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FDA says manufacturer failed to comply with medical device reporting related to respirator decontamination

Disinfection of disposable respirators not allowed per Cal/OSHA guidance

October 22, 2020 5442

The manufacturer of a decontamination system used to decontaminate certain N95 respirators for health care personnel received a warning notice last week from the U.S. Food and Drug Administration for “failure to comply with regulatory requirements for medical device reporting.”

Battelle Memorial Institute received an FDA emergency use authorization in late March to use its Critical Care Decontamination System to decontaminate N95 respirators for multiple-user reuse when filtering respirators are in short supply due to COVID-19 pandemic.

Under the EUA’s conditions, Battelle was required to have a process in place to report adverse events related to the system’s use, such as allergic reactions or evidence that a decontaminated respirator is not performing. After requesting and receiving information from Battelle, the FDA concluded that Battelle did not meet the reporting requirement.

The FDA asks health care professionals and consumers to report any adverse events related to devices to the FDA. The FDA maintains a list of decontamination systems that have EUAs to decontaminate certain respirators during the pandemic with fact sheets included for health care personnel.

Disposable respirators cannot be reused during pandemic

Although health care personnel can continue to disinfect used respirators, they should not reuse the respirators during the COVID-19 pandemic according to Cal/OSHA’s interim guidance for health care facilities issued Aug. 6.

“They may be retained for use in the event of a future respirator shortage,” the guidance states. The interim guidance goes on to state that several other optimization strategies to lengthen respirator use are still permitted, including extended use.

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