FDA OKs Battelle mask-sterilization technology


COLUMBUS, Ohio — After a day of pressure from Ohio Gov. Mike DeWine, the U.S. Food and Drug Administration late Sunday rewrote rules to allow full application of a potentially game-changing Battelle technology to sterilize protective masks worn by those treating coronavirus victims.

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

DeWine said Sunday night that he and Lt. Gov. Jon Husted “just had a very productive call” with the Food and Drug Administration. “I anticipate a positive announcement soon. We must do all we can to protect our frontline workers.”

Husted tweeted: “This Ohio-driven solution has the potential to save lives now and in the future across the United States.”

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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.



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