Per- and polyfluoroalkyl substances are otherwise referred to as PFAS. They have received a significant amount of attention and are possibly the most analyzed group of chemicals worldwide. Regulatory agencies in United States, Europe, and others have raised environmental and health concerns regarding PFAS.1-4 As a result, PFAS Regulatory Discussions have increased. They are centered around restrictions, reporting requirements, and lifecycle management requirements.5
Medical devices commonly use PFAS, which makes implementing these potential regulations quite complicated. Regardless, medical device manufacturers must consider how new PFAS regulations may impact the materials they use. They must also consider their supply chains, and product development strategies.3,6
The use of fluoropolymers (including PTFEs) is widespread in devices. For example, PTFE tubing and liners have become irreplaceable components in minimally invasive devices.
As such, manufacturers are confronted with the difficult task of maintaining optimal medical device performance while adapting to evolving global regulations concerning PFAS.
High-molecular-weight fluoropolymers, such as Polytetrafluoroethylene (PTFE) are recognized for their chemical inertness and biocompatibility. On the other hand, smaller molecular weight PFAS are less chemically stable. These can easily be released into the environment (mobile PFAS). These mobile PFAS compounds are associated with environmental persistence. And this is causing regulatory concerns, and prompting manufacturers to evaluate their long-term fluoropolymer strategies.
This article examines how emerging PFAS regulatory discussions may influence the use of fluoropolymers in medical devices, particularly PTFE tubing and liners used in the medical industry. We look at why PTFE remains a critical material that is not easily replaceable. Also, we explore how these restrictions are influencing the PTFE industry. Lastly, we suggest some strategies for regulatory preparedness to ensure continued compliance and device performance. If you are a medical device engineer, a Regulatory Affairs Manager, you will want to read this article to the end.
Understanding the Regulatory Landscape & the Effect on Medical Devices
PFAS are a large class of thousands of chemically distinct substances. They are made up primarily of carbon-fluorine bonds and used in a variety of applications.
Historically, most regulatory attention has been focused on a small number of individual PFAS. These include perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), which were commonly used as processing aids and are associated with potential environmental contamination.8-11
In more recent years, some regulatory agencies have taken a broader definition of PFAS to include fluoropolymers as part of the larger class of PFAS. There is substantial debate among industry associations, regulatory agencies, scientists, and medical professionals about how to appropriately classify and regulate fluoropolymer products, such as PTFE.7
Many industry associations argue that fluoropolymers are fundamentally different than low molecular-weight PFAS substances.
PTFE, for example, is composed of very large, stable polymer chains that have very low solubility, low mobility, and nearly no reactivity with other chemicals. These characteristics contribute to the long-standing use of PTFE in many critical healthcare applications.
Despite these distinctions, manufacturers should remain vigilant when developing regulatory proposals. This is because compliance could ultimately expand to include fluoropolymers, which as noted above are commonly used in the medical devices they manufacture.
Why PTFE Remains Critical for Medical Devices
These potential regulatory changes are so complicated because they involve such an important material. PTFE remains deeply integrated into medical device design, mainly because of its exceptional properties,11-14 which we discuss in more detail below.
Exceptional Lubricity
PTFE provides one of the lowest coefficients of friction among all manufacturing materials. As such, it provides a lubricious surface for navigating catheters, guidewire systems, and delivery devices throughout tortuously shaped anatomy.
Smooth movement of these devices can directly influence the efficiency of a procedure and the amount of control a physician can exert over a procedure. Due to the ability of PTFE to reduce friction, PTFE liners have been used within multilayer catheter shafts to facilitate guidewire movement and device tracking.
Chemical Stability
A medical device will encounter a range of sterilization agents, pharmaceuticals, biological fluids, and a multitude of chemicals during its life. PTFE has excellent chemical resistance. Therefore, PTFE will not lose its integrity during the manufacturing process, storage, or clinical use due to exposure to these chemicals.
Biocompatibility
PTFE has a long history of successfully and safely being used in healthcare applications. Under normal operating conditions PTFE is biologically inert and is therefore suitable for use in many implantable and non-implantable medical devices.
Thermal Performance
PTFE can perform under a wide range of temperatures and withstand demanding sterilization processes. Thermal stability supports flexibility in the manufacturing process as well as provides high device performance.
Durability and Reliability
PTFE liners help support the long-term mechanical performance characteristics of catheters (and similar devices). It also support consistent performance characteristics of devices during complex procedures due to their superior wear and degradation resistance.
Potential Regulatory Impacts on Medical Device Manufacturers
Fluoropolymers currently remain essential materials for many medical technologies. However, emerging PFAS discussions are already influencing strategic planning throughout the medical device industry.9,10,15
One clear sign of change was observed in 2023. 3M, a large producer of fluoropolymers, announced plans to leave the PTFE business entirely by 2025. PTFE is a widely used fluoropolymer. Exiting this market was estimated to account for $1.3 billion in lost annual sales from 3M’s business. It is also estimated that the company would record around $2.3 billion in financial charges related to the exit.16 However, 3M continues to manufacture some 14,000 products that include PFAS and will continue to use unless they find materials that can serve as suitable alternatives. 17
Another large announcement happened in 2025. The world’s largest chemicals corporation, BASF has also announced that it will exit PFAS market by 2028.
At the same time, the European Union has proposed a broad restriction that would effectively ban fluoropolymers that contain PFAS (per- and polyfluoroalkyl substances), including PTFE. The proposal would allow a few temporary exceptions, but those exceptions would end after seven to twelve years.
Whiles these regulation changes have supporters, many in the medical device industry warn that such a ban could cause major problems. They say the medical device sector depends on a reliable supply of certain fluoropolymers. A sudden cutoff or short exemption period could disrupt supply chains and make it hard to find safe, approved alternatives.18
Push Back
Not everyone agrees with the proposed ban.
Fluoropolymer manufacturers are pushing back. These producers argue that fluoropolymers are essential for many uses. They also argue that there are no adequate substitutes for some of their applications. They say the ban could harm industries that rely on these materials and that regulators must consider those impacts before moving forward.16,18,19
Potential Challenges
Regulators may ensure PFAS traceability throughout the supply chain. Therefore, the following challenges might be faced by the manufacturers in the near future:
- Manufacturers may face expanding expectations regarding material disclosure and chemical inventory reporting
- Regulatory affairs teams are placing greater emphasis on traceability throughout the supply chain.
- Regulators and healthcare organizations are paying greater attention to environmental impacts across product lifecycles
Regulatory teams should anticipate increased requests for:
- Material composition data
- Safety documentation
- Environmental assessments
- Supplier declarations
- Risk management analyses
Suppliers capable of providing comprehensive regulatory documentation may gain competitive advantages as compliance expectations increase.
Why the Immediate Replacement of PTFE Is Unlikely
Despite ongoing regulatory discussions, replacing PTFE in many medical applications remains technically challenging.8,11,19
Here are some reasons why:
Performance Gaps and Limited Alternatives
Alternative polymers often fail to simultaneously deliver:
- Ultra-low friction
- High chemical resistance
- Sterilization compatibility
- Mechanical durability
- Long-term stability
While individual materials may match one or two characteristics of PTFE, replicating the complete performance profile remains difficult.
Clinical Risk Considerations
Medical devices are highly regulated products that require extensive testing and validation. Replacing a critical component material may trigger significant design verification, validation, and regulatory submission requirements.
For many manufacturers, material substitution introduces risks that must be weighed against uncertain future regulatory outcomes.
If adequate alternatives cannot be found then patient safety may be the risk.
The Continuing Role of PTFE Liners and Tubing
Throughout the years, PTFE tubing and liners have supported a wide variety of applications, including coronary and peripheral catheters, neurovascular delivery systems, and minimally invasive surgical devices. Their unique combination of lubricity, chemical resistance, biocompatibility, and durability makes them essential components of today’s medical device engineering.
The PFAS regulatory discussions will continue to evolve. At the same time, the critical performance attributes of fluoropolymers in life-saving medical technologies have generally been acknowledged by manufacturers of medical devices.
Future regulatory frameworks are expected to require manufacturers to demonstrate responsible use of materials, to develop extensive documentation, and to disclose information regarding supply chains.
There are many difficulties associated with replacing PTFE. As a result, it is highly likely that fluoropolymer-based materials will continue to play an important role in advanced medical devices for the foreseeable future. However, this may change so manufacturers must be prepared.
How Can Device Manufacturers Strategically Respond?
Rather than pursuing immediate elimination of fluoropolymers, it is important to adopt risk-based strategies that improve preparedness while preserving device performance. Here are some suggestions for accomplishing this:
Maintain Regulatory Awareness
Organizations should continuously monitor PFAS developments across key jurisdictions, particularly the United States and Europe. Early awareness allows companies to adapt proactively rather than reactively scrambling.
Strengthen Supplier Partnerships
Close collaboration with fluoropolymer suppliers can improve visibility into material sourcing, manufacturing processes, and future regulatory developments.
Suppliers with deep expertise in medical-grade fluoropolymer technologies can help manufacturers navigate evolving requirements while maintaining product performance.
Evaluate Material Criticality
Not all fluoropolymer uses carry equal strategic importance. Companies should identify where PTFE provides unique functionality and where alternative materials might be feasible if future regulations necessitate changes.
Invest in Material Innovation
Research programs exploring hybrid constructions, advanced catheter architectures, and novel polymer combinations may help diversify future design options without sacrificing clinical performance. Using lubricious hydrophilic medical device coatings, as an example, could be one such technique.
Develop Long-Term Compliance Plans
Forward-looking companies are creating internal frameworks for PFAS assessment, documentation management, and supply chain transparency. These initiatives can improve resilience regardless of how future regulations evolve.
Conclusion
There are on-going PFAS regulatory discussions affecting the medical device industry. As such, medical device manufacturers need to reconsider the use of Fluoropolymer materials for their medical devices and plan for the changing regulatory landscape. Manufacturers may focus less on immediate replacement of fluoropolymer materials and more on the need for increased transparency and documentation from suppliers. Regardless, there is a need for long-term forward strategic planning.
Medical manufacturers rely on the unique attributes of PTFE materials (such as the use of PTFE tubing and PTFE liners) for many medical applications. This is because these materials have a long history of successful use and excellent product performance.
The most successful strategies for device manufacturers will likely involve:
- being proactive in preparing for regulatory changes associated with PFAS
- collaborating with suppliers to provide the best products possible
- innovating the materials they use for their products
By having an understanding of how the PFAS regulatory landscape is changing, innovating new solutions, and maintaining strong fluoropolymer management programs, device manufacturers can continue to take advantage of the use of PTFE while preparing for any new regulations that may arise.
