Article | January 15, 2025

Q&A: Navigating PFAS In Medical Devices

Source: Battelle
Wooden blocks PFAS-GettyImages-2145498657

The growing presence of per- and poly-fluoroalkyl substances (PFAS), also known as "forever chemicals," in medical devices raises significant environmental and health concerns. PFAS are valued for their durability, thermal stability, and biocompatibility, making them integral to products like catheters, stents, and personal protective equipment. However, their persistence in the environment and links to health risks, including immunological, developmental, and carcinogenic effects, have drawn regulatory scrutiny.

PFAS enter the environment through chemical production, consumer product use, and disposal, contaminating air, water, and soil. Human exposure occurs via ingestion, inhalation, and dermal contact, with drinking water as the primary source. Most people have detectable PFAS levels in their blood, with compounds like PFOA and PFOS under particular investigation.

Evolving federal and state regulations, such as the EPA’s PFAS Strategic Roadmap, are driving changes. The medical device industry faces challenges including redesigning products, sourcing PFAS-free materials, addressing supply chain disruptions, and managing waste. As public awareness grows, manufacturers must balance innovation, compliance, and patient safety.

Battelle offers expertise to navigate these challenges, providing alternative formulations, chemical analyses, and health exposure studies. Their solutions encompass regulatory reviews, risk assessments, and environmental remediation. With two decades of experience, Battelle equips the medical device industry with scalable strategies to address PFAS concerns, ensuring compliance and sustainability while minimizing impact on patient care.

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