Coronavirus shortage: FDA approves process to decontaminate 4 million N95 masks per day

Monday, April 13, 2020

FDA clears process to sterilize millions of N95 masks per day

The U.S. Food and Drug Administration issued an emergency use authorization that has the potential to sterilize approximately 4 million N95 masks per day for the reuse by health care workers in the front lines of the COVID-19 pandemic.

SAN FRANCISCO (KGO) -- The U.S. Food and Drug Administration issued an emergency use authorization (EUA) that has the potential to sterilize approximately 4 million N95 masks per day for the reuse by health care workers in the front lines of the novel coronavirus pandemic.

"Our nation's health care workers are among the many heroes of this pandemic and we need to do everything we can to increase the availability of the critical medical devices they need, like N95 respirators," said FDA Commissioner Stephen M. Hahn, M.D. "FDA staff continue to work around the clock, across government and with the private sector to find solutions. This authorization will help provide access to millions of respirators so our health care workers on the front lines can be better protected and provide the best care to patients with COVID-19."

The FDA granted Advanced Sterilization Products the EUA for the STERRAD Sterilization Cycles which uses vaporized hydrogen peroxide gas plasma sterilization to decontaminate the respirators. There are approximately 6,300 hospitals across the U.S. with the STERRAD Cycles and each load takes from 24 to 55 minutes and can reprocess 480 per day, officials say.

For more information, see the FDA's website here.

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