Devices

Medical Device PFAS Appear Safe: FDA

FDA says the per- and polyfluoroalkyl substances (PFAS) used in medical devices are not the same as those identified as being potentially harmful to people in other contexts. An agency online post says the PFAS materials used in medical devices, known as fluoropolymers, have a long history of use. “FDA’s evaluation is that currently there is no reason to restrict their continued use in devices,” the post says.

The agency says that PFAS are a large group of more than 15,000 chemicals that are used in a variety of products, and they are not all the same. “Some PFAS, typically those chemicals composed of small molecules, have been linked to health concerns and have been detected in drinking water and other parts of our environment,” it says.

It explains that currently no other materials exist that can perform the critical roles of fluoropolymers in devices such as cardiovascular stents, pacemakers, vascular grafts, and guidewires. It says the fluoropolymers have unique properties that are essential for devices to function, providing:

lubrication for devices such as the stents used to treat heart problems and delivery systems used in minimally invasive surgical procedures;
electrical insulation in, for example, the wires that lead from a pacemaker to a person’s heart; and
biostability, allowing medical devices to remain in the body for long periods of time without the threat of degradation.

FDA also says that fluoropolymers are typically composed of molecules that are too large to cross through cell membranes and, as a result, are very unlikely to cause toxicity to patients.

The post cites a 2021 safety study conducted by ECRI that found no conclusive evidence of patient health issues associated with polytetrafluoroethylene, the best-known of the materials used in multiple consumer products.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome