DOTHAN, Ala. (WDNews) — The U.S. Food and Drug Administration has updated information about PFAS used in certain medical devices, including new answers to common questions from patients.
According to the FDA, the agency updated its PFAS medical device webpage Sept. 1 with a new frequently asked questions section.
PFAS, or per- and polyfluoroalkyl substances, are a group of more than 15,000 chemicals used in a variety of products. The FDA said not all PFAS are the same.
Some smaller-molecule PFAS have been linked to health concerns and have been detected in drinking water and other parts of the environment. However, the FDA said PFAS used in many medical devices are different.
“Fluoropolymers used in medical devices are not the same as the PFAS linked to environmental contamination or health concerns,” according to the FDA. “They differ in chemical structure, molecular size, and how the body reacts to them.”
The FDA said fluoropolymers are large-molecule PFAS used in medical devices because of properties including durability, electrical resistance, biocompatibility and lubricity.
They are found in devices including cardiovascular implants, stents, vascular grafts, catheters, guidewires, tubing and wound dressings.
According to the FDA, the molecules in fluoropolymers used in medical devices are typically too large to cross through cell membranes and are therefore very unlikely to cause toxicity in patients.
“The FDA’s determination based on available scientific studies is that there is no reason to restrict the continued use of fluoropolymers in medical devices,” the agency said.
The FDA reviews and monitors medical devices for safety and effectiveness. The agency considers how a device is used, how long it contacts the body, whether materials could be released and whether its benefits outweigh potential risks.
“The FDA monitors the safety of fluoropolymers in medical devices based on available scientific information,” the agency said. “We will update this page as appropriate to keep the public informed as additional information becomes available.”
