PFAS in healthcare: where they’re used and the challenge of developing alternatives

Exposure to PFAS can also affect human health, with recent studies linking the ‘forever chemicals’ to medical conditions including kidney and testicular cancers, liver damage, high cholesterol, reduced fertility, and weakened immune responses. Combined with heightening regulatory scrutiny and sustainability pressures, press and public awareness and concern around 'forever chemicals' is also coming to the fore, as shown in recent BBC news articles, which will only increase scrutiny. Manufacturers then must continue to look more closely at where PFAS are used and whether alternatives can deliver the same functionality. 

For medical devices, however, replacing PFAS is rarely as simple as finding another material. Alternatives must meet stringent requirements for biocompatibility, sterility, durability, performance and safety, while material changes can trigger extensive testing and regulatory qualification. 

So, where are PFAS used, and what will it take to develop viable PFAS alternatives for medical devices? 

Where can PFAS be found in MedTech?

PFAS are used across a diverse range of medical devices, equipment and healthcare textiles. Their applications range from materials that come into direct contact with patients to components used within complex medical systems. 

Catheters, tubes and guidewires 

Fluoropolymers such as PTFE are used in a range of minimally invasive medical devices, including catheters, guidewires and tubing. 

Their low coefficient of friction can make devices easier to insert and manoeuvre, while their chemical stability and durability can help them perform reliably during procedures. 

ECHA's recent mapping of PFAS uses identifies applications including inner linings and outer coatings for tubes, catheters and guidewires, as well as insulation for reusable electrodes used in endoscopy equipment. 

Implants and cardiovascular devices 

Some of the most technically demanding applications are found in implantable and cardiovascular devices. 

Fluoropolymers are used in applications including vascular grafts, stents, pacemakers and other implantable devices, where their stability and low-friction properties can provide important functional benefits. 

The FDA notes that fluoropolymers have been used in medical devices since the 1950s and highlights properties including lubrication, electrical insulation and biostability as reasons they remain valuable in critical applications. 

This makes these applications particularly challenging for substitution. A material used in a long-term implant cannot simply be replaced because a theoretically suitable alternative exists. Its performance, stability and interaction with the body must be thoroughly understood. 

Surgical gowns, drapes and other medical textiles 

Healthcare textiles can also use fluorinated treatments to provide bodily fluid, oil and water repellence, an important performance characteristic that provides an effective barrier against contaminants. and make cleaning easier. These applications can include surgical gowns, drapes, masks and other protective textiles. 

However, the requirements for these products are different from those of an implant or catheter. This means there may be opportunities for alternative materials, coatings or fabric constructions in some applications. 

Tubing, seals and components in medical equipment 

Fluoropolymers are used in tubing, seals, gaskets, O-rings and other components used for applications such as dialysis and other fluid-handling systems where resistance to chemicals, temperature and degradation is important. One of their most valuable use cases is their low chemical migration properties and their ability to prevent extractables and leachables, an imperative when it comes to product quality and patient/consumer safety.  

PFAS can also be found in components such as the lubricants and processing aids (e.g. mould release) used in manufacture primarily due to properties that ensure stability and durability. These substances, often in the form of fluoropolymers, provide essential functions such as biocompatibility, lubricity, and electrical insulation. They are critical components of devices like catheters, allowing them to function effectively in biological environments. 

These components may not be obvious when manufacturers begin mapping their PFAS footprint, highlighting the importance of looking beyond the main materials within a device. 

Why are PFAS used in medical applications? 

PFAS materials can combine several properties that are difficult to reproduce with other materials. Depending on the application, these can include: 

• Stability 

• Low leachable and extractable content 

• Low friction and lubricity 

• Chemical resistance 

• Thermal stability 

• Durability 

• Low moisture absorption 

• Electrical insulation 

• Water and oil repellence

For a medical device, these properties directly influence how a product performs. A catheter, for example, will need to move smoothly through the body without damaging surrounding tissue while delivering chemical resistance, inertness as well as sterile properties. The right PFAS material will offer these properties, and they cannot be easily replaced by a single material where an application’s success depends on them. 

This is why PFAS substitution needs to be approached differently from simply replacing a fluorinated chemistry with a non-fluorinated one. 

PFAS replacement is an application challenge 

For medical device manufacturers seeking alternatives to PFAS, the central consideration is what function a material performs and whether the component, product or process can be redesigned to remove the PFAS entirely, and if not what are the key material properties needed. 

A viable alternative may require a different polymer, formulation, coating, surface treatment, manufacturing process and product design. 

This design-for-application approach is important because materials that perform well in laboratory testing still need to demonstrate the required performance, safety, manufacturability and durability in the finished medical product. 

For CPI this is where advanced materials development, and process innovation can help bridge the gap between identifying a potential alternative and demonstrating that it is commercially viable. 

What are the PFAS regulations for medical devices?

Regulatory scrutiny of PFAS is increasing internationally. 

In Europe, a broader PFAS restriction is being considered under the REACH Regulation. The proposed restriction covers a wide range of sectors, not just medical applications, although the regulatory process recognises that some uses present greater substitution challenges than others. ECHA's PFAS use mapping highlights the breadth of medical applications under consideration, including implantable and invasive devices, non-invasive devices and medical device packaging. It also identifies areas such as drug delivery devices and medical textiles separately within the wider PFAS use landscape. 

The US FDA,  makes a distinction between the broad family of PFAS and the fluoropolymers commonly used in medical devices. While its current position is that there’s no reason to restrict the continued use of these fluoropolymers in medical devices based on the available evidence this is a narrowed focus that does not consider the hazard they pose in their broader lifecycle pre and post clinical setting (i.e. during manufacture and disposal). 

For manufacturers operating across global markets, this creates a complex landscape as regulatory approaches need to vary by territory. Understanding which PFAS are present, why they’re used and which products they affect is becoming increasingly important for future regulatory planning. 

Why is replacing PFAS so difficult? 

One of the biggest challenges is that medical products can’t compromise on performance or safety under the broader regulations that cover medical devices. 

An alternative material may appear to provide similar chemical resistance or friction performance in laboratory testing, but that doesn’t necessarily mean it’s suitable for use in a medical device. 

Alternatives may need to demonstrate a long list of material properties in combination with commercial and process viability including: 

• Biocompatibility: Materials must be suitable for their intended contact with patients and tissues. 

• Performance: The replacement must deliver the required mechanical, chemical, thermal or surface properties throughout the product's intended lifetime. 

• Sterilisation resistance: Medical devices may be exposed to demanding sterilisation processes, which can affect the properties of polymers and coatings. 

• Durability: For long-term or implantable devices, materials may need to remain stable for years without degrading or releasing unwanted substances. 

• Manufacturing compatibility: A new material may require changes to processing conditions, equipment, tooling or assembly processes. 

Where a material is being directly replaced in a medical device, the qualification process can require extensive testing and validation before it can be brought to market, along with updating technical documentation and resubmission for regulatory approval. These requirements mean that even when a potential PFAS alternative has been identified, the route to commercial market and adoption can be long, shaped by factors such as performance gaps, patient safety and regulatory requirements, qualification timelines, complex supply chains and the need to balance sustainability with clinical needs. 

In the instances where a manufacturer is exploring ways to replace a material that’s indirectly used in the manufacture of a device (e.g. a lubricant) then that could be considered a minor change and less stringent testing maybe possible. This may present a more immediate opportunity for manufacturers to explore sustainable alternatives.