PFAS and Medical Devices

Per- and polyfluoroalkyl substances (PFAS) are a group of fluorinated compounds characterized by carbon-fluorine bonds. They are synthetic chemicals with widespread use due to unique physical and chemical properties that allow them to provide thermal and chemical stability as well as oil and water repellency.

Known for their chemical and heat resistance, durability, lubricity and biocompatibility, PFAS have been integral in manufacturing a variety of products including medical devices. Their persistence in the environment and potential health risks have led to sweeping regulatory actions starting to impact a variety of sectors, including medical devices.

Considerable epidemiological research has been conducted to understand the possible adverse health effects of PFAS in humans, which can include immunological, developmental or reproductive, hepatic, hormonal, and carcinogenic effects.

There is still progress required by the scientific community to fully understand the exposures to and health effects from PFAS. Closing these gaps in our understanding of these issues is paramount to helping to protect human health.

Most people have some form of PFAS in their blood, particularly PFOS and PFOA. While evidence indicates that exposure to certain PFAS is associated with human health effects, the available information focuses primarily on a small subset of the thousands of chemicals that are part of the chemical class.

Populations are exposed to PFAS through numerous pathways, including ingestion, dermal contact, and inhalation as a result of exposure to food, water, dust, soil, and consumer products.

PFAS are commonly used in a wide range of medical devices because of their biocompatibility, stiffness, long life, chemical resistance, anti-stick properties, low moisture absorption and durability.

A variety of medical devices contain PFAS chemicals, including but not limited to:

• Implanted devices, e.g. pacemakers, cardiac stents and joint replacements
• Orthopedic devices
• Personal Protective Equipment (PPE) including surgical gloves
• Surgical devices
• Healthcare equipment such as catheters, tubing and blood bags

• Patient safety
• Non-adherence
• User adoption and worry

As PFAS chemicals are linked to a variety of human health effects, using a device containing PFAS could impact user safety over time. In addition, the increasing public awareness and concern around PFAS could impact patient adoption or adherence to treatment if they are aware of PFAS presence in their devices.

Historically, regulations targeting PFAS have been focused more broadly on environmental and consumer products, with less specific attention to medical devices. However, as awareness of the potential risk associated with PFAS has grown, regulatory scrutiny has been extended to all industries including medical devices.

For more information on PFAS regulations and medical devices, check out our blog: "The Impact of PFAS Regulations on the Medical Device Industry".

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More than a dozen states currently have regulations addressing PFAS phase-outs and several more with proposed or pending regulations. Phase-out dates depend on the specific state and/or specific sector targeted. Most are targeting between 2024 and 2026 with a few states such as Maine and Minnesota, that have a broad ban of all products by 2032.

The FDA has been primarily focused on PFAS in food entering the food supply via plants and animals grown, raised, or processed in contaminated areas, as well as, food contaminated by PFAS via food packaging, processing, and cookware. In February 2024, the FDA announced that substances containing PFAS were no longer being sold into the U.S. market for use as grease-proofing agents on paper food packaging as a result of a voluntary phase-out program by manufacturers.

At the Federal level, there are many PFAS regulations that may apply to medical devices. In October, 2021, the U.S. Environmental Protection Agency (EPA) published a PFAS Strategic Roadmap that outlined specific actions planned to address PFAS.

New record keeping and recording requirements from the Toxic Substances Control Act (TSCA) now stipulate that manufacturers or importers of PFAS-containing compounds of products submit a report to the EPA regarding uses, production volumes, disposal, and hazards.

Globally, relevant PFAS restrictions and regulations continue to evolve as well. In February 2023, the European Union proposed Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations imposed bans on the family of PFAS, including more than 10,000 specific PFAS in use across a multitude of sectors. Certain PFAS have already been restricted in the EU, some dating back more than 10 years, under the EU’s persistent Organic Pollutants (POPs) Regulation.

Enlisting a trusted PFAS testing partner to confirm presence, types and amount of PFAS in your device can help you determine if your products contain PFAS.

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To find out if your manufacturing process includes PFAS, start by mapping your PFAS footprint from your supply chain and raw materials, through manufacturing, use, and disposal. Ask your suppliers if they use PFAS in their manufacturing processes and if the materials or components they provide contain PFAS.

Our PFAS and medical device experts can help you confidently identify and quantify your organization's PFAS risk, and guide you through next steps, including risk management and PFAS replacement. 

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Your regulatory, quality, compliance or EPA representative should be involved throughout the process of addressing PFAS in medical devices.

Our Battelle medical device and PFAS experts can help you find, develop and formulate effective PFAS alternatives tailored to the applications and needs of the PFAS-contaminated materials.

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Our PFAS experts can help you get started on your PFAS-Free journey, and create key assets like these:

• Regulatory roadmaps
• Risk assessments
• Product inventories

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Battelle has deep experience in PFAS, from conducting human exposure studies in 2007 to the development of sustainable replacements for PFAS.

Our history of addressing PFAS includes:

• 19 years of PFAS research
• 60+ experts in PFAS analysis, assessment, remediation, replacement and more
• 8M+ dollars invested in PFAS technology R&D
• 7 innovative PFAS solutions commercialized
• 600+ different PFAS chemicals in proprietary forensics library

Battelle provides high-quality and comprehensive PFAS testing and analysis services through our nationally accredited PFAS laboratory, located in Norwell, MA.

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We offer a complete suite of PFAS product services ready to take medical device organizations to PFAS-Free, including:

• PFAS product consulting
• PFAS product testing and analysis
• PFAS risk management strategy
• PFAS replacement and alternatives development

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Connect with our PFAS and medical device experts to get answers to your questions around medical devices and PFAS.

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