PVC has been a solid performer in disposable medical products because it's relatively inexpensive, easily manufactured, and works well. But questions are cropping up as to whether or not it harbors long-term negative effects. Enough questions have surrounded the plasticizers in the material (plasticizers make polymers more flexible) and PVC itself to prompt some buyers, such as medical contract manufacturers, to inquire about replacements. The source of the suspicion has been an 18-page list of carcinogenic and potentially carcinogenic materials in California's Proposition 65 (oehha.ca.gov/prop65).

The proposition has prompted buyers to at least ask about replacements for the material. “Inquiries regarding replacement plasticizers and PVC-free materials have come from medical-device makers along with manufacturers for beverage, tubing, and potable-water containers,” says Thomas Moore, spokesman for Raumedic Inc., Leesburg, Va. (raumedic.com). The company compounds polymers and extrudes, molds, and fabricates materials for the medical industry. Moore says the company developed alternatives to a plasticizer called Di(2-ethlhexyl) phthalate or DEHP over 25 years ago to accommodate specific markets. The requests for nonDEHP PVC now come from numerous markets. The firm says it has prepared itself for this market shift by increasing its DEHP-free PVC portfolio and by developing a nonPVC alternative. The company still sells DEHP PVCs into European, Asian, and American markets. “The drawback to eliminating DEHP is that it has a long and well known track record in the medical industry, and a replacement, less so.”

While the nonDEHP material works well, cost targets have been harder to hit. The new material is considered a premium or non-commodity product. However, the price gap in the U.S. between nonDEHP and DEHP materials has been narrowing. Although contract manufacturers today are more sensitive to the presence of any PVC in a product or part, they are only buying PVC-free tubing in small quantities. Moore says manufacturers want a new material to have the same attributes as PVC, meaning cheap, flexible, and easily fabricated.

“But you only take quality so far with commodity material. Companies are going green - beginning to develop long-term strategies to service their markets with completely non-PVC infusion or disposable products. However, such products that are as versatile as PVC and cost the same are a holy grail,” says Moore.

Early material tests on these potential replacements have been successful. “Their performance in terms of bonding quality, kink resistance, and pump performance will satisfy most customers. Although every customer has different benchmarks to hit, feedback has been positive. Some large OEM customers have already successfully launched nonPVC systems,” he adds. The drawback is that it costs more, about twice that of PVC, so it's not a commodity material. Moore suggests that device manufacturers might be able to promote the PVC-free products and recoup their cost premium, but that remains to be seen.