Battelle Helps Medtech OEMs Navigate PFAS Regulations

International, national, and state regulations targeting the presence of per- and polyfluoroalkyl substances (PFAS), commonly referred to as “forever chemicals,” pose a major challenge for medical device manufacturers. Existing and developing PFAS bans require extensive record keeping and reporting on supply chains, production volumes, and waste handling and disposal, according to global R&D company Battelle. The storied nonprofit, which was founded in 1929, says it can help medical device manufacturers navigate this rocky, evolving regulatory terrain.

Sweeping regulations impact medical device industry

Known for their chemical and heat resistance, durability, lubricity, and biocompatibility, PFAS have been integral in manufacturing various products, including medical devices, writes Battelle in a news release. 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. Some states, such as Maine and Minnesota, are implementing far-reaching legislation that will consider “all products” and take effect between 2024 and 2032, notes the Columbus, OH–based nonprofit.

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Reformulation of products a particular challenge

A specific challenge facing medical device manufacturers involves the reformulation of products to eliminate or reduce PFAS content without sacrificing performance or safety. This can be time-consuming and costly in a heavily regulated industry. Battelle’s researchers have nearly two decades of experience studying PFAS and have developed innovative solutions to advance the testing, analysis, and destruction of those chemicals. The company is making that expertise available to the medical technology industry.

“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.”

PFAS testing expertise

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.

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, said Battelle.