The U.S. Food and Drug Administration (FDA) has released data that it says affirms the safety of certain per- and polyfluoroalkyl substances (PFAS) used in medical devices.
In a recent update to its webpage “PFAS in Medical Devices,” the FDA reports the findings of a 2021 review of the safety of fluoropolymers used in medical devices, conducted in partnership with ECRI, a Department of Health and Human Services-designated Patient Safety Organization. The joint study reportedly collected data from over 1800 health care provider organizations around the country and also reviewed over 1750 published and peer-reviewed scientific articles.
According to the FDA, the review found “no conclusive evidence of patient health issues” in connection with the use of the PFAS polytetrafluoroethylene (PFTE) as a material.
In further support of its findings, the FDA notes that many fluoropolymers are comprised of molecules that are too large to cross through cell membranes and…”are very unlikely to cause toxicity to patients.” Further, the agency says fluoropolymers have “unique properties” that are essential to device functionality, and that “no other materials (currently) exist that can perform the critical roles of fluoropolymers in these devices.”
The FDA’s updated webpage on the use of PFAS in medical devices is available at https://www.fda.gov/medical-devices/products-and-medical-procedures/pfas-medical-devices?utm_medium=email&utm_source=govdelivery.
