FDA Authorization of STERIS Mask Decontamination System a “Game Changer for Our Heroes on the Front Lines”
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today released the following statement from President and CEO Scott Whitaker on STERIS’s Emergency Use Authorization (EUA) from FDA for certain V-PRO® Low Temperature Sterilization Systems to allow health care providers to decontaminate N95 respirators on site:
“I agree with Commissioner Hahn: The ability to quickly decontaminate protective masks – and starting today, starting now, for every health care facility with these systems on site – truly is a game changer for our heroes on the front lines treating patients with COVID-19. STERIS’s fast, innovative work, in partnership with 3M, is yet another example of the medical technology community mobilizing to save lives. We appreciate the FDA’s quick work to authorize this leap forward in our fight against the coronavirus.”
According to the FDA, up to 750,000 masks across the country could be decontaminated daily under this new authorization, and each mask can be decontaminated up to ten times before needing to be replaced.
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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.