 Introduction & Forever Chemicals This white paper explores the history of Per- and polyfluoroalkyl substances (PFAS), how they are used in medical technology, why regulatory bodies have pushed for their removal, and strategies for medtech companies to successfully manage this transition.  Before we can begin, we need to understand what ‘Forever Chemicals’ are. The term Forever Chemicals is a nickname which refers to a class of thousands of man-made chemical compounds initially developed in the 1930s which have the characteristic of being able to withstand a wide variety of environment and use cases without degrading. These chemical compounds also don’t break down naturally like other chemicals, therefore donning the name ‘Forever Chemicals’. Forever chemicals can be broken down into two main groups:
For this white paper, we are intentionally focusing on the Forever Chemical group PFAS. This white paper also includes the FDA position on PFAS use in medical devices published 8.6.2025. What is PFAS Per- and polyfluoroalkyl substances (PFAS) are synthetic chemicals extensively used in various industrial and consumer products due to their water- and grease-resistant properties. PFAS uses a carbon fluoride bond as the core of the substance, as a result it can be developed into endless combinations. In 2021, the Organization for Economic Co-operation and Development (OECD) out of France released a revised definition of PFAS, “PFAS are fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any H/Cl/Br/I atom attached to it)”. Simply put – PFAS substances were designed to resist heat, water, and oil – they verge on being indestructible. PFAS has been integral to numerous industries and products, including non-stick cookware, water-repellent clothing, stain-resistant fabrics, firefighting foam and coatings and plastics which rely on lubricious properties. While PFAS can show up in an almost endless combination of compounds, the most popular are:
A Brief History of PFAS The origin of PFAS dates to 1938, when DuPont accidentally discovered PTFE, later branded as Teflon. Over the following decades, PFAS rapidly gained popularity: · 1940s–1950s: 3M and DuPont began mass production of PFOA and PFOS
· 1970s: research by 3M begins to find PFOA and PFOS are toxic to both animals and humans · 1980s–1990s: Environmental and health risks emerged. Studies linked PFAS to liver damage, birth defects, and groundwater contamination o Research at 3M proves that employees have PFOA and PFOS in their blood. DuPont discovers that PFOA passes from a mother to her unborn baby via the umbilical cord.
Understanding PFAS Use Case The visual diagram below, developed by Jamine Ye Han on behalf of Manufacturing Dive, depicts the four key types of PFAS and how they are commonly used.  Source chart: Jasmine Ye Han/ Manufacturing Dive *As of the writing of this article U.S. manufacturers have already begun phasing out the use of PFOAs in their products, especially those which are consumer facing. As an example, 3M began phasing out PFOS from its popular Scotchgard product circa 2000. PFAS Manufacturers The purpose of this section is not to provide an all-encompassing, or exhaustive, list of manufacturers across the globe. This section is intended to provide a glimpse into the manufacturers and the products which utilize said materials, which furthers our understanding of how PFAS make up a wide array of additives in many products and or systems across dozens of industries. USA
PFAS Manufacturing Digest The development and manufacturing process of PFAS can be done via several different processes and involves numerous stages including synthesis, polymerization, and finishing processes. Below is a cursory overview of these stages: 1. Synthesis of Monomers
The synthesized monomers are then polymerized to form the desired PFAS polymer. This can involve several methods, such as:
Once the polymer is formed, it undergoes various finishing processes to achieve the desired properties and forms:
The final PFAS products are then applied to various substrates or used in specific applications. This can involve:
Challenges Associated with Manufacturing PFAS? Manufacturing PFAS presents several significant challenges, primarily due to their environmental persistence, potential health impacts, regulatory hurdles and technical complexities. As Ryan Zelhofer, manager of sustainability, wrote in Supply Chain Brain’s article titled “PFAS Challenges and Solutions”, Zelhofer shared “PFAS regulations are likely to continue, and will accelerate the need for transparency and detailed substance-level data. A future is fast approaching where reactive compliance will not be a sustainable strategy”. PFAS (per- and polyfluoroalkyl substances) present a range of complex challenges which span environmental, health, technical, economic, and societal domains. One of the most pressing concerns is their environmental impact. These compounds are often referred to as "forever chemicals" due to their resistance to natural degradation, leading to persistent contamination of water, soil, and air. They also bioaccumulate in living organisms, raising concerns about their harmful effects as they move up the food chain. As global awareness grows, manufacturers face increasing pressure to comply with strict environmental regulations, such as those set by the U.S. Environmental Protection Agency (EPA) and the European Chemicals Agency (ECHA), which require improved waste management and the development of safer alternatives. Health and safety issues further complicate PFAS use. Compounds like PFOA and PFOS have been linked to a variety of health problems, including cancer, liver damage, immune dysfunction, and developmental issues. Protecting workers who handle these substances requires robust safety protocols to minimize exposure. On the technical side, PFAS synthesis is highly specialized, relying on complex processes such as electrochemical fluorination or telomerization, which demand precise equipment and conditions. The production process also generates numerous by-products, some of which are similarly persistent and toxic, making their control and disposal especially difficult. Quality control adds another layer of complexity, as many PFAS applications demand exact chemical specifications. Economic challenges are also significant. The costs associated with regulatory compliance, safety measures, and environmental controls can be substantial. At the same time, investing in the development of non-PFAS alternatives requires major financial commitments and long timelines. As regulatory and consumer pressures grow, the market is increasingly shifting toward safer alternatives, affecting demand for traditional PFAS-based products. Disposal and remediation of PFAS waste are particularly difficult because of their chemical stability. High-temperature incineration is often necessary, but it is both expensive and energy-intensive. Moreover, cleaning up PFAS-contaminated sites remains a costly and technically complex process, with many remediation technologies still in development. Compounding these issues are supply chain concerns. Sourcing high-purity fluorinated raw materials is both difficult and costly, and global supply chain disruptions can significantly impact the availability and price of essential inputs for PFAS manufacturing. Lastly, public perception and corporate responsibility play a critical role in shaping the future of PFAS. Growing awareness of their environmental and health impacts has damaged the reputation of manufacturers and reduced demand in some sectors. Companies are now expected to demonstrate greater transparency and accountability, taking full responsibility for the lifecycle impacts of their products. Addressing these interconnected challenges requires a comprehensive, multi-faceted approach that balances innovation, safety, and sustainability. PFAS Use in Medical Devices In the medical device industry, PFAS are used extensively due to their unique combination of chemical resistance, low friction, high thermal stability, and biocompatibility. One of the most common applications is in catheters and guidewires, where PFAS—particularly polytetrafluoroethylene (PTFE)—is used as a coating to reduce friction. This friction reduction makes it easier for these devices to navigate through blood vessels and bodily passages, enhancing both performance and patient safety. In vascular grafts and stents, expanded PTFE (ePTFE) is favored for its biocompatibility and its ability to resist clot formation and infection, making it ideal for critical cardiovascular applications. Surgical meshes, which provide structural support to weakened or damaged tissue, also benefit from PFAS materials because of their durability and resistance to bodily fluids. Example: PTFE Coated Foley Catheter 30 ml & PTFE Surgical Mesh
Implantable medical devices frequently incorporate PFAS due to their chemical inertness and minimal reactivity with biological tissues, which helps lower the risk of adverse reactions and extends the device's functional life. Similarly, PFAS coatings are applied to medical devices like needles and syringes to create lubricious surfaces that reduce insertion pain and minimize tissue damage. PFAS is also used in the manufacture of medical tubing for applications requiring high flexibility and chemical resistance, such as infusion pumps and drainage systems. In prosthetics, components that involve joint movement—such as hip and knee replacements—take advantage of PFAS's low friction and high wear resistance to improve performance and durability. Additionally, PFAS is found in seals and gaskets used within various devices where long-term leak-proof performance and chemical resistance are critical. While these properties make PFAS highly valuable in medical technology, growing awareness of their environmental and health risks has led to increased scrutiny. Regulatory agencies and manufacturers are now exploring safer alternatives and working to limit PFAS use where possible, without compromising the safety and effectiveness of medical devices. Editorial Note: As of 8/6/2025 the FDA has taken a formal stance as it relates to PFAS, in particular those materials which are typically used in association with medical technology. FDA indicates: "PFAS are a very broad and diverse group of chemicals with wide industrial uses. There are thousands of different kinds. The PFAS used in medical devices are not the same as those identified as being potentially harmful to people in other contexts. The PFAS materials used in medical devices (known as fluoropolymers) have a long history of use. The best-known of these materials is polytetrafluoroethylene (PTFE), which is used in multiple consumer products, and was first used in a medical device in the 1950s. The FDA’s evaluation is that currently there is no reason to restrict their continued use in devices." Read entire FDA article HERE. Environmental, Public and Economic Impact of PFAS The environmental, public health, and economic impact of PFAS (per- and polyfluoroalkyl substances) has become a growing global concern as awareness of these "forever chemicals" continues to rise. As scientific evidence mounts linking PFAS exposure to serious health risks and ecological harm, governments, industries, and communities are grappling with the long-term consequences. From the escalating costs of cleanup and regulatory compliance to the strain on public health systems and corporate accountability, the far-reaching effects of PFAS contamination present a complex and urgent challenge. Below is a summary of a variety of considerations relating to the impact of PFAS globally. Reduction in Environmental Contamination PFAS are highly resistant to environmental degradation, leading to their accumulation in water, soil, and living organisms. Removing PFAS manufacturing from the USA is expected to lead to a significant decrease in environmental contamination levels. This reduction would have a beneficial impact on ecosystems, particularly in areas surrounding PFAS manufacturing plants, which often experience the highest levels of contamination. Long-term Environmental Recovery While the immediate cessation of PFAS emissions is a positive step, the long-term recovery of contaminated sites remains a challenge. PFAS remediation is complex and costly, requiring advanced technologies such as granular activated carbon filtration, ion exchange resins, and high-pressure membrane systems. The removal of PFAS manufacturing will not eliminate existing contamination, necessitating sustained efforts and funding for environmental cleanup and restoration. Public Health Impact One of the most compelling reasons for phasing out PFAS manufacturing is the potential reduction in health risks associated with exposure. Studies have linked PFAS exposure to various adverse health outcomes, including increased cholesterol levels, changes in liver enzymes, reduced immune response, thyroid disease, and certain cancers. By eliminating the source of these chemicals, it is anticipated that population-wide exposure will decrease, leading to improved public health outcomes over time. Challenges in Monitoring and Regulation Despite the potential health benefits, challenges remain in effectively monitoring and regulating PFAS levels in the environment and human populations. Robust surveillance systems and stringent regulatory frameworks will be essential to ensure that the phase-out leads to meaningful reductions in exposure and health risks. Additionally, public health initiatives must be implemented to educate communities about the risks of existing contamination and the importance of reducing exposure from legacy sources. Economic Impact Industries that rely heavily on PFAS, such as manufacturing, aerospace, electronics, and textiles, will face significant challenges in transitioning to alternative substances. The phase-out could lead to increased production costs, supply chain disruptions, and potential job losses. Companies will need to invest in research and development to identify and implement viable substitutes that match the performance characteristics of PFAS without the associated risks. Innovation and Market Opportunities Conversely, the push to eliminate PFAS presents opportunities for innovation and the development of safer alternatives. Companies that can successfully create and market PFAS-free products will gain a competitive edge in an increasingly environmentally conscious market. Government incentives and funding for green chemistry and sustainable manufacturing practices could accelerate this transition, fostering a new era of environmentally friendly industrial processes. Technological and Substitution Challenges Development of Alternatives Finding alternatives to PFAS that provide similar performance characteristics remains a significant challenge. PFAS are prized for their unique chemical properties, including resistance to heat, water, and oil. Alternatives must meet these criteria without posing similar environmental and health risks. Ongoing research in materials science and chemistry is critical to identifying and validating these substitutes. The transition to PFAS-free manufacturing will require substantial investment in new technologies and production processes. Companies will need to retool their operations, which could be capital-intensive and time-consuming. Additionally, regulatory agencies must provide clear guidelines and support to facilitate this transition, ensuring that substitutes are both effective and safe. Alternatives to PFAS Replacing PFAS (per- and polyfluoroalkyl substances) is challenging due to their unique properties, such as water and oil repellency, thermal stability, and chemical resistance. A key to finding a suitable alternative is whether or not it can provide similar functionalities without the environmental and health risks. While the list of materials is extensive, below is a list of categories and examples of materials being explored as replacements for PFAS, especially within the medical device industry: 1. Fluorine-Free Alternatives
An Approach to Replacing PFAS in Medical Device Products Before considering replacement of PFAS from your product, ensure you are up-to-date with the FDA's latest position related to PFAS use in medical technology. Read FDA position HERE. Changing out PFAS (perfluoroalkyl substances) materials in a medical device product typically involves a structured approach to ensure regulatory compliance, safety, and efficacy of the device. While there is not one right, or perhaps wrong, answer in how to address this transition, or change out, below is a general guide on how to proceed. It is highly recommended you seek the advice and counsel of experts in the field of material sciences, engineering, compliance and legal to ensure any PFAS transition process, let alone the one described below, is appropriate for your business and industry. 1. Identify PFAS-Containing Materials
Considerations:
Summary Table of FDA Consideration  Closing & Opinion In an environment where regulatory landscapes are shifting rapidly and public scrutiny around chemical safety is intensifying, proactively addressing the presence of PFAS in medical devices is no longer optional, it’s essential. While the immediate urgency may vary by region or product type, the long-term trajectory is clear: manufacturers that wait to act will find themselves at a significant disadvantage in terms of compliance risk, supply chain disruption, and reputational harm. Getting ahead of these changes means developing a well-structured, forward-looking plan that goes beyond material substitution. It requires organizations to think holistically evaluating not only technical performance, but also regulatory implications, patient safety, environmental impact, and long-term business strategy. A successful PFAS transition plan involves multiple layers of complexity: identifying PFAS compounds across device components and packaging, researching and validating suitable alternatives, reassessing biocompatibility, ensuring continued regulatory compliance, and updating risk management documentation. These efforts must be grounded in science and executed with precision, especially for devices where PFAS plays a critical functional role, such as in catheters, implantable components, or lubricious coatings. The consequences of overlooking even a single variable—whether related to sterilization compatibility or unintended toxicological outcomes—can be significant. To navigate this process effectively, it is critical to bring in the right expertise at the right time. Subject matter experts, including regulatory consultants, toxicologists, material scientists, and quality systems specialists—play a vital role in de-risking the transition and accelerating decision-making. Their knowledge can guide critical evaluations, from selecting and testing new materials to preparing regulatory submissions and aligning with evolving international standards. Engaging these experts early can reduce trial-and-error cycles, avoid unnecessary delays, and ensure a smoother transition with fewer surprises. Ultimately, the move away from PFAS presents an opportunity—not just a challenge. It allows medical device companies to innovate with more sustainable materials, strengthen their compliance posture, and position themselves as responsible leaders in patient and environmental safety. Companies that take a proactive, strategic, and well-supported approach will not only meet regulatory expectations, but also build trust with healthcare providers, patients, investors, and regulators alike. In a world where transparency, safety, and sustainability are increasingly interlinked, leading the transition away from PFAS is both a compliance mandate and a business advantage. Source/ Reference Material & Content Credit: This white paper has been compiled utilizing a wide array of data, reporting and perspectives from the following sources and does not intend to utilize or portray said information as the author or Square-1 Engineering’s primary source content. Source materials are recognized as owned and created by its original source, whereas credit is given as follows:
1 Comment
8/19/2025 01:53:35 am
Great summary of the PFAS. Next to medical device applications, also applications in pharma tech equipment are concerned and will have impact on manufacturing of drugs, vaccines and antibiotics. Leave a Reply. |
About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. |
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