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

Officials are scrambling for N95 masks and other protective equipment for health care workers as the number of COVID-19 cases is expected to spike.

3/30/2020 6:28:00 AM

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.

Officials are scrambling for N95 masks and other protective equipment for health care workers as the number of COVID-19 cases is expected to spike.

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.”

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Husted tweeted: “This Ohio-driven solution has the potential to save lives now and in the future across the United States.”‘Life may change for us all’:How we respond to the coronavirus crisis will be defining, historians sayThen 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.

New York is at war with the coronavirus:Expect the same across the US, experts warn.DeWine talked to Trump later in the morning and said the president was willing to help.“I have just talked with @realDonaldTrump about this issue, and we had a good conversation. He understands the problem and says he will do everything he can to get this approved today. Thank you, @POTUS,” DeWine tweeted.

Four minutes earlier, Trump had tweeted an article about the Battelle invention, commenting, “Highly recommended by Governor @MikeDeWine of Ohio. @FDA must move quickly!”Then, Trump tweeted, “Hope FDA can approve Mask Sterilization equipment ASAP. As per Governor @MikeDeWine, there is a company in Ohio, @Battelle, which has equipment that can sterilize masks quickly.”

Read more: USA TODAY »

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? Made in China, Virus the World

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FDA eases restrictions on mask-sterilizing technology amid coronavirus shortagesOfficials are scrambling for the N95 masks and other protective equipment for health care workers as the number of COVID-19 cases is expected to spike.

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