Medtech manufacturers are increasingly launching PFAS-free catheters and other medical devices. [Photo by JFontan via Stock.Adobe.com]
The agency cited decades of use and an ECRI review that “found no conclusive evidence of patient health issues associated with PTFE as a material.”
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PFAS are a group of more than 15,000 “forever chemicals” used in a range of industries. PTFE was first used in a medical device in the 1950s. These materials are used in cardiovascular stents, pacemakers, vascular grafts and guidewires. They provide lubrication for devices inserted into the body, electrical insulation for pacemaker wires and biostability for implants that remain in place for long periods.
The FDA statement comes as device manufacturers face growing public and regulatory scrutiny on PFAS use. Some companies are exploring ways to reduce or replace fluoropolymers in coatings and components to address environmental concerns and prepare for potential future restrictions. Industry experts have noted that making such changes will require identifying materials that match fluoropolymers’ performance in safety-critical applications.
3M, a major PFAS manufacturer, pledged to halt all PFAS production by the end of 2025 after paying hundreds of millions of dollars to settle lawsuits over groundwater contamination.
The FDA said the fluoropolymers used in medical devices are chemically different from the small-molecule PFAS linked to environmental and health concerns.
“Fluoropolymers are typically comprised of molecules that are too large to cross through cell membranes and, as a result, are very unlikely to cause toxicity to patients,” the agency said.
The agency said biostability helps prevent degradation of devices in the body, which could otherwise release fragments and lead to serious health risks.
The FDA said there are no alternative materials that can replace fluoropolymers in these devices without compromising performance. Many of the devices involved are critical to saving or sustaining lives.
The FDA’s position follows a safety review it commissioned from ECRI, an independent group designated as a Patient Safety Organization by the U.S. Department of Health and Human Services. The review, completed in 2021, analyzed more than 1,750 peer-reviewed scientific articles and data from 1,800 health care provider organizations.
The FDA said it will continue to monitor fluoropolymer safety and update its position if new information becomes available.
