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5/29/2023
Regulation
News
Medical technology associations sound the alarm on PFAS
In a joint letter to the Federal Ministry of Health (BMG), the two medical technology associations BVMed and SPECTARIS have warned of the devastating effects of a universal PFAS ban on patient care with vital medical devices.
The EU Commission is planning a universal ban on around 10,000 perfluoroalkyl and polyfluoroalkyl substances (PFAS) in a sub-legislative regulation, many of which have so far been indispensable and without alternative. The EU Council and the EU Parliament have been involved far too late, criticise BVMed Managing Director Marc-Pierre Möll and SPECTARIS Managing Director Jörg Mayer. They appeal to German health policy-makers to "take an urgent look" at the Brussels initiative, to intervene in the procedure, and to prevent blanket regulations of entire groups of substances.
The draft of a comprehensive PFAS restriction was submitted in January 2023 by the European Chemicals Agency ECHA in the so-called committee procedure under the REACH Regulation. BVMed and SPECTARIS strictly reject the broad regulation of entire substance groups regardless of their proven risk. "This is because the technical property of PFASs in medical devices becomes their political undoing precisely because of which they are used: their durability and resistance on and in the human body," the joint letter to the BMG states.
PFAS are high-performance materials for medical technology, which have made decisive medical-technical advances of the last decades possible in the first place. "Medical devices such as incubators for newborns, heart-lung machines or implants such as pacemakers, stents or joints, but also products with blood contact or packaging for medical devices placed on the market under sterile conditions can then no longer be manufactured and used - and this after a very short transition period," warn the two medical technology associations.
From the point of view of BVMed and SPECTARIS, it is important that the consultation procedure of ECHA, which is already underway, is not merely observed and waited for in the style of an ordinary administrative act. "There is an urgent need for political action, because negative location decisions are already being made in view of the uncertain outcome of the regulation," say Möll and Mayer. Their urgent appeal: "A phase-out of PFAS would have a massive impact on patient: internal safety, the innovative capacity of medical technology, and ultimately also on important future initiatives of the European Union. Policymakers must act quickly now."
The draft of a comprehensive PFAS restriction was submitted in January 2023 by the European Chemicals Agency ECHA in the so-called committee procedure under the REACH Regulation. BVMed and SPECTARIS strictly reject the broad regulation of entire substance groups regardless of their proven risk. "This is because the technical property of PFASs in medical devices becomes their political undoing precisely because of which they are used: their durability and resistance on and in the human body," the joint letter to the BMG states.
PFAS are high-performance materials for medical technology, which have made decisive medical-technical advances of the last decades possible in the first place. "Medical devices such as incubators for newborns, heart-lung machines or implants such as pacemakers, stents or joints, but also products with blood contact or packaging for medical devices placed on the market under sterile conditions can then no longer be manufactured and used - and this after a very short transition period," warn the two medical technology associations.
From the point of view of BVMed and SPECTARIS, it is important that the consultation procedure of ECHA, which is already underway, is not merely observed and waited for in the style of an ordinary administrative act. "There is an urgent need for political action, because negative location decisions are already being made in view of the uncertain outcome of the regulation," say Möll and Mayer. Their urgent appeal: "A phase-out of PFAS would have a massive impact on patient: internal safety, the innovative capacity of medical technology, and ultimately also on important future initiatives of the European Union. Policymakers must act quickly now."
