FDA Issues Emergency Approval For Mask Decontamination Process

The Food and Drug Administration has issued an emergency use authorization for a decontamination process that could sterilize up to 4 million N95 respirators per day using a vaporized hydrogen peroxide gas, TechCrunch reports.

Advanced Sterilization Products’ STERRAD series of sterilization machines will allow for reusing the N95 masks, which are designed for single-use. Just under 10,000 of the machines are currently in use in the U.S., with each one able to sterilize about 480 masks per day. A similar system from Battelle was previously approved by the FDA at the end of March, but can only decontaminate 80,000 masks per day at full capacity.

“All ASP STERRAD Sterilization Systems and disinfectant solutions have been tested against enveloped viruses, the family of viruses that includes coronavirus, and have been demonstrated to be efficacious against those viruses,” the company says in a fact sheet about the machines.

ASP notes that the machines have not been fully FDA-approved, only for emergency use, but says “It is reasonable to believe that the STERRAD Sterilization Systems may be effective at preventing healthcare personnel exposure to pathogenic airborne particulates during periods of insufficient respirator supply during the COVID-19 pandemic by decontaminating, for a maximum of 2 decontamination cycles per respirator, compatible N95 or N95-equivalent respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms.”

The emergency use authorization lasts for the duration of the coronavirus public health emergency, or until revoked or terminated by the FDA.

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