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

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.
The company has two machines — each capable of cleaning 80,000 masks a day — ready to go for Ohio. It also is deploying machines to New York, Seattle and Washington, D.C. That means the new order could allow for up to 400,000 clean masks a day in the short run.
The FDA's original limitation of 10,000 mask sterilizations each day prompted an angry news release from DeWine and telephone and Twitter exchanges between the governor and President Donald Trump.
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.

https://www.usatoday.com/story/news/nation/2020/03/29/coronavirus-fda-eases-restrictions-mask-sterilization-technology/2936670001/

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

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

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