Devices

FDA Backs PFAS Used in Medical Devices

FDA has added a new frequently asked questions section to its Web page on PFAS (per- and polyfluoroalkyl substances) in medical devices, saying it has found no evidence that certain PFAS materials widely used in medical equipment are harming patients.

The agency said its review of scientific literature and post-market safety information supports continued use of fluoropolymers, large-molecule plastics that are part of the broad PFAS chemical family.

"The FDA is not aware of any evidence" that fluoropolymer PFAS materials used in medical devices have harmful public-health effects, the agency said, adding that in there was no reason to restrict their use.

The agency’s position distinguishes fluoropolymers used in medical devices from other PFAS chemicals, particularly smaller molecules that have been linked to health concerns and found in drinking water and the environment.

FDA said fluoropolymers have been used in medical devices since the 1950s and are now found in thousands of products, including catheters, cardiovascular implants, tubing, wound dressings and components of pacemakers. It has monitored the materials through its post-market medical-device safety program and has not identified toxicity problems associated with their use.

The agency also commissioned ECRI, an independent health care research organization, to examine the safety of polytetrafluoroethylene, or PTFE, the most widely used PFAS material in medical devices.

ECRI reviewed more than 1,750 published, peer-reviewed scientific articles and collected information from more than 1,800 health care provider organizations, according to FDA. Its 2021 review found no conclusive evidence of patient health problems associated with PTFE, the agency said.

The agency said it will continue monitoring scientific and safety information on fluoropolymers.

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