More Than Meets The Eye - PFAs In Medical Devices And The Suppy Chain

Examine the widespread use of per- and polyfluoroalkyl substances (PFOS/PFAS) in medical devices and the growing regulatory, environmental, and supply chain challenges they pose. PFOS are valued for their durability, lubricity, and resistance to heat and chemicals, making them integral in products such as catheters, inhalers, joint replacements, packaging, and coatings. However, their persistence in the environment and potential health risks have earned them the label “forever chemicals,” placing them under increasing global regulatory scrutiny.

Currently, medical devices face limited direct regulation, but environmental policies in the U.S. (CERCLA, TRI) and Europe (REACH) are tightening. Manufacturers may face liability, stricter reporting thresholds, and potential bans or limits on PFOS use. With major suppliers like 3M and BASF exiting PFAS production, sourcing challenges and rising costs add further supply chain pressure.

The webinar emphasized the importance of process mapping, supplier collaboration, and testing strategies to identify both intentional and unintentional PFOS sources. Methods such as combustion ion chromatography can screen for fluorine, while advanced mass spectrometry may be needed for specific identification. Manufacturers must be proactive, as exemptions may require device-by-device justification, and replacement materials demand extensive safety and performance testing.