Tuttlingen – "A differentiated view must be taken against the blanket ban thinking," says Managing Director Julia Steckeler about the new position paper of MedicalMountains GmbH on the restriction process for per- and polyfluorinated alkyl substances (PFAS) in the EU: Should the present draft of the European Chemicals Agency remain unchanged go through, serious consequences for patient care and the entire industrial landscape can be expected.
In particular, fluoropolymers and fluoroelastomers are indispensable in medical technology. They give catheters and guide wires excellent gliding properties, have paved the way for electrosurgery and minimally invasive surgery, can be found in dialysis machines, cardiac pacemakers as well as anesthesia and ventilators, and are essential for high technology such as magnetic resonance imaging or computed tomography. Conversely, this means: "Without the polymers, interventions can only be made more difficult or in many cases no longer possible at all," says Julia Steckeler, "the wheel of medical technology innovation is turned back by decades." An exception of fluoropolymers from the current process is the only one sensible solution to ensure the current level of patient care and safety and to expand it further in the future.
At the end of March, the European Chemicals Agency (ECHA) published the dossier on the EU-wide restriction of PFAS. They have come under criticism because they cannot be broken down under natural conditions and can accumulate in nature. In the past, substances of concern were regulated individually, but now the entire group of around 10,000 substances is to be banned. According to Julia Steckeler, there can no longer be any question of a clean risk assessment. “Fluoropolymers are safe to use. They are not bioaccumulative and have no negative effects on health," says Julia Steckeler, referring to the content of the position paper. "In it, we use scientific sources to explain that they are chemically and physically fundamentally different from those questionable compounds that should rightly be withdrawn from the market."
The position paper also describes the consequences for the economy. "The medical technology industry is already under a lot of pressure," reminds Julia Steckeler. "A blanket ban on PFAS would result in the next big wave of product discontinuations and plant closures." And if, in individual cases, they do, the costs for the approval of new or modified products for small and medium-sized companies can no longer be borne. Quite apart from the fact that the entire EU industrial location is in danger. “The high-performance polymers are also required for the production of semiconductor technology and green hydrogen. The European Chips Act and the Green Deal would be doomed to failure,” the MedicalMountains managing director points out that the various efforts within the EU are hardly or not at all coordinated. "Instead of creating more resilience, there is a risk that dependence on China will continue to grow," warns Julia Steckeler.
The ECHA consultation process is still running until September 25th. In this course, the draft can be commented on and supplemented in specific points. MedicalMountains GmbH is also involved in this. "In close cooperation with companies and associations, we throw all arguments into the balance so that reason in the sense of patient protection and patient safety wins in the end," hopes Julia Steckeler.
The document "Positions of MedicalMountains GmbH on the proposal for a restriction of per- and polyfluorinated alkyl substances (PFAS)" can be accessed free of charge in the online shop under this link.
