Coronavirus mask decontamination process approved by FDA as workers face shortage
Decontamination process would allow N95 masks to be cleaned using vaporized hydrogen peroxide gas
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The U.S. Food and Drug Administration approved a decontamination process that could clean up to 4 million medical masks for frontline health care workers per day, according to the agency.
As doctors and nurses face ongoing shortages for personal protective equipment while treating coronavirus patients, the FDA has provided an emergency use authorization (EUA) for a decontamination process that would allow N95 masks, originally intended for single-use, to be cleaned using vaporized hydrogen peroxide gas.
As police and fire departments across the country face personnel shortages due to the spread of the new coronavirus, masks and other protective gear are being used to keep officers and firefighters safe and healthy. (AP Photo/Ted S. Warren)
The FDA is allowing the Irvine, Calif.-based company Advanced Sterilization Products to carry out a decontamination process using vaporized hydrogen peroxide gas to clean masks. The company uses sterilization machines called STERRAD, which uses hydrogen peroxide gas plasma sterilization.
The machines are already in use in around 6,300 hospitals, according to the FDA, and each can clean 480 respirators per day.
The sterilization system will help combat the shortage of vital face masks used by doctors, nurses and health care workers to protect themselves from exposure to COVID-19.
"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," FDA Commissioner Dr. Stephen M. Hahn said in a statement.
N95 respiration masks help protect health care workers from the spread of COVID-19. (REUTERS/Nicholas Pfosi)
"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."
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The FDA approved a similar system to decontaminate N95 masks called Battelle's vaporized hydrogen peroxide process. And Duke University was an early adopter in urging this process to be used to decontaminate equipment.
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Some hospitals are also using ultraviolet light to decontaminate masks so they can be reused. The University of Nebraska Medical Center started experimenting with UV-light last month to decontaminate masks, hanging used masks up in rooms with two ultraviolet light towers. Once they're decontaminated, masks are returned to their original owners, enabling health care workers to wear them for up to a week longer.
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Imports of vital medical supplies were rapidly decreasing due to factory closures in China, where manufacturers were required to sell all or part of their inventory internally instead of exporting them to other countries, The Associated Press reported last week.
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