WASHINGTON (Legal Newsline) – Any legislation designating an entire family of chemicals as hazardous and toxic could deter medical device makers from producing life-saving devices, manufacturers are warning.
Medical devices made from flouropolymers, a compound of per- and polyfluoroalkyl substances (PFAS), have been in use for more than 50 years without any adverse effects on patients, said Scott Whitaker, president and chief executive officer of the Advanced Medical Technology Association (AMTA), wrote in a letter to the U.S. House of Representative's Armed Services Committee.
The devices are "thoroughly assessed" by the Food and Drug Administration (FDA) before they are allowed on the market, Whitaker wrote in the letter, adding that his organization objects to including all PFAS, including those found to be completely safe, in any legislation.
An amendment to the National Defense Authorization Act (NDAA) that included the designation was in a House version passed in July. The Senate amendment will authorize much stricter monitoring and other measures. The NDAA is currently in conference.
A number of House Democrats, most notably Rep. Debbie Dingell (D-Michigan), are in support that PFAS chemicals to be named as hazardous under the Comprehensive Environmental Response Compensation and Liability Act (CERCLA).
If designated under the act, site owners are liable for cleanup costs, as are those that brought the chemicals to a facility. But they will also be listed as toxic pollutants under the Clean Air Act and as waste under the Resource Conservation and Recovery Act.
"Circumventing the existing regulatory process for determining hazardous substances and waste could threaten the ability of our members to continue to provide patients with life-saving devices," Whitaker wrote.
Further, describing fluoropolymers as hazardous or toxic would signal to patients and health care providers that their use is not safe, Whitaker said, adding this is despite decades of clinical trials.
Medical device manufacturers want the EPA to have authority to assess and decide which members of the PFAS family should be designated under the various statutes.
PFAS chemicals, of which there are hundreds, have been widely used in products since the 1950s. Apart from firefighting foam, this includes food packaging, nonstick cookware, outdoor gear, and medical applications. They persist in the environment and have been linked to harm to humans, including cancer, kidney disease and birth and developmental disorders
Two in the family have raised particular concerns, perfluorooctane sulfonate (PFOS) and perfluorooctanic acid (PFOA).