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FDA OKs system to decontaminate, reuse face masks for coronavirus

By
Don Jacobson
St. Louis Fire Department paramedic Andrew Beasley wears a mask, gloves and a gown as he disinfects the back of an ambulance with a bleach mix, after delivering a patient to the Emergency Department at Barnes-Jewish Hospital in St. Louis on March 16.  Photo by Bill Greenblatt/UPI
St. Louis Fire Department paramedic Andrew Beasley wears a mask, gloves and a gown as he disinfects the back of an ambulance with a bleach mix, after delivering a patient to the Emergency Department at Barnes-Jewish Hospital in St. Louis on March 16.  Photo by Bill Greenblatt/UPI | License Photo

March 30 (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.

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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.

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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.

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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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