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FDA limits Battelle’s PPE mask sterilizing technology to 10k a day

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(Nexstar DC photo)

COLUMBUS, O.H. (WCMH) — Ohio Governor Mike DeWine, along with Lt. Governor Jon Husted, have released a statement expressing frustration after they say the U.S. Food and Drug Administration decided to limit the use of new technology to sterilize desperately-needed surgical masks. 

In a statement released Sunday morning, DeWine and Husted announced the FDA has authorized Columbus-based Battelle to sterilize only 10,000 surgical masks in Ohio each day, despite their ability to sterilize up to 160,000 masks per day in Ohio alone.  

The authorization of 10,000 masks per day is limited to Battelle’s Columbus headquarters and prevents Battelle from sending its groundbreaking technology to other states such Washington and New York, as well as Washington D.C. and the Virginia/Maryland areas, according to the release. 

“The FDA’s decision to severely limit the use of this life-saving technology is nothing short of reckless,” said DeWine in the statement. “Battelle’s innovative technology has the capability to protect healthcare professionals and first responders in Ohio and across the country, but in this time of crisis, the FDA has decided not to support those who are risking their lives to save others. This is a matter of life and death. I am not only disappointed by this development, but I’m also stunned that the FDA would decline to do all it can to protect this country’s frontline workers in this serious time of need.” 

DeWine announced on Twitter that he had talked to President Donald Trump about the situation.

“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,” the tweet reads.

The FDA issued the following statement Sunday afternoon:

FDA issued an Emergency Use Authorization (EUA) on March 28th to Battelle Memorial Institute for its Battelle Decontamination System for use in decontaminating compatible single-use N95 respirators so they can be reused by health care personnel. The EUA issued, as requested by Battelle, currently allows for Battelle to decontaminate up to 10,000 N95 respirators per day. We understand Battelle now would like to expand that capacity, beyond their Ohio facility, and we are working with them, and the state of Ohio, expeditiously so they can scale up their N95 decontamination services to other locations outside of Ohio. This EUA is an important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by medical professionals on the front lines of the COVID-19 pandemic. We will continue to exercise regulatory flexibility to increase the supply of certain essential medical devices needed for health care personnel to protect against COVID-19 and to provide the best care to patients with COVID-19.

FDA SPOKESPERSON

DeWine made a public appeal to the FDA Saturday, during his daily news conference,  to approve the process as soon as possible. 

“Please, please, give us the approval to use these,” he said. “We have nurses, we have doctors, we have people working in nursing homes who need the masks.” 

“In addition to offering this technology in Ohio, Battelle had intended to send one machine to New York City and one to Stony Brook, New York, which would have allowed for the sterilization of up to 160,000 surgical masks for New York’s healthcare workers each day. Machines would have also been dispatched to the state of Washington and the Washington D.C. metro area,” the statement also adds.  

Battelle had planned to ship four more units elsewhere in the United States next week and 15 additional machines in the coming weeks.  

DeWine and Husted said they’ll continue fight for increased use of the technology. 

To read the full response click here.

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