Device makers' fears about a shortage of raw materials have sharpened since Modern Healthcare first reported their concerns a year ago (June 28, 1993, p. 90).
Chemical giants such as Dow Corning Corp. and E.I. du Pont de Nemours & Co. stopped selling materials used in pacemakers and other common medical implants. Smaller suppliers reportedly have followed suit.
Their reason: Sales aren't worth the risk of lawsuits such as those now plaguing some companies.
The materials giving device makers the most troubles these days are polyester and the tongue-twister polytetrafluoroethylene, the Health Industry Manufacturers Association said. Once made by DuPont, they're used in vascular grafts and other devices.
Small device makers are spending so much money trying to find materials, they've had to cut into their funds for research and development, HIMA said. "I don't think we've seen any actual impact on patients because companies have stockpiled materials," said James Benson, HIMA's senior vice president. "But we now see the potential of affecting patients in a year or two. The trend is away from companies supplying basic materials."
Device makers are pinning hopes for a cure on a proposed amendment to the Product Liability Fairness Act being debated in the U.S. Senate. The amendment would shield materials suppliers from patient lawsuits. HIMA expected it to be introduced late last week by Sen. Joseph Lieberman (D-Conn.).
Consumer groups argue that the government already doesn't regulate the device industry enough and that the threat of lawsuits helps protect consumers from dangerous devices.