PFAS in Medical Devices: What You Need to Know
Update: September 1, 2026
The FDA has updated this page with a new Frequently Asked Questions (FAQs) section. Scroll down for answers to common questions about PFAS in medical devices.
The FDA reviews and monitors the safety and effectiveness of medical devices, including devices that contain materials from the PFAS (per- and polyfluoroalkyl substances) chemical family. The PFAS materials used in devices are often plastics known as fluoropolymers. This page explains what fluoropolymers are, why they are used in medical devices, and how the FDA has determined their safety.
Key Takeaways
- Fluoropolymers used in medical devices are not the same as the PFAS linked to environmental contamination or health concerns. They differ in chemical structure, molecular size, and how the body reacts to them.
- Certain materials, like large-molecule PFAS (fluoropolymers), are critical components of life-saving medical devices, including catheters, cardiovascular implants, tubing and wound dressings, because of their unique properties including biocompatibility, durability, electrical resistance and lubricity.
- The FDA’s determination based on available scientific studies is that there is no reason to restrict the continued use of fluoropolymers in medical devices.
What are PFAS?
PFAS are a large group of more than 15,000 chemicals that are used in a variety of products. They are not all the same. Some PFAS, typically those chemicals comprised of small molecules, have been linked to health concerns and have been detected in drinking water and other parts of our environment.
The PFAS used as components in medical devices are different. Many medical devices rely on plastic materials comprised of large molecules (fluoropolymers), which are part of the PFAS family and have been safely used for decades.
Why Are Fluoropolymers Used in Medical Devices?
Medical devices are critical components of health care delivery. Fluoropolymers have unique properties that are essential for devices to function. Currently no other materials exist that can perform the same critical roles in medical devices.
They provide:
- Lubricity (slipperiness) for devices such as the stents used to treat heart and blood vessel problems, and delivery systems used in minimally invasive surgical procedures.
- Electrical insulation, for example, in the wires that lead from a pacemaker to a person’s heart.
- Biostability, allowing medical devices to remain in the body for long periods of time without the likelihood of breaking down. Degradation of medical devices in the body could lead to pieces of the devices breaking off and potentially causing life-threatening medical issues for patients.
What Types of Devices Use Fluoropolymers?
Fluoropolymers are found in a wide range of medical devices, including:
- Cardiovascular implants such as stents and vascular grafts
- Catheters and guidewires used in minimally invasive procedures
- Tubing and wound dressings
- Other devices that require durable or low-friction surfaces
The role that fluoropolymers play, and their level of patient contact, varies significantly across these device types. An implanted cardiovascular device, a temporary catheter, and an external wound dressing involve very different patterns of use and exposure. The FDA considers those differences when evaluating device safety.
The fluoropolymers used in medical devices are typically comprised of molecules that are too large to cross through cell membranes and, as a result, are very unlikely to cause toxicity to patients.
How Does the FDA Evaluate These Devices Before and After Market?
The FDA conducts premarket review and post-market monitoring of medical devices. For devices that do not require premarket review, the FDA oversees them through safety monitoring and adverse event reporting systems. The FDA considers:
- How the device is used and how it contacts the body
- How long the device is in contact with the body
- Whether materials could migrate or be released from the device
- Whether the overall benefits outweigh the risks for patients
The FDA monitors the safety of fluoropolymers in medical devices based on available scientific information. We will update this page as appropriate to keep the public informed as additional information becomes available.
Frequently Asked Questions
Find answers to common questions about PFAS in medical devices below:
No. The term PFAS is used to describe a very broad class of chemicals that are characterized by having at least one carbon-fluorine bond. In the same way that the term carbohydrate (or “carbs”) can be used to classify everything from table sugar to cellulose (the main component of wood), the properties of PFAS chemicals are just as wide-ranging.
PFAS in the form of fluoropolymers have been used as materials of construction in medical devices since the 1950s. They are now used in many thousands of devices from catheters to pacemakers, and no toxicity issues have been connected to the use of fluoropolymers in devices.
The FDA has investigated this area closely through the post-market monitoring program for all marketed medical devices. The FDA also commissioned an outside research organization, called ECRI, to independently study polytetrafluoroethylene (PTFE), the most widely used PFAS material in medical devices.
ECRI collected data from over 1,800 health care provider organizations around the country and over 1,750 published and peer-reviewed scientific articles relevant to the safety profile of PTFE in medical applications. The ECRI review in 2021 found no conclusive evidence of patient health issues associated with PTFE as a material.
The FDA is not aware of any evidence that suggests the fluoropolymer PFAS materials in medical devices have harmful public health effects, and the FDA has determined there is no reason to restrict their use in devices.
The FDA regulates medical devices as finished products, not the individual materials used to make them. Whether a material is safe depends on how it is used in a device.
There are several regulations and requirements that manufacturers of medical devices must follow, including the reporting of certain malfunctions or adverse events to the FDA. In some cases, devices may be temporarily or permanently removed from the market if the risk of using the device outweighs the benefit for the patient. Other products may require specific post-marketing clinical studies to be conducted.
PFAS in the form of fluoropolymers remain essential materials for many devices. There is considerable research being conducted to find alternatives, but in most cases, no other materials have been shown to possess the combination of unique properties that are necessary for their essential function in medical devices.
Imagine a patient who has a very sick heart: she may have a stent in an artery. Her metal stent is likely coated in a fluoropolymer (for example, PTFE) to ensure it does not cause blood clotting. A guidewire coated in PTFE to make it slippery enough to safely move through the vessels would have been used to place the stent during her original surgical procedure.
PFAS fluoropolymers have been used in medical devices for roughly 75 years, and their use has grown as devices have improved over time. The FDA is not aware of any evidence that fluoropolymer PFAS materials in medical devices are harmful and has determined there is no reason to restrict their use in devices.
Several resources are available if you have further questions. You may also contact the Center for Devices and Radiological Health’s Division of Industry and Consumer Education (DICE). If you have a problem with a medical device, please report the problem to the FDA through MedWatch.