The European Chemicals Agency (ECHA) is currently reviewing a proposal to ban an entire class of highly biopersistent substances called per- and polyfluoroalkyl substances (PFAS), known to persist in the environment longer than any other synthetic chemical.
This has sparked a huge debate around the safety of these substances, which studies suggest may have damaging effects on human health. Yet despite the risks, a large part of the conversation concerns whether certain industries, including medical devices, can continue manufacturing products without them.
The future of PFAS in medical devices
PFAS are very important to today’s MedTech products, offering various benefits such as resistance to friction, infection, and blood clots. Polytetrafluoroethylene (PTFE) has become the go-to coating for devices such as catheters, guidewires and stents. Without this coating, the implants would be at high risk of failure or causing clogging.
Yet despite their prevalence and the importance of these materials to many product lines, there is no better time to find alternatives and start phasing out PFAS from the healthcare supply chain. Whether a ban is right around the corner or further down the road, forms of disruption are already happening. Moreover, PFAS-related supply issues, regulatory scrutiny, and legal matters are only expected to worsen in the future.
“The regulatory pressure is still very uncertain on PFAS, but we know something is coming,” says Clement des Courières, regional market manager at Elkem Silicones, a leading provider of advanced materials for the medical device industry.
“Given the pressure, companies who use PFAS in their products should really consider if the functionality brought by PFAS is absolutely necessary for the function of the device – it’s about rethinking why this material was selected in the first place and making sure that this decision still makes sense in the new context. The earlier MedTech companies look at these materials and at potential alternatives, the better for them.”
PFAS alternatives
In a previous article in this series, we discussed whether medical-grade silicone can be a suitable swap for fluoropolymers – the subset of PFAS used widely in the healthcare industry. Silicone is already a very popular material in MedTech due to its chemical inertness and hydrophobicity. Its versatility has lent it to a very wide range of applications, from long-term body implants to wound care, contact lenses, prosthetics, and many more.
Silicone and fluoropolymers share certain similarities and, with the right formulation, could indeed be seen as alternatives for one another in applications like catheters, stents, vascular prostheses, and coatings.
Nevertheless, fluoropolymers bring some unique properties to the table that cannot always be replicated by a substitute. OEMs are advised to focus on the properties of their device which have the biggest impact on its safety and performance and be open to compromising on the supplementary, ‘nice to have’ properties and benefits that fluoropolymers offer.
Start conversations with suppliers early
As OEMs consider the potential of replacing PFAS with alternative materials like silicone, collaborating with new vendors early in the process could increase their chances of selecting the most suitable material for the application from the beginning.
Considering the length of time required to qualify new materials, any opportunity to accelerate the R&D process is important. Many fluoropolymer applications involve higher risk implantable devices, meaning manufacturers may be looking at potentially ten years of R&D – a similar amount of time (and money) as required for new device development.
“This will be a very long process and that's why we encourage companies to start early with the redesign of their products and the phasing out of PFAS,” says des Courières. “We know it will take time until a new set of materials is confirmed and qualified for the applications.”
How to choose the right partner to support your transition
When exploring options with new suppliers, it will be critical to work with companies that can customise products and bring their material science expertise to an open collaboration. They shouldn’t just be trying to sell you a material that may or may not work for your specific application, but a solution to your problem.
Deep application knowledge, regulatory awareness, and material science expertise are all key to Elkem’s approach. “If a company has identified PFAS that they wish to replace in their product, we can look at the properties and the benefits brought by this material and propose something that performs in the closest possible way,” says des Courières.
“When we recommend alternatives, we will keep in mind that the application is a medical device and our deep knowledge of the regulatory context of this industry enables us to propose a material that is already medical-grade or even possibly implant-grade so that the designers have peace of mind that the material will be compliant to healthcare and medical regulations.”
While technical and regulatory expertise are the two most important qualities to look for in new suppliers, it’s also important to think further down the line. Once a redesign is complete and the product has undergone all the necessary tests to deem it safe for patients and fit for use, does your new supplier have what is needed to ensure continuity of supply? This usually calls for a robust industrial footprint.
“Qualifying a new material takes time and is highly resource-intensive for medical devices,” reminds des Courières. “Once it’s qualified, the last thing you want is to have disruptions of supply. Working with a company that can manufacture the same material in different parts of the world can be a good prevention for supply disruption. The other advantage for global customers is that they can be supplied locally but from a global company; they have the same trust in the company but have a local supply for their material.”
Elkem Silicones has more than 65 years of silicone formulation expertise, with many years serving healthcare OEMs with its Silbione™ range of medical-grade materials. These high-quality products are supported by global fully integrated manufacturing infrastructure and a network of formulation experts and toxicologists dedicated to your success during this challenging time.
The impact of Europe’s proposed PFAS ban on medical devices
In this whitepaper, we explore the background of the proposed PFAS regulation and its impact on the medical sector. It also discusses the suitability of silicone as a potential alternative to the types of PFAS used in the medical device industry.
An article written in association with Medical Device Network
