PVC and phthalates in medical devices - a historical case study

1. PVC and phthalates in medical devices- a historical case study Ole Grøndahl Hansen PVC Information Council Denmark Plastics in Medical Devices Conference Brussels 9 – 10 April 2008

2. Content • PVC based medical devices – the basics • PVC under pressure in the nineties – a case study of a converter • Study on medical tubing • A European perspective • Health concerns around the change of the century • Alternatives to DEHP in medical devices • Conclusions

3. Use of plastics in the health care sector others 11% PP 13% PS 21% PE29% PVC 29% 85.000 tons of PVC used for medical devices per year in EU Total consumption of PVC in Europe is 7.000.000 tons

4. PVC medical applications The low costs and the high performance of PVC made it possible to manufacture single-use devices in the late 1950’ties. The two main application areas for PVC devices are flexible containers and medical tubing: ie. urine bags, ostomy bags, bloodbags 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.

5. Case study of a subcontractor Company turnover is 7 million € As a subcontractor, Totax Plastic’s 60 employees are manufacturing medical tubing used in hospitals worldwide.

6. 1. ”Incineration of PVC causes heavy dioxin emissions resulting in dioxins in mother’s milk”. 2. ”Incineration of PVC causes acid rain resulting in dead forests”. Danish Minister of Environment in 1990: ”In principle I want to ban PVC.” PVC under heavy pressure In the late 1980’ties, PVC was under heavy pressure in Denmark. The main accusations were: The conditions of existence of the company was threatened because of the PVC-debate. Above Danish newspaper article in 1990.

7. Decisive report from Danish EPA Together with the Danish Technological Institute and the Danish Environmental Protection Agency, Totax Plastic carried out a comprehensive study on medical tubing in 1991.The result was the report: ”Possibilities for PVC substitution in certain medical devices” Report from the Danish Environmental Protection Agency, Copenhagen 1991

8. Requirements for medical tubing First step in the study was to show the requirements to medical tubing. Which are: 1. Flexibility and softness 2. Anti-kink characteristics 3. Strength/memory 4. Transparency 5. Easy to sterilise 6. Surface morphology 7. Ability to link 8. Ease of fabrication 9. Easy to use 10. Cost-effectiveness

9. The study 81 different existing non-PVC types of plastics were tested • In particular none of the tested materials could meet the anti-kink characteristics of the PVC-tubing. • All the tested materials were more expensive than the PVC compound • None of the alternative alternatives were tested for emissions in association with incineration

10. Anti-kink characteristics are essential for PVC medical tubing The non-kinking characteristic is the most important requirement made to materials meant for manufacturing of tubing in medical devices. The chemical structure of PVC is the only one ensuring effective anti-kink characteristics”. Kinking may cause serious complications and life threatening situations for the patient. Kinking means a fold on the tubing, which narrows and stops the passage

11. Overall conclusions of the Danish EPA study from 1991 Technically: PVC is a superior material. All requirements to a medical tubing can only be met at the same time by using PVC Economically: PVC is a superior material. PVC is simply the most cost effective plastic material on the market. Environmentally: In the study the alternative materials were not tested environmentally in any way. The study therefore did not state any conclusions as to whether the environmental performance of the alternatives was better or worse than PVC.

12. Because of the results of the EPA medical tubing study, the continued use of PVC medical tubing was secured in Denmark. For ostomy bags a similar study was carried out, the conclusion of which was that no material could meet the performance of PVC when it came to odour and noise properties.

13. 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 plays no longer 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 secondary 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 of PVC incineration is still of concern to some stakeholders. New knowledge and new technology changed the debate

14. The EU perspective • Initiated by the Danish Environment Commissioner Ritt Bjerregaard, the EU-systems gets involved in the PVC issue in the late 90’ties. • A Horizontal initiative, a Green Paper on PVC and a EU-resolution from the Parliament dominate the PVC debate around the turn of the 21st century. • In 2000 the PVC industry establishes the Voluntary Committment of the whole PVC supply chain called Vinyl 2010. Vinyl 2010 is taking responsible care of emissions, recycling, additives and new waste management technology.

15. EU-Parliament voting • 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

16. New Concerns • Earlier PVC as a material was of concern because of environmental issues. Now the concern is connected to health and consequently the use of additives. The use of phthalates in medical devices is now in focus. • The reason for this shift is partly because of the so called hormone disrupting chemicals. Especially the Danish medical professor Niels Erik Skakkebæk’s hypotesis saying that hormone disrupting chemicals cause detrimental effects in humans is a world wide issue. DEHP is accused of being a hormone disrupting chemical. • For many medical device companies manufacturing DEHP-based devices a search for alternatives to DEHP begins.

17. Study on alternatives to DEHP in 2003 • ”Evaluation of plasticisers for PVC medical devices”. Danish EPA study from 2003. Together with Totax Plastic A/S, Unomedical A/S and Papyrotex A/S. PVC Information Council DK also participated in the study. Conclusions: • Extensive effort is needed before one can decide to substitute any other plasticiser for DEHP • Much more data on the potential alternatives are needed before DEHP can be seriously substituted in medical devices

18. Latest study from EU Commission Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) THE SAFETY OF MEDICAL DEVICES CONTAINING DEHP PLASTICIZED PVC OR OTHER PLASTICIZERS ON NEONATES AND OTHER GROUPS POSSIBLY AT RISK Approved for public consultation by the SCENIHR during the 19th plenary of June2007

19. SCENIHR conclusions (I) • There is limited evidence indicating a relation between DEHP exposures and specific effects in humans. However: New information indicates that there is reason for concern for premature born male neonates. Other population groups at risk are those requiring repeated medical procedures and male infants and male foetuses of pregnant women.

20. SCENIHR conclusions (II) • There are alternative plasticizers to PVC and also non-PVC alternative materials available (The non-PVC alternative materials were not evaluated in the study). For the alternative plasticizers a generic exposure assessment could not be performed, due to lack of data. • Some alternatives may be suitable to replace DEHP in certain medical devices, while for other devices it may be difficult to obtain the same functionalities as PVC plasticised with DEHP • The risk and benefit should be carefully evaluated according to established protocols, for each individual medical device and each medical procedure in which the alternatives are intended to be used.

21. Overall conclusions today • Technically and economically PVC is a superior material for the manufacturing of medical devices. • Because of Vinyl 2010 and because of EU implementation of new incineration technologies PVC should no longer be an issue of environmental concern. • For sensitive medical applications alternatives to DEHP now exist. The benefits of a PVC product can be maintained by choosing among different kinds of plasticisers. • DINCH, Soft ’n Safe, adipate plasticisers, trimellitates and polymerics are good examples.

22. THANK YOU!