Tuttlingen - The European Chemicals Agency ECHA has published the proposal for a restriction of per- and polyfluorinated alkyl substances, better known as PFAS. The content affects medical technology to a considerable, sometimes fundamental extent: As part of the Med Alliance BW, MedicalMountains GmbH invites you to a kick-off meeting on May 11th to jointly develop statements for the ongoing consultation process on the basis of a draft.
Interested groups can comment on this ECHA dossier until September 25th. From the point of view of medical technology, this is also urgently required. "If the current content stays the same, a number of proven medical devices in which PFAS are used will no longer be allowed to be placed on the market in the near future," summarize the MedicalMountains managing directors Yvonne Glienke and Julia Steckeler. Since in many cases there are no alternatives in sight, this would have serious effects on minimally invasive and electrosurgery, among other things - and ultimately on patient care. One must realize that the spectrum of available instruments and devices is threatened to become even scarcer than it already is. "In the course of the MDR, many products and entire product lines have already been withdrawn from the market. The next big wave is building up with a comprehensive PFAS ban,” predict the managing directors.
It is undoubtedly right to reduce the discharge into the environment and, above all, to take action against harmful PFAS. “However, the restriction covers everything across the board, more than 10,000 substances. These include those that can be used without hesitation and are at the same time essential for medical technology.” There are more sensible approaches, for example to reduce emissions in the production of PFAS or to set up a recycling system. Exactly on these and other topics, the exchange with medical device manufacturers is to be sought on May 11th. The online event will also look at how individual companies can bring their concerns into the consultation process - but also the MedicalMountains cluster as a whole. "We would like to work together to give voices from the industry even more weight," says Yvonne Glienke. MedicalMountains GmbH has drafted a new position paper for this. On this basis, it can be further specified where PFAS contribute to patient safety, what the consequences of a blanket ban would be, what other solutions there are - in order to then bring these points into the consultation process. The Med Alliance BW is very well suited as a platform for exchange, explains Julia Steckeler. “On the one hand, because we focus here on regulatory and transformative challenges for medical technology. PFAS is definitely one of them.” On the other hand, because working groups such as “Material Compliance” have been dealing with the topic for a long time. The core elements of the Med Alliance BW are "to engage in dialogue, to share knowledge, to support one another in order to make better, safer and faster progress together," says Julia Steckeler. And that is exactly what one hopes for when it comes to PFAS and implementation issues that go beyond the statement.
Further information and registration for the kick-off event on PFAS statements at https://medicalmountains.de/pfas_konsultation.
