Turning PFAS Challenges Into Opportunities

The medical device industry is under increasing pressure to address environmental and health concerns linked to per- and polyfluoroalkyl substances (PFAS). These “forever chemicals” are widely used in medical products for their durability and chemical resistance. However, global regulatory bodies, especially in Europe and several U.S. states, are tightening restrictions on PFAS. While medical devices were once considered “essential use” and exempt from some regulations, that designation is now under review, particularly for single-use and disposable products.

Europe’s REACH regulation and similar U.S. state laws (e.g., in California and Maine) are driving this shift. Manufacturers may soon need to prove that PFAS use in each product is truly essential and irreplaceable—prompting a push for safer alternatives and more sustainable design practices.

Circularity has emerged as a powerful strategy to mitigate PFAS risks and build supply chain resilience. During the COVID-19 pandemic, Battelle demonstrated rapid innovation by developing a decontamination system for N95 masks—showing that circular solutions can be deployed at scale. Reusable, recyclable, and resource-efficient products not only reduce PFAS dependency but also lower long-term costs and waste.

To future-proof operations, companies should monitor evolving regulations, evaluate PFAS use in products, invest in circular design, and collaborate across the supply chain. Partnerships, like those with Battelle, can help accelerate innovation and adoption of sustainable alternatives.

Ultimately, addressing the PFAS challenge is more than regulatory compliance—it’s a strategic opportunity to lead in sustainability, protect human health, and strengthen market position.