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FDA Says 4M N95 Masks Could be Reused Thanks to Emergency Order

Analysis  |  By Brian Ward  
   April 15, 2020

The process has N95 masks placed in a room, sprayed with vaporized hydrogen peroxide using a special machine, and left to dry.

Editor’s note: This article was originally published in the newsletter Briefings on Accreditation & Quality. Briefings on Accreditation & Quality is published through the HCPro Accreditation & Quality Compliance Center

The FDA has issued two emergency use authorization (EUA) for sterilizing and reprocessing N95 masks, once in March and once in April. The agency says this “has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for reuse by health care workers in hospital settings.”

“Authorizing this sterilization system will make it easier for hospitals to ensure that heroic healthcare workers on the frontlines have the protection they need,” wrote HHS Secretary Alex Azar. “Thanks to rapid work by the men and women of the FDA and President Trump’s vision for an all-of-America response, innovators are giving our healthcare warriors new tools nearly every day to fight the COVID-19 pandemic.”

The process has N95 masks placed in a room, sprayed with vaporized hydrogen peroxide using a special machine, and left to dry. A mask can be reprocessed up to 10 times for single-user reuse. Studies have demonstrated that this method:

  • Decontaminates the mask material
  • Doesn’t degrade the mask material’s ability to filter particulates 
  • Doesn’t affect mask fit
  • Doesn’t create any toxic byproducts

EUAs were issued to Battelle Memorial Institute and STERIS. The latter sells the hydrogen peroxide sterilizing equipment, with units 6,300 healthcare facilities equipped STERIS decontamination units. Depending on the unit, it can take between 24 and 55 minutes per reprocessed mask, with a single unit reprocessing about 480 respirators daily.

Battelle Memorial is a non-profit based out of Ohio, and claims its Battelle CCDS Critical Care Decontamination System™ can decontaminate over 80,000 masks per day.

Brian Ward is an associate editor for HCPro who writes about hospital accreditation and patient safety.

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