Following the online panel discussion organized by wvib entitled “The EU bans PFAS – what now?”, the Badische Zeitung newspaper took up the topic and examined it in a recent article. Katharina Meyer, editor in the “Science and Medicine” department, published a nuanced article on the possible regulation under the title “Small and medium-sized businesses sound the alarm over PFAS ban.” From our point of view, this is an important impetus for a broader social debate – because that is precisely what has been largely lacking so far.
We support regulation—but it must be practical and responsible.
Sutter is not opposed to PFAS regulation. What we are calling for is a differentiated approach that serves the goal of protecting the environment and human health without jeopardizing essential technologies for patient care.
The European Chemicals Agency (ECHA) is planning a far-reaching restriction on nearly 10,000 PFAS compounds. While pharmaceuticals, pesticides, and biocidal products have been exempted, the proposal still affects highly regulated medical devices – even though they also serve to protect human health and life. This is not only disproportionate, but also ignores the real risks and technical dependencies in medical technology.
Our products are not mass consumer goods. They are manufactured in small quantities for highly specialized procedures and consist of materials such as PTFE, ECTFE, and PVDF, which cannot be easily replaced due to their chemical stability, biocompatibility, and insulating properties. It is precisely because these materials are so inert and durable that they meet the highest safety and functional requirements in the operating room.
What do we want? An objective assessment.
One that does not equate medical devices with Teflon pans or outdoor jackets. And one that does not jeopardize supply security and patient protection with unrealistic deadlines and a lack of alternatives.
Sutter participated in the public consultation process—on its own behalf and through the industry association SPECTARIS. Whether our arguments will be heard remains to be seen. One thing is clear: without practical exceptions, many specialized medtech companies face an uncertain future.
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