The European Chemicals Agency (ECHA) is presently in the process of evaluating a proposal to prohibit per- and polyfluoroalkyl substances (PFAS), a category of substances that are known for their extended environmental persistence and are highly biopersistent. This review has incited substantial discussion regarding the safety of these substances, as research indicates that they may have adverse effects on human health. PFAS are essential in medical technology products, as they offer advantages such as resistance to friction, infection, and blood clotting. Medical devices, including catheters, guidewires, and stents, are frequently coated with polytetrafluoroethylene (PTFE). Nevertheless, there is an increasing need to identify alternatives and eliminate PFAS from the healthcare supply chain, despite their significance.
Considering the regulatory pressure, it is imperative for companies to assess whether the advantages offered by PFAS are indispensable for the operation of their devices. This necessitates reconsidering the initial decision to employ PFAS and ensuring that it is legitimate in the current environment. As original equipment manufacturers (OEMs) investigate the replacement of PFAS with alternatives such as silicone, the selection of appropriate materials for specific applications could be improved through early collaboration with new vendors. It is essential to have technical and regulatory expertise when selecting new suppliers. On the other hand, organizations must also evaluate their long-term consequences. Medical device manufacturers can ensure the efficacy and safety of their products while transitioning away from PFAS by strategically selecting alternatives and collaborating with knowledgeable vendors.
