Navigating PFAS: Preparing for medical device regulatory hurdles

Leonard Harris, Senior Scientific Advisor, Eurofins Medical Device Services

The bioaccumulation of PFAS compounds within the body is linked with a wide array of health issues. These “forever” compounds are widely used in the medical device industry due to their durability, heat resistance, and lubricity; but with a dizzying 15,000+ compounds, the health and environmental impacts of use are largely unknown. Known as forever chemicals, these accumulate over time and are of concern as recent studies link PFAS with a gamut of serious health issues, so their toxicological effects must be studied and characterized to ensure long-term patient safety. As such, government and regulatory agencies are enacting measures to limit or ban the use of these compounds, leaving many manufacturers wondering how to mitigate imminent PFAS regulations and the impact these will have on their medical devices and raw materials suppliers.

Eurofins Medical Device Services North America is pioneering PFAS testing in the medical device industry with GMP PFAS testing and PFAS Risk Assessments in 2025. Using a combustion ion chromatography system at the Lancaster, PA, campus, the process screens for the presence of PFAS in medical devices, both intentional and unintentional, from concept and supply chain to final finished product. This testing quantitates compounds through screening for the fluoride ion within a GMP quality system to ensure data withstands regulatory scrutiny.

Leading medical device manufacturers are preparing for regulations, developing mitigation strategies for the future in terms of fiscal liability regarding the effects of these compounds, the environment, and the population. Implementing PFAS testing early in device development will allow device manufacturers to get ahead of regulations and avoid future shutdowns, recalls, and liability concerns, while supporting sustainability goals..