FDA lifts restrictions on Ohio-based Battelle's mask-sterilizing technology amid coronavirus shortages

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Ohio Gov. Mike DeWine said federal officials have promised to ease restrictions on a technology to clean and reuse the masks deemed the safest for healthcare workers and first responders in the coronavirus outbreak.

that upgrading its emergency use authorization from partial to full “is appropriate to protect the public health or safety.”

Then the FDA issued a new waiver to Battelle, a Columbus-based non-profit. It said, “Battelle is authorized to decontaminate up to 10,000 compatible N95 respirators per chamber load,” in its new machine that decontaminates the safest masks against coronavirus and can allow 20 re-uses of the devices, which are in perilously short supply.

DeWine issued an angry news release in the morning calling the FDA “reckless” for dramatically limiting the number of cleaned masks. It was a sharp rebuke from a Republican governor who until now has refrained from criticizing the Trump administration’s handling of the COVID-19 outbreak.DeWine talked to Trump later in the morning and said the president was willing to help.

 

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Question: does this fall under a current GAO contract with Battelle, or is this a new contract? Just wondering, as they lost a $160M contract to Laulima Govt. Solutions for the NIAID BLS-4 labs at Ft. Detrick? There were two breaches of the lab reported in Nov. 2019?

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