Company that decontaminates N95 masks receives FDA warning

The manufacturer of a system used to decontaminate certain N95 respirators for healthcare personnel received an FDA warning Oct. 7 for failing to comply with regulatory requirements for medical device reporting.

In March, Columbus, Ohio-based Battelle Memorial Institute received emergency use authorization from the FDA to use its decontamination system for N95 respirators reused by multiple individuals.

The FDA concluded that Battelle didn't have a reporting process for adverse events related to the system's use, such as allergic reactions or evidence that a decontaminated respirator isn't functioning properly.

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