Battelle, renowned for its extensive expertise in research, laboratory analysis, and consulting on Per- and Polyfluoroalkyl Substances (PFAS), is now leveraging its skills in response to the growing awareness and regulation of these chemicals. With increasing federal regulations like the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) and the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), along with state and international PFAS bans, medical device manufacturers are encountering new challenges related to record-keeping, production, and waste management.
“Battelle doesn’t hesitate to tackle complex challenges in any of the industries we serve.”
PFAS, valued for their chemical and heat resistance, durability, lubricity, and biocompatibility, have been crucial in the production of various products, including medical devices. However, their environmental persistence and potential health risks have prompted global regulatory actions impacting the medical device industry.
Over a dozen states have enacted laws affecting product manufacturers and retailers in specific sectors. States like Maine and Minnesota are implementing broad legislation that will apply to “all products” and will take effect between 2024 and 2032.
As regulations evolve, medical device manufacturers may need to reformulate products to reduce or eliminate PFAS without compromising performance or safety. This could lead to increased costs related to compliance, including testing, certification, and potential redesigns. Additionally, there is a growing reputational risk as consumers and healthcare providers become more aware of PFAS issues.
“Battelle can help medical device manufacturers navigate current and evolving regulations and establish themselves as proactive leaders in the industry,” said Shalene Thomas, Battelle’s Emerging Contaminants Program Manager. “Our support includes understanding the regulatory landscape, identifying and addressing PFAS in products and processes, developing alternative materials, ensuring supply chain transparency, engaging with regulators, and communicating effectively with stakeholders.”
Battelle’s team of scientists and researchers has been investigating PFAS for nearly two decades, developing innovative solutions for testing, analysis, and destruction. The organization operates one of the leading PFAS testing facilities in the U.S. and is among the few accredited labs equipped to handle challenging matrices like landfill leachate.
As a pioneer in site assessment and remediation for PFAS, Battelle conducts crucial research on the behavior and transport of PFAS compounds, aiming to effectively remediate contaminated sites and reduce environmental and health risks.
“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 by providing solutions that help maintain business continuity and minimize supply chain disruptions as new regulations are implemented.”
In 2023, Battelle spun off Revive Environmental, which utilizes the PFAS Annihilator® technology to eliminate PFAS in landfill leachate and aqueous film-forming foam (AFFF) at contaminated sites. Additionally, Battelle developed PFAS Signature®, an innovative method for understanding source attribution and tracking the fate and transport of these chemicals, aiding companies in making informed decisions.
About Battelle
Battelle applies science and technology to address the most critical issues of today. Operating major technology centers and national laboratories worldwide, Battelle engages in research and development, product design and manufacturing, and critical services for both government and commercial clients. Founded in 1929 and headquartered in Columbus, Ohio, Battelle serves the national security, health and life sciences, and energy and environmental sectors.
