Battelle Prepares to Guide Medical Device Companies Through New Federal, State and International Regulations on “Forever Chemicals”

Battelle’s longstanding research, laboratory analysis and consulting expertise in Per- and Polyfluoroalkyl Substances (PFAS) are being applied in a new capacity as the pervasiveness of the chemical class becomes better known and more broadly regulated. From federal regulations such as the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) and the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) to state-specific and international existing or developing PFAS bans, medical device manufacturers are now facing mounting record-keeping, recording and reporting requirements regarding supply chain uses, production volumes and waste handling and disposal.

Known for their chemical and heat resistance, durability, lubricity and biocompatibility, PFAS have been integral in manufacturing various products, including medical devices. However, their persistence in the environment and potential health risks have led to sweeping regulatory actions globally that are starting to impact the medical device industry.

More than a dozen states have already passed laws affecting product manufacturers and retailers across specific sectors, while some states, such as Maine and Minnesota, are implementing far-reaching legislation that will consider “all products” and take effect between 2024 and 2032.

As regulations progress, device manufacturers may be challenged with reformulating products to eliminate or reduce PFAS content without sacrificing performance or safety. These companies may be faced with increased costs associated with compliance, encompassing testing, certification and potential redesign of products. Finally, there may be reputational risk as consumers and healthcare providers become more informed and concerned about PFAS.

“Battelle can help medical device manufacturers evaluate current and developing regulations and position themselves as proactive leaders in the market,” said Shalene Thomas, Battelle’s Emerging Contaminants Program Manager. “That includes understanding the regulatory landscape, identifying and addressing PFAS substances in products, facilities and processes, sourcing and developing alternative materials, ensuring supply chain transparency, engaging with regulators to better understand waste and environmental liabilities, and communicating effectively with stakeholders.”

Battelle’s team of experienced scientists and researchers has been studying PFAS for nearly two decades and has developed innovative solutions to advance the testing, analysis and destruction of PFAS.

Battelle operates one of the leading PFAS testing facilities in the country and is one of a limited number of laboratories accredited to test more challenging, non-traditional matrices for PFAS such as landfill leachate.

As a leader at the forefront of site assessment and remediation for this emerging class of chemicals, Battelle conducts critical research to better understand the fate and transport of PFAS compounds and how contaminated sites can best be remediated to minimize and eliminate environmental and human health exposures.

"Battelle doesn't hesitate to tackle complex challenges in any of the industries we serve,” said Mel Sych, Chief Commercial Officer. “Our mission is to support our clients optimally, providing services and solutions that help maintain business continuity and minimize supply chain disruption as new regulations take hold.”

In 2023, Battelle successfully spun off Revive Environmental a company that is deploying the PFAS Annihilator® to destroy PFAS in landfill leachate and aqueous film-forming foam (AFFF) firefighting foams at contaminated sites.

Battelle also has developed PFAS Signature®, an innovative method for understanding source attribution and delineations to determine the fate and transport of these chemicals, as well as source tracking and differentiation of AFFF sources from non-AFFF sources. The insights this tool provides can help companies make better, more informed decisions.

About Battelle

Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.

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