Medical Device Manufacturers: Know Your PFAS Risks

Regulations around per- and polyfluoroalkyl (PFAS) substances—so-called “forever” chemicals—are growing worldwide, including at the U.S. state level. But the risks to medical device manufacturers that use them in their products go far beyond regulatory compliance.

The Challenge of Discovering PFAS in Your Supply Chain

Assent has collected data on millions of parts and identified more than 700 unique PFAS chemicals in use. Although that’s less than the EPA-defined 16,000+ PFAS, which includes thousands of theoretical or laboratory-only chemicals, it’s still an overwhelming number of substances and associated data to keep track of. Determining where PFAS exist and complying with reporting obligations takes much more work than simply asking your suppliers a “yes/no” question.

The applications of PFAS are endless, thanks to the various properties PFAS can impart to materials. This adds to the complexity of identification. For most, if not all, manufacturers, there is no way to verify that they have zero PFAS usage in their facilities or portfolios. They have been used for so many purposes for so many decades that a company that doesn’t identify PFAS either hasn’t been looking long enough or is an exception indeed.

Nearly every manufacturer working with Assent that has begun PFAS data collection has identified these substances in their supply chains. We’ve collected data on over six million parts on behalf of our customers at this point, so there is a lot of information we can now draw from to help them identify their risk. The most common PFAS being reported is polytetrafluoroethylene (PTFE), a fluoropolymer best known by the brand name Teflon, followed by 1,1-Difluoretylen-hexafluorpropenpolymer (PVDF-HFP).

While there are ongoing discussions with regulators about the inclusion of fluoropolymers such as PTFE and PVDF-HFP in restrictions, they are currently in scope of most regulations. Whether or not they’re included in future restrictions could have a big impact on industry’s abilities to maintain current designs and processes.

For Assent customers, an average of 3% of their purchased components are reported as having PFAS. For most manufacturers, this rolls up to over 90% of their finished goods containing PFAS. For example, think about the use of PFAS in an O-ring, plastic molded part, or wire coating. Nearly every finished product from that manufacturer may contain one or more of these parts, and therefore every finished product will contain PFAS. As more jurisdictions require reporting of any products that contain PFAS, this could pose a tremendous data and documentation burden on manufacturers as they prepare the majority of their portfolio for submission.

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PFAS Risks to Medical Device Manufacturers

Medical devices, while often excluded from restrictions, are seldom excluded from reporting obligations. This exposes them to risk, as many medical device manufacturers don’t know if PFAS are in their products or factories. If you don’t know where the PFAS are located—both in your materials and the processes you and your suppliers are using, such as electroplating—you can’t understand what your real risk is.

One of the most significant risks they face is obsolescence, which could force product or process redesign. Rising regulatory pressures, mounting lawsuits, and growing consumer concerns have caused some PFAS manufacturers to stop production of certain goods. 3M, for example, ended PFAS manufacturing in 2025, which resulted in the discontinuation of 25,000 products that contained PFAS. This action affected thousands of companies across many tiers of the supply chain.

As suppliers phase PFAS out of the supply chain, manufacturers may struggle to find the parts they need to create their products or run their processes. PFAS-reliant materials could become more scarce, prices could rise, and businesses reliant on a single supplier for critical parts could face disruptions.

Products may need to be redesigned if a PFAS-reliant part cannot be procured or if there’s no longer market demand for the product. That’s why it’s important to know which PFAS are being used—the risks, both regulatory and obsolescence-related, are much higher with some substances, like PFOA, than with others, like PTFE. Redesigning a product is an expensive, costly process and recertification may be required before national authorities allow it to be sold in their markets, which also adds time and cost.

We’ve already seen 3M discontinue their PFAS business, while other major PFAS manufacturers such as BASF and Ecolab have similarly announced that they’re getting out of the PFAS business. The availability of PFAS is decreasing as the price of the remaining materials is increasing. This will pose challenges to the industry in the long term, and redesign may be forced by obsolescence instead of regulation.

Another risk is liability. For example, in June 2023 and August 2025, 3M and DuPont finalized their respective multi-billion-dollar settlements addressing PFAS contamination in U.S. drinking water sources. And more than 100,000 PFAS-related lawsuits have been filed in the U.S. since 2020 alone. While these lawsuits targeted chemical manufacturers, the trend has shifted as lawsuits increasingly target companies that use PFAS in their processes, products, or both. Several states are now suing businesses that use PFAS in their final products or processes to hold them accountable for environmental contamination. Class-action lawsuits are also starting to emerge against companies that use PFAS in consumer products.

Many regulations restricting the use of PFAS in products include exemptions for medical devices with U.S. Food and Drug Administration (FDA) oversight. This will keep market access for those manufacturers mostly open. But while the legal risk may be slightly lower than companies in other industries, the impact of parts obsolescence may be greater due to the critical nature of their equipment and complex certifications.

Even manufacturers that successfully lobbied for exemptions don’t have carte blanche to continue using PFAS at will with no obligations.

For example, while the FDA has said there’s no reason to restrict PFAS-based materials in medical devices, many states still include medical devices in their reporting requirements. That means medical device manufacturers still need to know which PFAS are used, where, and how much.

The biggest risk of PFAS use to medical device manufacturers isn’t from regulation itself, but rather from supply chain obsolescence.

As chemical companies continue to face massive tort litigation and settle lawsuits, their incentive to continue manufacturing PFAS diminishes—as does demand for these chemicals, since other industries don’t necessarily receive the same restriction exemptions as medical devices.

Mitigating PFAS Risk

Medical device manufacturers that proactively look for PFAS in their supply chains understand the common uses of PFAS in their products and have access to reliable, updated supply chain data. Beyond being prepared for extensive new PFAS reporting requirements ahead of deadlines, they will also reduce their risks from PFAS liabilities, potential lawsuits, and parts obsolescence.

Manufacturers shouldn’t wait until they are negatively impacted by a law. And it would be a mistake to assume they are out of scope of every regulation—because they’re not. They should understand now where they’re using PFAS and evaluate the applications to determine their short- and long-term risks of both a restriction for the application as well as the risk of obsolescence of critical parts and materials.

Centralized supply chain data management helps manufacturers mitigate these risks. In 2025, for example, Canada required PFAS reporting of 312 substances (including PTFE) that had been manufactured or imported to Canada in 2023. Assent customers who had already collected data from their supply chain and identified where these specific PFAS were being used were able to complete their registration obligations quickly.

This was a good first effort, but 2026 will bring even more comprehensive reporting, including in the state of Minnesota for current portfolios. Data collected from suppliers is the foundation for a PFAS risk management strategy, so manufacturers will want to start engaging with their suppliers and assessing their own processes for PFAS as soon as possible.

Cally Edgren has over 30 years of experience working at global manufacturers, including Rockwell Automation, Kohler Co., and Rayovac. She now leads a team of regulatory experts at Assent, a supply-chain sustainability software provider, as the Vice President of Regulatory & Sustainability. She’s known for her expertise in product materials regulations, market access certifications, and supply chain sustainability initiatives. In recent years, she’s been recognized as an industry-leading expert on PFAS regulations and has appeared on Bloomberg, FINTECH, and Scripps, among other prominent media outlets, to discuss the various issues affecting complex manufacturers. Cally graduated from the University of Wisconsin with degrees in industrial engineering and enjoys developing programs, systems, and processes to create and qualify safe, compliant products. She’s passionate about product compliance and helping manufacturers build strong partnerships with their suppliers to support their market requirements.