The FDA had previously issued EUAs for decontamination systems to sterilize masks up to 10 times to combat shortages amidst the COVID-19 pandemic, but many had raised concerns about effectiveness, and with its reissued EUAs the agency now says four times should be the max, reports Medical Design & Outsourcing.
The FDA announced that it has reissued EUAs for nine of those decontamination systems to reprocess each compatible N95 respirator up to four times only. Renewed EUAs went to Advanced Sterilization Products, Battelle, Duke University, Michigan State University, Sterilucent, Steris (two EUAs), Stryker (two EUAs), and Technical Safety Services.
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