Since the 1940s, per- and poly-fluoroalkyl substances (PFAS) have been used in a wide variety of products and manufacturing processes. This class of more than 12,000 artificial chemicals is found in non-stick cookware, cosmetics, firefighting foam, and many other everyday items. PFAS is also prevalent in medical devices, where its distinct characteristics, including heat and chemical resistance, low friction, durability, and flexibility, significantly enhance device performance. 

However, PFAS have been criticized for their potential impact on health and the environment. These chemicals boast strong carbon-fluorine bonds, making them extremely useful for many applications but also highly persistent, lingering in the environment or the human body longer than most. Due to this characteristic, they’ve more recently been labeled “forever chemicals.” 

Governments have slowly gained increased awareness about the potential long-term effects of the widespread use of PFAS, and worldwide efforts to remove these chemicals from medical device manufacturing are gathering momentum. 

The imminent introduction of PFAS regulations presents an urgent and complex challenge for medical device manufacturers: how to adhere to PFAS restrictions while maintaining the performance and efficacy of life-saving technology. 

PFAS Use in Medical Devices 

PFAS can be separated into two main types: polymeric and non-polymeric. Polymeric PFAS are less mobile in the environment, so they are not as likely to be harmful. They contain large molecules made of repeating units and are primarily found in industrial applications, including medical devices. Non-polymeric PFAS contain smaller individual molecules and are more harmful to humans. They are also used in medical devices, although not as often. Some examples of PFAS commonly found in medical devices follow.

Polymeric PFAS

Polytetrafluoroethylene (PTFE): This is one of the best-known categories of PFAS. It’s used in medical devices, including catheters and graft materials. PTFE coverings and coatings make devices more biocompatible and reduce microbial contamination, inflammation, and tissue damage. 

Fluorinated ethylene propylene (FEP): FEP offers non-stick properties similar to FTPE and is used in tubing and liners. 

Perfluoroalkoxy alkanes (PFA): PFA are used in medical applications requiring high chemical and heat resistance. They are found in tubing, fittings, and components that require aggressive cleaning and sterilization.

Non-Polymeric PFAS 

Perfluorooctanoic acid (PFOA): Historically, PFOA was used to manufacture fluoropolymers that could be applied to medical device surfaces. However, PFOA use in most applications was phased out in 2015.

Perfluorooctanesulfonic acid (PFOS): Before it was phased out in 2002, PFOS was predominantly used in fluoropolymers and coatings. 

Impending EU PFAS Regulation 

The European Union was the first major government to introduce PFAS restrictions and has taken the most active approach to limiting their use.

In 2009, the EU introduced the Persistent Organic Pollutants (POPs) regulations, limiting the use of PFAS called PFOS in substances and articles. In 2019, the EU added the first PFAS group to the candidate list of Substances of Very High Concern (SVHC) in its Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulations. 

Four years later, in 2023, Denmark, Germany, Norway, Sweden, and the Netherlands proposed fresh REACH regulations, which could ban more than 10,000 specific categories of PFAS used in various industries. The EU PFAS Restriction Proposal claimed that traditional hazard and risk assessment-based strategies cannot be applied because the required data on harmful properties for most PFAS substances is unavailable and not expected to emerge soon. 

The proposal outlined three essential claims: 

• PFAS substances have non-negligible potential to harm the environment and human health; 
• The ECHA has identified the need to follow the precautionary principle; 
• Most PFAS chemicals should be considered one chemical group to prevent substituting restricted PFAS substances with others with similar concerns. 

The proposal initially estimated restrictions would be introduced from 2026 to 2027, but it is now not expected to be implemented earlier than 2029 or 2030. 

The last update on REACH was posted in November 2024, stating that opinion development work will continue. The Committee for Risk Assessment will provide its opinion first, followed by a draft opinion from the Committee for Socio-Economic Analysis. Another consultation will be held after those opinions are released. Restriction options include a complete ban or a ban with time-limited derogations. The latest update suggested alternatives were negotiable. “An alternative option could allow the continued manufacture/use of PFAS instead of a ban, in particular for uses and sectors where […] a ban could lead to disproportionate socio-economic impacts,” the update stated. Medical devices were cited as an example. 

Current regulatory restrictions in the EU are sparse. Toxicity data is only available for a handful of PFAS substances, mostly legacy chemicals such as PFOA and PFOS. Only 14 substances or groups have been added to the SVHC dossier. Of the 357 PFAS substances self-classified under the Classification, Labelling and Packaging (CLP) regulation for one or more human health endpoints considered of most concern, harmonized classification is available for only 41 PFAS. 

Only six PFAS (PFOA, PFOS, APFO, PFDA, PFNA, and PFHpA) have received harmonized classification as “Repr. 1B” according to CLP, putting them in the scope of Carcinogenic, Mutagenic, or Reprotoxic restriction under GSPR 10.4 of MDR. 

U.S. PFAS Medical Device Rule 

Regulation is being developed at the state and federal levels in the United States but changes in the administration could alter future proposals.

To date, U.S. regulators have not issued any specific guidelines concerning PFAS use in medical devices but regulators require all device materials to meet stringent safety and effectiveness standards. Manufacturers must ensure that any components containing PFAS do not pose risks to patients or compromise product performance. 

U.S. regulators recently designated PFOA and PFOS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act, which suggested a move towards stricter regulation. 

Other Countries’ Regulations 

The U.K.’s Health and Safety Executive is developing requirements to restrict PFAS use and is considering banning a selected group of them. However, it is unclear how this might affect medical devices. 

The International Organization for Standardization (ISO) has not issued standards aimed exclusively at PFAS but several existing standards focus on the biocompatibility and safety of medical device materials. One group of standards is the ISO 10993 family, which outlines medical device biocompatibility and biological evaluation methods. These standards would encompass assessments of any PFAS-containing materials. 

It is worth noting that regulators worldwide—including Canada, Australia, and the Nordic countries—have already proposed or implemented PFAS restrictions, ranging from specific bans on packaging materials to wide-ranging assessments of PFAS use and its environmental impact. 

Potential Impact 

Increased regulation may significantly impact medical device manufacturing. European manufacturers will likely be affected first. EU regulation is potentially the most wide-ranging, and the industry has already expressed concerns about 2003’s REACH PFAS proposal. “The current PFAS Restriction proposal would result in significant impacts on the quality and availability of treatments for patients in the EU. Due to the unavailability of suitable alternatives to PFAS, some products would have to be removed from the market,” a MedTech Europe position paper stated. 

Ideally, medical devices would be exempted from restrictions, but that could significantly affect manufacturers. Regardless of the new rules, the world’s largest suppliers have self-regulated the manufacturing of PFAS substances and have agreed to stop producing the compounds by year’s end. Consequently, these chemicals could become scarce and cause supply issues for medical device manufacturers. Any changes in design forced by this scarcity would be subjected to conformity reassessment. 

A Final Word on PFAS Regulation

While it may be moving slowly, PFAS restrictions appear inevitable. Medical device manufacturers should begin preparing for a PFAS-free future to avoid mass disruption. Manufacturers can mitigate the effects by establishing a worst-case scenario, investing in innovation, and engaging a trusted lab testing partner early if they anticipate material changes in existing products. 

Companies waiting on regulators to make the final decisions may find their operations hindered by supply chain issues. Now is the time to act. By working with lab partners and academia, manufacturers can be fully prepared for any regulation, restriction, or outright PFAS ban in the future.

MORE FROM NAMSA: Preparing for the PFAS-Free Era: Urgency and Opportunity for Medical Device Manufacturers

Sandi Schaible joined NAMSA in March 2025 after the acquisition of WuXi AppTec’s U.S. Medical Device Testing operations. She had been with WuXi AppTec since 2011 and now oversees NAMSA’s Analytical Chemistry and Regulatory Toxicology department in St. Paul, Minn. With more than 30 years of experience, Schaible leads a team providing custom chemistry testing services, including extractables/leachables, materials characterization, and toxicological risk assessments. She has worked in the pharmaceutical, medical device, environmental, and R&D industries, amassing more than 20 years of analytical experience in GLP, GMP, FDA, and ISO-regulated laboratories. Schaible is actively involved in standards development and serves as an international and U.S. delegate for TC 194/WG14, the technical committee for ISO 10993-18.

Steve Kirberger joined NAMSA in March 2025, following the acquisition of WuXi AppTec’s U.S. Medical Device Testing operations. He had been with WuXi AppTec’s Analytical Chemistry department in St. Paul, Minn., since 2020. Dr. Kirberger primarily analyzes extractables and leachables data of medical device extracts using liquid chromatography/mass spectrometry (LC-MS) and gas chromatography/mass spectrometry (GC-MS) techniques. Before working for WuXi AppTec, he earned his Ph.D. from the University of Minnesota studying biological systems using synthetic fluorine-containing probe molecules and fluorine-labeled proteins. He also has post-doctoral experience in a protein engineering laboratory and previous industry experience developing formulations for infection prevention.