PVC Defections Continue

Despite reassurances from a large segment of the scientific community that the potential health and safety hazards of PVC are vastly overstated, the material's privileged position within the medical device industry continues to erode.

Tenet Healthcare Corp., the nation's second-largest healthcare provider, recently announced that it would develop a purchasing policy favoring the use of PVC-free and phthalate-free disposables in its hospitals. Equally momentous was the decision of Baxter International to sign a memorandum with a group of shareholders underscoring its commitment to "explore and develop alternatives to PVC products." It should be noted that Baxter has stressed that its move away from PVC had "nothing to do with the unwarranted concern raised by activist groups regarding the safety of PVC." That clarification did not prevent the signing from becoming a watershed event for many in industry, however.

"Baxter's decision was a milestone," says Hermann Koch, product manager at Germany-based Sengewald Verpackungen, a supplier of coextruded polypropylene film that can be used as an alternative to PVC in medical fluid bags. "It had a big influence on other companies to think very seriously about the PVC issue," explains Koch.

Economical and easy to fabricate and sterilize, PVC remains the most widely used polymer in presterilized single-use medical applications. To make PVC flexible, plasticizers such as DEHP are added. When lipid-containing fluids like blood are stored in PVC containers, these plasticizers can migrate into the body in the fluid. Some groups, such as Health Care Without Harm, have claimed that such exposure to plasticizers is toxic.

PVC remains the polymer of choice for a range of medical devices, but health and ecological concerns are prompting some firms to seek alternative materials.

Last year, these concerns led the European Commission to ban soft PVC containing phthalates from toys that would be put in babies' mouths. The commission is currently conducting a horizontal cradle-to-grave life cycle study of PVC in nonmedical applications. Results are expected to be released by the end of this year.

"Lessons learned on additives in soft PVC toys need to be applied to medical devices," says Joe Di Gangi, PhD, author of a Greenpeace report on the alleged dangers of plasticizers. "Why expose a vulnerable population such as patients to toxic chemicals when alternatives are readily available?"

The plastics industry counters that there are no studies proving that plasticizers can be harmful, and that cost-effective and safe alternatives to PVC simply do not exist. Last year their position was given a boost when a panel convened by the American Council on Science and Health and led by former surgeon general C. Everett Koop, MD, concluded that plasticizers are harmless even to people who have been exposed to high levels. "The burden of responsibility will weigh heavily on whatever group or individual advocates eliminating DEHP products without a safe, proven alternative," the report stated.

In an interview with MPMN, Robert Brookman, vice president of Teknor Apex, which supplies PVC, predicted that there won't be any wide-scale deselection of PVC in the U.S. medical market because few good alternatives to PVC exist. "It's either a cost issue or a performance issue, and often it's both," said Brookman. "PVC is really quite unique. Its clarity, flexibility, and ease of fabrication can't be matched by the alternatives, and most of them cost more anyway.

"The problem is that we are dealing not with medical science but with emotionalism," added Brookman. "We scientists see all this as a nonissue." Advocates of a ban on plasticizers obviously disagree, and they are not likely to cease their protest in the foreseeable future. —Karim Marouf

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