On August 6, 2025, the U.S. Food and Drug Administration (FDA) posted new information concerning the safety of fluoropolymers used in medical devices. Fluoropolymers, which belong to the PFAS class of substances (per- and polyfluoroalkyl substances), have long been used in medical devices, and FDA maintains its position that this use of PFAS is necessary in certain cases and unlikely to cause harm.
Safety of Fluoropolymers in Comparison to Other Types of PFAS
FDA stated that the PFAS used as components in medical devices
are often large-molecule PFAS (polytetrafluoroethylene (PTFE) being
the most well-known example), which differ from other PFAS often
associated with potential environmental and health claims, which
are typically small-molecule PFAS.
Furthermore, FDA cited the findings of a 2021 study conducted by
FDA in a partnership with ECRI, a U.S. Department of Health and
Human Services-designated Patient Safety Organization. The study
reviewed peer-reviewed articles and used real-world clinical and
healthcare surveillance networks and found no evidence of patient
health issues associated with PTFE use in medical devices.
Consequently, FDA has concluded as to PFAS used in medical devices
"that currently there is no reason to restrict their continued
use." Moreover, FDA notes that PFAS is essential to the safe
and effective use of several devices and that no other materials
currently exist that could replace the use of PFAS in these
applications.
Safe Uses of Fluoropolymers in Medical Devices
FDA specifically highlighted the unique properties of fluoropolymers, which serve critical roles in medical devices. For example, fluoropolymers provide:
1. Lubrication for stents and other devices used in minimally invasive surgeries
2. Electronic insulation for pacemaker wires
3. Biostability, which allows devices to remain in the body for long periods of time
Key Takeaways
FDA continues to allow the use of fluoropolymers in medical devices, finding that their use is not associated with patient health issues. As such, FDA is not requiring any action by medical device manufacturers, though the agency continues to monitor the safety of PTFE and other PFAS used in medical devices.
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