PFAS In Medical Devices: A Health Sector Responsibility To Lead

By Shalene Thomas, Senior Emerging Contaminants Program Manager, Battelle

Per- and polyfluoroalkyl substances (PFAS), widely used in medical devices for their durability, biocompatibility, and resistance to temperature and moisture, are under growing scrutiny. Known as “forever chemicals,” PFAS do not easily degrade and have been linked to serious health issues, including cancers and organ damage. While their properties make them ideal for devices like catheters, pacemakers, and surgical implants, mounting regulatory and public pressure is pushing the medical device industry to address their use.

Upcoming legislation and hearings, along with state-level actions, signal an inevitable tightening of PFAS regulations. Complicating this challenge is the fact that viable alternatives to PFAS are limited, and regulatory pathways for modifying medical devices are complex and costly. However, industries outside healthcare, such as outdoor apparel, have successfully transitioned to PFAS-free alternatives without sacrificing performance.

To prepare for this shift, medical device companies can take proactive steps, including conducting material audits to identify non-essential PFAS use, investing in R&D for safe alternatives, and collaborating with stakeholders to share knowledge and promote innovation. Partnerships and transparency—especially with regulatory bodies—are key to navigating the transition effectively.

The industry has an opportunity to lead by example, demonstrating environmental responsibility and commitment to patient safety. Embracing these changes not only helps safeguard public health but also enhances the industry’s reputation. By acting now, medical device manufacturers can pave the way for a safer, more sustainable future—ensuring continued trust and leadership in healthcare innovation.