Statement by Eucomed

The European Association of Medical Device Manufacturers

EUCOMED Position on the Use of Plasticised PVC in Medical Products

The medical industry's role is to provide critical therapies for life-threatening diseases. The industry's primary responsibility is to the patient, and there is total commitment to manufacture only therapeutically effective products in which the risks to patients are minimized and to use the most appropriate materials in doing so.

Medical products containing plasticised PVC were developed as replacements for natural rubber and glass. Products made from this material were easier to sterilise, more transparent, flexible, physically reliable, chemically stable and cost-effective. In addition, plasticised PVC often has important functional attributes such as improving the storage of red blood cells.

PVC used in medical products is often plasticised by using DEHP, di-(2-ethylhexyl) phthalate. DEHP has been accused of presenting a carcinogenic risk to humans. However, based on all existing scientific data today, there is no known cancer risk to humans at typical exposure levels, a view recently endorsed by the WHO's International Association for Research in Cancer. Moreover, DEHP is the only plasticiser recommended by the European Pharmacopoeia ("quality specifications for pharmaceutical preparations and their ingredients") for use in pharmaceutical and medical products.

EUCOMED fully agrees with the American Council on Science and Health when it highlighted in the 1999 Koop Report: "It is important for the medical community and the public to understand that removing the phthalate would actually pose a significant health risk to individuals who depend on these devices."

EUCOMED is closely following the work being done in the EU on the risk assessment of phthalates and will, of course, take account in the most appropriate way of any recommendations made by the Commission as a result. The medical industry is continuously evaluating new materials and, indeed, already has a number of non-PVC alternatives. If the overall performance and safety of an alternative material were proven to be superior to plasticised PVC, and assuming regulatory clearance is obtained, such alternatives would be used where appropriate. However, for a number of applications no real alternative material with respect to performance and safety has so far been found.

EUCOMED's view is that phthalate-plasticised PVC has a long history of safe and effective use in medical products and where alternatives are being proposed these often have no such history of safe use. It is estimated that there have been more than 6 billion patient days of exposure to medical products containing plasticised PVC in over 40 years without any reports of adverse effects. Therefore, the many benefits of the continued use of plasticised PVC in medical products totally offset any perceived risks.

Concerning the recent decision by the EU to classify DEHP as a category 2 reproductive toxicant, EUCOMED would like to reaffirm that it continues to support the use of DEHP. Classification and labeling of substances is done to indicate the hazard properties of a substance and not the risk posed by normal or even extreme use. Therefore, this decision by the EU does not change EUCOMED's stated position on the appropriateness of using DEHP to plastify PVC medical products