FDA Approves New Decontamination System for Face Masks

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Photo: Bill Greenblatt/UPI


The U.S. Food and Drug Administration has approved a new decontamination system that enables health providers to reuse industrial face masks that have become scarce during the coronavirus outbreak.

The FDA on Sunday issued an emergency-use authorization under which the Battelle Decontamination System, built by the Battelle Memorial Institute of Columbus, will be sent to critical facilities around the United States.

Battelle says the system is capable of decontaminating 80,000 N95 respirator masks each day, which would provide relief to front-line healthcare providers who are seeing severe shortages of personal protection equipment.

The FDA also did an about-face on an earlier stance limiting the number of masks that can be decontaminated each day, following complaints from Ohio Gov. Mike DeWine.

The agency approved a plan over the weekend allowing Batelle to sterilize only 10,000 masks per day, but DeWine said the sterilization was only allowed to occur on a limited basis.

"That's just not good enough, he tweeted.

DeWine later said he spoke with President Donald Trump and the FDA lifted the limit a short time later.

Also Sunday, the FDA issued an emergency-use authorization for a pair of anti-malaria drugs to treat COVID-19. The authorization will allow 30 million doses hydroxychloroquine sulfate and chloroquine phosphate products donated by pharma giants Sandoz/Novartis and Bayer Pharmaceutical to be developed for possible treatment of the coronavirus disease.

Although the anti-malarial drugs have not yet been shown to be effective against COVID-19 in clinical trials, anecdotal evidence exists to show that they could be.

FDA emergency-use authorizations enable new products or new uses for existing drugs without clinical trials if it determines the benefits outweigh the known risks, when there are no alternatives.

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