FDA Sets New Restrictions For Authorized N95 Decontamination Systems
After reviewing real-world data, the US agency says the decontamination systems should only be used for compatible facemasks and should not be used to clean a mask more than four times.
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The US agency has pulled the emergency use authorization for Battelle’s face mask decontamination system after a request from the company, which has also closed sites where masks were being decontaminated.
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Battelle Memorial Institute, an N95 respirator decontamination system maker, has been back-and-forth with regulators about its Medical Device Reporting protocols, which the US FDA says is lacking. Battelle was granted an emergency use authorization by the agency for its CCDS Critical Care Decontamination System to decontaminate N95 respirators back in March.