A few years ago, five EU states – Germany, Denmark, the Netherlands, Norway, and Sweden – ignited conversations about restricting PFAS substances. While the early discussions were bold in scope, they initially drew limited attention and caused little disruption. But it didn’t take long before news of those conversations spread, raising real questions about how sweeping the restrictions could be.

For the medical device community, the stakes were clear. Not all PFAS are created equal, and polymeric fluoropolymers like PTFE are in a class of their own. These polymers of low concern (PLCs) are critical for surgical catheter liners where nothing else comes close in performance, reliability, or patient safety. Without them, life-saving procedures wouldn’t be possible.

Even with that reality, uncertainty lingered. Resin suppliers and chemical companies set goals to leave the PFAS market. Major OEMs set ambitious goals to limit PFAS within their supply chains. The drive for alternatives was on, despite the lack of any truly viable option for many applications.

Then, in February 2023, the European Chemicals Agency (ECHA) issued a proposal to restrict all PFAS – thousands of substances, both polymeric and non-polymeric. The potential impact went far beyond Europe. If adopted without exceptions, it could have disrupted industries worldwide and jeopardized essential medical technologies.

Global industry leaders, including Zeus, went to the table with regulators, making the case that certain fluoropolymers have no replacement, are essential for modern healthcare, and should be exempt from restrictions.

Fast-forward to today: the ECHA proposal is still under review, but the USFDA recently stepped forward with its own perspective. It recognizes that many medical devices rely on PFAS and that no existing alternatives can match their unique properties. As a result, the conclusion is that there is currently no justification for restricting their continued use in medical devices.

Some in the industry may see this as the end of the debate, but the conversation is far from over. Forward-thinking, progressive companies worldwide are pressing ahead, investing in materials and processes that reduce environmental impact without compromising performance. The truth is clear: innovation, not regulation, will shape the future of med device. And those bold enough to lead that innovation will define what comes next.

In the years ahead, which will matter more in medical devices — performance, sustainability, or something we haven’t yet imagined?