Battelle Decontamination System Gets EUA To Fight Respirator Shortage
The US FDA has issued an emergency use authorization for a Battelle decontamination system to clean N95 masks, which are currently facing a shortage due to the COVID-19 pandemic. The company says it can clean up to 80,000 respirator masks a day from participating health care providers.
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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.
The US agency says it’s no longer going to update its list of certain imported respirators that are allowed on the market under an emergency use authorization for health care workers, or accept new applications for the face masks.
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.