Medical Device PFAS: Managing Compliance And Risks In Manufacturing

By Leonard Harris, Senior Scientific Advisor, Eurofins Medical Device Services

Navigating the evolving landscape of global regulations concerning Per- and Polyfluoroalkyl Substances (PFAS) in medical devices requires a proactive, comprehensive strategy. Manufacturers must prioritize understanding the presence of PFAS within their devices through thorough process mapping and supply chain scrutiny to mitigate regulatory and patient risks. While the intentional use of fluoropolymers like PTFE and FEP is common due to their stability, unintentional contamination from sources like municipal water, packaging, and lubricants presents significant challenges.

The transition away from PFAS, driven by legal pressures and tightening regulations, is a complex and prolonged process requiring extensive testing and validation, including extractables and leachables, toxicological risk assessments, and material compatibility studies. Because a lack of comprehensive test methods and the vast number of potential compounds complicate measurement, a combination of advanced analytical techniques, such as Combustion Ion Chromatography (CIC) and LC-TOF-MS, is essential for accurate identification and compliance. To ensure device viability and safety, manufacturers must prepare for the detailed process of identifying and testing safe replacements.

Download the full article to learn more about managing these critical compliance and manufacturing risks.