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Jan 25, 2021 7:25am The FDA is reissuing 10 of its earliest authorizations from the past year, limiting each mask processed to a maximum of four decontaminations. (FDA)
The FDA has rolled back its emergency authorizations for N95 respirator decontamination systems, cutting down the number of times the agency said each mask could be safely reused.
During the early stages of the pandemic, when supplies of personal protective equipment and N95 filters were at a minimum, the FDA allowed masks to be reprocessed up to 20 times with certain hardware.
Systems produced by Battelle, Steris, Stryker and Advanced Sterilization Products kill viruses and bacteria by gassing them with hydrogen peroxide vapor in devices ranging from the refrigerator-sized to walk-in shipping containers.