% PP 13% PS 21% PE 29% PVC 29% Use of plastics in the health care sector tonnes of PVC used for medical devices per year in EU Total consumption of PVC in Europe is tonnes

PVC medical applications The low costs and the high performance of PVC made it possible to manufacture single-use devices in the late 1950s. The two main application areas for PVC devices are flexible containers and medical tubing: ie. urine bags, ostomy bags, blood bags etc and different kinds of tubing for catheters etc. Single-use of medical devices resulted in a revolution within the health care sector. The PVC based devices improved medical safety by reducing the risk of life-threatening infections caused by the multiple-use of traditional devices.

New knowledge and new technology changed the debate THEN: In the past badly driven hospital incinerators caused acid rain and dioxin emissions. This was partly due to the chlorine content in the hospital waste. Although PVC is only one of the contributors of chlorine PVC was accused of being the main cause of these emissions. NOW: Because of new incineration technologies and more stringent 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 dioxin debate during the last ten years showed that the role of PVC is inferior to incinerator design and operating conditions in the creation of dioxins from waste incinerators. The concern of dioxin in association with the incineration of medical devices has diminished dramatically during the last ten years. This is partly because of new scientific knowledge, partly because of the use of new incineration technology. However, neutralisation residues resulting from PVC incineration are still of concern to some stakeholders.

EU-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 industrys voluntary committment: Vinyl 2010

Vinyl 2010 Some key achievements Post consumer recycling reaches 194,950 tonnes Post consumer recycling reaches 194,950 tonnes Reduction in lead stabilisers (50% reached two years ahead of schedule) Reduction in lead stabilisers (50% reached two years ahead of schedule) Cadmium stabilisers phase-out in EU 27 Cadmium stabilisers phase-out in EU 27 Phthalate risk assessments completed and published Phthalate risk assessments completed and published Bisphenol-A phase out of PVC resin production Bisphenol-A phase out of PVC resin production From Vinyl 2010 Progress report 2009

Outcome of Political Discussions Revision of Medical Device Directive Revision 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-substances in medical devices Environmental Committee voted for a ban of CMR-substances in medical devices Compromise between EU-Commission, the Council and approved by European Parliament: 645 voted for the proposal, 15 against. Compromise between EU-Commission, the Council and approved by European Parliament: 645 voted for the proposal, 15 against. Result: Labelling of CMR classified phthalates. Labelling procedure delayed. Result: Labelling of CMR classified phthalates. Labelling procedure delayed. provides more detailed and up to date information.

Nordic Swan eco-label

Ecolabel on a medical device Nordic Swan label on a dialyse bag is from 2008 possible Nordic Swan label on a dialyse bag is from 2008 possible Criteria: The device must be PVC and phthalate free Criteria: The device must be PVC and phthalate free Industry answer to the label: Criteria based on outdated literature. (See Medtec Insider dec. 08) Criteria based on outdated literature. (See Medtec Insider dec. 08) The only LCA analysis on medical device concludes otherwise than the Swan secretariat does. (H. Stripple et al 08) The only LCA analysis on medical device concludes otherwise than the Swan secretariat does. (H. Stripple et al 08)

PVC in modern day surgery

PVC at Medical History Museum PVC at Medical History Museum In May 2008 the Plastic Fantastic exhibition opened at the Thackray Medical History Museum 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 tubing 3. Container made in fragile glass 4. Multiple use device 5. Expensive 6. Big and heavy device 7. Difficult to sterilise 8. Complicated to manufacture 9. Complicated to use Old blood transfusion set Adolf Hitlers blood transfusion set from 1940s at the Thackray Medical Museum

Modern transfusion set 1. Transparent tubing 1. Transparent tubing 2. Container in non-fragile plastics 2. Container in non-fragile plastics 3. Single use 3. Single use 4. Cost effective 4. Cost effective 5. Light weight 5. Light weight 6. Non-kinking PVC- tubing 6. Non-kinking PVC- tubing 7. Easy to sterilise 7. Easy to sterilise 8. Ease of fabrication 8. Ease of fabrication 9. Easy to use 9. Easy to use Next to Hitlers transfusion set is shown a modern set in PVC

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

Conclusions PVC is widely used in medical applications PVC is widely used in medical applications European Parliament positive vote on PVC in 2007 European Parliament positive vote on PVC in 2007 Vinyl 2010 is making progress Vinyl 2010 is making progress DEHP under pressure in medical applications – label required DEHP under pressure in medical applications – label required Eco-labelling based on antiquated science Eco-labelling based on antiquated science Positive aspects of PVC in medical devices for the first time on display on medical museum Positive aspects of PVC in medical devices for the first time on display on medical museum