Your cart is currently empty!
What are PFAS?
Per- and poly-fluoroalkyl substances (PFAS) are a group of man-made chemicals that have been used in industry and consumer products worldwide since the 1940s. This group contains over 14,000 chemicals with multiple fluorine atoms attached to an alkyl chain. Perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) are two of the most widely used and studied chemicals in the PFAS group.
PFAS are present in our everyday lives. The most common consumer products containing PFAS include non-stick cookware, water-repellent clothing, stain-resistant fabrics and carpets, cosmetics, firefighting foams, and products that resist grease, water, and oil. Among the general population, the primary sources of exposure are food, drinking water, and house dust. Due to their strong carbon-fluorine bonds (one of the strongest chemical bonds in organic chemistry), PFAS are highly persistent in the environment and the human body, explaining why they are called “forever chemicals.”
Use of PFAS in Medical Devices
PFAS are used in medical technologies due to their combination of unique properties, including, but not limited to, chemical resistance, heat resistance, durability, lubricity, rigidity, and low friction coefficient. They are used in a wide range of medical devices, including catheters, pacemakers, wire coatings in radiological machinery, surgical sutures (e.g., PTFE pledgets), hernia meshes, ophthalmic products (e.g., contact lenses), medical tapes and wound dressings, blood bags, and medical device packaging.
Some PFAS that are used in medical devices include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxy alkanes (PFA), and specialty fluorinated lubricants (non-exhaustive list). Therefore, PFAS can be used in medical technologies either in a component or coating of a component of the final medical device, as a processing aid used during device manufacturing, or in their packaging.
Why Are We So Concerned About These Chemicals?
Many adverse health effects have emerged from studies of people exposed to PFAS. Some effects have greater certainty (i.e., strength of association) as they have been observed across different populations and are supported by findings in experimental preclinical models. These include developmental effects affecting the fetus, reduced response to vaccines, thyroid disease, increased cholesterol levels, liver damage, and increased risk of some cancers, including kidney and testicular cancer (source: https://www.eea.europa.eu/publications/emerging-chemical-risks-in-europe). Effects on the immune system appear to be the most critical, i.e., appearing at the lowest exposure doses.[i]
Current Regulatory Landscape
Due to their persistence in the environment, bioaccumulation, widespread occurrence, and toxicological concerns, worldwide regulatory bodies have undertaken measures to restrict the use of PFAS.
European Union
In the EU, the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation is a critical mechanism for managing chemical risks. Some PFAS are already regulated under the REACH Regulation, such as PFOA, perfluorinated carboxylic acids (C9-14 PFCAs), and PFHxS, which are on the REACH Candidate List of substances of very high concern (SVHC). Furthermore, a harmonized classification under the CLP Regulation is available for 41 PFAS.
In January 2023, Germany, the Netherlands, Denmark, Sweden, and Norway submitted a comprehensive proposal for a restriction on the manufacture, market placement, and use of PFAS to the European Chemicals Agency (ECHA), thus initiating a restriction procedure under REACH. The aim of this restriction is to ban the production and use of a wide range of PFASs–as much as possible. This includes placing products containing PFAS on the EU market, following the precautionary principle. Temporary derogations may be granted for selected products and uses for which no alternatives currently exist. However, to date, it is not known whether medical devices will be affected or not by these temporary derogations. Two restriction options (ROs) have been assessed. A complete ban with no derogations and a transition period of 18 months (RO1), and a complete ban with use-specific time-limited derogations (18-month transition period plus either a five- or 12-year derogation period). The Agency’s scientific committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are currently evaluating the proposed restriction together with the numerous comments (5,600+) received from the public consultation. Following this consultation, alternative restriction options, other than a full ban or a ban with time-limited derogations, are being considered. These could be conditions to be met to allow for the continued manufacture, market placement, or use of PFAS instead of a ban, or conditions that must be met for the manufacture, market placement, or use of PFAS until alternatives are available. This assessment will be carried out for medical devices, provided such information has been brought forward in the consultation.[ii]
Considering the proposal’s complexity, the restriction is estimated to come into force no earlier than 2029-2030 (initial timeline: 2026/2027). More information on the proposed restriction and ongoing assessment can be found on the ECHA website.[iii]
United States
In the US, PFOA and PFOS have become the primary focus of regulatory efforts rather than the entire PFAS group. Among the main recent regulatory developments, the US EPA designated on April 17, 2024, PFOA and PFOS–including their salts and structural isomers–as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).[iv] This classification is significant, as it allows the EPA to pursue those responsible for PFOA and PFOS pollution.
On April 10, 2024, the EPA announced limits for six types of PFAS in drinking water under its National Primary Drinking Water Regulation (NPDWR).[v]
In January 2025, the EPA announced the automatic addition of nine per- and polyfluoroalkyl substances to the list of chemicals covered by the Toxics Release Inventory.[vi]
Impact on Medical Device Manufacturers
The increasing restriction of PFAS use worldwide, together with the foreseeable complete ban in the EU, will significantly impact the medical devices sector. The first and most significant impact would be a shortage of lifesaving medical technologies if no alternatives are available.
Regulatory restrictions on PFAS could notably lead to supply chain disruptions, with medical device manufacturers facing critical component or raw material shortages. Even if medical devices were to be exempted from the EU REACH restriction, the use of PFAS would still represent a challenge for manufacturers due to PFAS suppliers stopping production of these chemicals. For instance, 3M, a leading US supplier of PFAS, announced in 2022 it will exit PFAS manufacturing and work to discontinue the use of PFAS across its product portfolio by the end of 2025.[vii]
In its position paper published in September 2023, MedTech Europe warned that the current PFAS restriction proposal would significantly impact 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.[viii] Therefore, medical device manufacturers must urgently work on finding alternatives to PFAS in their devices.
Frequently Asked Questions (FAQ)
How do I know if my device contains PFAS?
The PFAS category that is the subject of the restriction proposal in the EU is defined as: Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it). This definition is similar to the OECD definition derived in 2021, which reads as: “PFASs are defined as fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any H/Cl/Br/I atom attached to it), i.e. with a few noted exceptions, any chemical with at least a perfluorinated methyl group (–CF3) or a perfluorinated methylene group (–CF2–) is a PFAS.” For the restriction proposal, however, one exception is introduced. The exception concerns certain fully degradable PFAS subgroups that only contain some specific structural elements.[ix]
NAMSA can help identify the presence of PFAS in your devices, the potential safety concerns and the foreseeable regulatory impacts.
My device contains PTFE, how will ongoing PFAS regulations impact me?
It is unclear to date whether PFAS will be strictly banned in the EU for all types of products, or if medical devices will be subjected to derogations. Even if derogations are granted for medical devices, the supply chain could be disrupted in the coming years, with suppliers stopping the manufacture of PFAS, leading to an increased demand for alternative materials. It is therefore recommended to start searching for alternative materials as soon as possible.
In case of material change on an already approved and marketed device, what are the regulatory requirements?
Changes to device design, materials, or manufacturing processes can impact a medical device’s performance, stability, biocompatibility, and sterility. In the EU, if the change is considered substantial per the Medical Device Regulation (MDR), your notified body must be alerted, and a new conformity assessment and regulatory approval may be required.
In the US, the Food and Drug Administration (FDA) has issued a guidance to help manufacturers decide when to submit a 510(k) for a change to an existing device.[x]
NAMSA can help evaluate material alternatives and changes from regulatory, biological safety, and clinical perspectives.
[i] European Food Safety Authority (EFSA). Scientific Opinion. Risk to human health related to the presence of perfluoroalkyl substances in food. EFSA Journal 2020;18(9):6223. Adopted: 9 July 2020. doi: 10.2903/j.efsa.2020.6223. Accessed February 13, 2025.
[ii] European Chemicals Agency (ECHA). Progress update on the per- and polyfluoroalkyl substances (PFAS) restriction process. 20 November 2024. Accessed February 13, 2025. https://echa.europa.eu/documents/10162/67348133/pfas_status_update_report_en.pdf/fc30b694-cfb1-e9ed-7897-d9f3e4ef9ab7?t=1732088416751
[iii] European Chemicals Agency (ECHA). Per- and polyfluoroalkyl substances (PFAS). Accessed February 13, 2025. https://echa.europa.eu/hot-topics/perfluoroalkyl-chemicals-pfas
[iv] United States Environmental Protection Agency (US EPA). Emergency Planning and Community Right-to-Know Act (EPCRA). Designation of PFOA and PFOS as hazardous substances under CERCLA Release Reporting Requirements Factsheet. Accessed February 13, 2025. https://www.epa.gov/epcra/designation-pfoa-and-pfos-hazardous-substances-under-cercla-release-reporting-requirements#:~:text=On%20April%2017%2C%202024%2C%20EPA,Compensation%2C%20and%20Liability%20Act%20(%E2%80%
[v] United States Environmental Protection Agency (US EPA). Safe Drinking Water Act. Final PFAS National Primary Drinking Water Regulation. Accessed February 13, 2025. https://www.epa.gov/sdwa/and-polyfluoroalkyl-substances-pfas
[vi] United States Environmental Protection Agency (US EPA). News Releases – January 3, 2025. EPA Adds Nine Additional PFAS to the Toxics Release Inventory. Accessed February 13, 2025. https://www.epa.gov/newsreleases/epa-adds-nine-additional-pfas-toxics-release-inventory
[vii] 3M News Center. Press Releases. December 20, 2022. 3M to Exit PFAS Manufacturing by the End of 2025. Accessed February 13, 2025. https://news.3m.com/2022-12-20-3M-to-Exit-PFAS-Manufacturing-by-the-End-of-2025
[viii] MedTech Europe. MedTech Europe Position on the Proposal for A REACH Universal PFAS Restriction. Dated September 7, 2023. Accessed February 13, 2025. https://www.medtecheurope.org/resource-library/medtech-europe-position-on-the-proposal-for-a-reach-universal-pfas-restriction/
[ix] European Chemicals Agency (ECHA). Annex XV Restriction Report. Per- and polyfluoroalkyl substances (PFASs). Version 2 dated March 22, 2023. Accessed February 13, 2025.
[x] U.S. Department of Health and Human Services. Food and Drug Administration. Center for Devices and Radiological Health. Guidance Document. Deciding When to Submit a 510(k) for a Change to an Existing Device. Dated October 2017. Accessed February 13, 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device
