Per- and polyfluoroalkyl substances, better known as PFAS, are a class of more than 12,000 substances found in a wide variety of products, including medical devices and their packaging. PFAS have become particularly crucial in medical device tubing due to their desirable properties like low friction, flexibility, and resistance to heat and chemicals. 

However, PFAS, also known as “forever chemicals,” have been heavily scrutinized for their environmental and health impacts, and regulators seem poised to crack down on their use. In 2022, the world’s largest manufacturers of these substances announced they would stop producing the substance by the end of 2025. Together with the regulatory warning signs, this has caused panic among medical device manufacturers, who have come to rely on the unique properties that PFAS bring to their product. 

Now, the medical device industry faces a daunting challenge to find alternatives to PFAS before regulators align, supply becomes limited, or the substances are further restricted. 

The PFAS Regulatory Landscape

There are proposals and ongoing discussions regarding PFAS restrictions in both the United States and European Union but no federal (U.S.) or EU-wide bans specifically targeting medical device PFAS have been fully enacted. However, regulatory scrutiny is increasing.

In February 2023, the European Union proposed Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulations, which would impose bans on more than 10,000 specific PFAS used in several industries and sectors. Other PFAS have already been restricted in the EU under the Persistent Organic Pollutants (POPs) regulation. So far, these regulations have focused broadly on environmental and consumer products and have not affected the medical device industry. But as awareness of potential risks associated with PFAS have increased, regulatory scrutiny has reached many more industries, including medical devices.

In the United States, PFAS may not make the list of immediate regulatory priorities, but state-level laws can be introduced anytime. For example, California has already banned the sale of many consumer items containing intentionally added PFAS.

Many different stakeholders have called for more PFAS regulation. Consumers are worried about the effects these chemicals have on their health, and governments are worried about the risks. Medical device manufacturers may believe they can continue to use PFAS in certain territories, but regulation looks certain to become widespread. The EU will likely introduce this first. A report by the European Environment Agency claimed that forever chemicals can lead to issues such as “liver damage, thyroid disease, obesity, fertility issues, and cancer.” 

Supply Chain Issues 

Regulation isn’t the only threat looming over PFAS use in medical devices; supply chain issues are another concern. PFAS manufacturers and companies producing products containing these substances have settled claims in the United States and Europe over many years. As regulatory and reputational scrutiny ramps up, the supply of these materials could be severely limited. It is conceivable that larger companies with abundant resources could stockpile enough PFAS to delay any replacement strategies. However, as medical devices have an expiry date, this tactic will only work for so long. Unfortunately, issues with the supply chain will hit the smaller medical device manufacturers hardest, as the larger companies will have the resources to hold out for longer or buy in bulk.

Regardless of a device manufacturer’s size, the best approach will be to tackle the problem directly, rather than ignore it and hope a solution presents itself. 

Challenges in Identifying PFAS Replacements 

As regulatory discussion continues and manufacturers rethink their PFAS strategies, medical device companies are poised for an abrupt impact. This means the challenge of replacing these substances becomes both immediate and complex. One of the problems is the widescale utility of PFAS chemicals.

PFAS substances are known for their chemical resistance, heat resistance, durability, lubricity, and biocompatibility. No known materials can replicate this combination of properties and attempts to reformulate products to eliminate or reduce their PFAS content will be extremely challenging without compromising performance or safety. 

Finding a replacement will also increase costs, as companies must ensure that any redesigns meet regulatory requirements. Finally, medical device manufacturers face potential reputational risk as stakeholders—from healthcare providers to the general public—become more concerned with products containing PFAS. 

Solutions for a PFAS-Free Future

Finding solutions for medical devices that do not contain any PFAS materials is as crucial as it is challenging. No immediate answer appears to be on the horizon, and the industry will likely need to work together to avoid major setbacks in production and device availability. The following steps can help manufacturers prepare for and mitigate impending disruption. 

1. Establish a worst-case scenario: Assessing the effect a PFAS ban may have on product lines is a crucial first step. Manufacturers should determine which of their existing products contain PFAS by talking to suppliers to establish a thorough understanding of material composition. This may require lab testing to verify exactly which products extract PFAS. With this information, manufacturers can plan for the various scenarios where PFAS are banned or restricted.

Manufacturers should also assess supply chain vulnerabilities and product availability. This will help identify potential bottlenecks and dependencies and facilitate the creation of backup plans that can minimize disruptions. 

2. Innovate with materials: After confirming the potential areas of concern, manufacturers can work on identifying alternatives to PFAS. The most straightforward strategy is to bypass PFAS altogether by using other materials. This might require switching to natural materials or other synthetic options. Medical device manufacturers must consider potential product redesigns and ensure devices maintain their performance and safety. Innovating entirely new materials would yield the greatest rewards but it remains the most difficult and costliest option, as it would require extensive R&D investment. 

3. Testing and validation: When manufacturers identify alternative materials, they must rigorously test and validate them. Testing includes biocompatibility, chemical characterization, and ensuring that any new materials used meet the established technical and safety standards required for medical devices. Advanced analytical techniques should be deployed to ensure new designs do not compromise safety. 

4. Embrace collaboration: Any restriction on the availability of PFAS materials will affect the entire industry. Collaboration across academia, regulatory agencies, and device manufacturers is required to find safe and effective solutions as quickly as possible. A safety-first approach and experience navigating complex regulatory issues will be critical as these groups define the relationship between the industry and PFAS in future years.

A Final Word on PFAS

Ignoring a problem rarely makes it go away, and PFAS are no exception. Medical device manufacturers would do well to ensure they’re fully prepared for the transition away from PFAS well in advance. New regulation usually comes with a grace period, but active industry discussions to withdraw from PFAS manufacturing by the end of this year should emphasize how timely this issue has already become. Manufacturers who address the issue sooner rather than later can gain a jump on competition and build a comprehensive action plan well before PFAS supplies are restricted or limited.

By removing PFAS from devices, manufacturers will also produce more sustainable, environmentally-friendly products, reducing the potential for legal or reputational risk and improving their long-term appeal. 

The bottom line is this: The PFAS phase-out presents a huge challenge for medical device manufacturers. These compounds are used to make many different devices—i.e., anesthetic delivery systems, surgical meshes, guidewires and filters, and dialysis equipment—safe and comfortable for patients. 

Addressing this challenge will require reassessing the manufacturing process and fundamentally rethinking the industry’s operations. This change will require meticulous planning, sustained innovation, and concentrated testing to ensure that products remain effective and safe after PFAS have been phased out. Manufacturers must collaborate with academia, trusted lab partners, and each other to provide a seamless transition that will improve public health and environmental sustainability.

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, including over 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. 

Dr. 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. Prior to working for WuXi AppTec, he received 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.