FDA Commissioner Warns of Impacts From Sterilization Facility Closures
Acting FDA Commissioner Sharpless urged medical device manufacturers that use ethylene oxide facilities to assess their inventory for potential impacts of sterilization facility closures on their product distribution.
The call comes as Sterigenics facilities in Atlanta, Ga. and Willowbrook, Illinois are currently closed, and the company has announced that it will not reopen the Willowbrook facility.
Sharpless said the agency is coordinating with devicemakers and other stakeholders on impacts to medical device availability, as well as communicating with Sterigenics and medical device companies that may be affected.
He urged healthcare facilities to assess any medical supplies that undergo contract terminal sterilization via ethylene oxide prior to shipping and encouraged them to reach out to the agency for help in identifying substitute devices.
EC Certifies First Notified Body Under EU IVDR
The European Commission designated Germany-based Dekra Certification as the first notified body under the EU’s In Vitro Diagnostic Regulation, which becomes effective in May 2022.
Dekra was also designated as a notified body under the EU Medical Devices Regulation, which becomes effective in May 2020.
The commission said it expects to have 20 notified bodies in place for both the MDR and the IVDR by the end of 2019, but the industry has been skeptical that it will reach that number.
MedTech Europe urged member states to “acknowledge that we are not on track,” and to prepare for the lack of notified bodies.
The industry group flagged the need for more notified bodies for certification of new products, recertification, Eudamed, quality guidance, scientific bodies and harmonized standards.