Navigating PFAS "Forever Chemicals" In Medical Devices - What's On The Horizon

By Shalene Thomas, Sr. Program Manager, Emerging Chemicals, Battelle

"Forever chemicals" known as per- and poly-fluoroalkyl substances (PFAS) have raised significant concerns due to their persistence in the environment and potential health risks. These man-made compounds are widely used in various industries due to their unique properties, such as thermal and chemical stability, oil and water repellency, and heat resistance. However, their ubiquity in the environment and bioaccumulation have led to increasing regulatory scrutiny.

The medical device industry is particularly impacted by the evolving regulatory landscape for PFAS. Inconsistent regulations and standards, coupled with the lack of alternatives for essential uses, pose significant challenges for manufacturers. Understanding the different classes of PFAS, their unique properties, and the potential health risks associated with them is crucial for navigating the regulatory landscape and ensuring compliance.

Gain an understanding of PFAS, their properties, environmental impact, health risks, and regulatory challenges, focusing on the specific implications for the medical device industry. By understanding the key points and challenges discussed here, manufacturers can better assess the potential impact of PFAS on their operations and take proactive steps to mitigate risks and ensure compliance.