The FDA gave full approval to Battelle to utilize new surgical mask sterilization technology, which can decontaminate up to 80,000 masks a day per unit.
"I want to thank President Trump for his leadership and Dr. Hahn of the FDA for approving the use of this life-saving technology that Battelle has developed," said Gov. Mike DeWine. "This will not only help Ohio's healthcare workers on the front lines of the COVID-19 crisis, but Battelle will also be helping health care workers in hot spots throughout the country including New York and Washington state."
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The masks are needed in testing and treatment of patients suffering from coronavirus.
Battelle will also send two its critical care decontamination machines to New York, allowing for the sterilization of up 160,000 surgical masks a day for the state.
The company also plans to ship for more machines throughout the country this next week and another 15 machines in the upcoming weeks.
The FDA initially limited Battelle’s approval to 10,000 masks a day, drawing criticism from Gov. Mike DeWine and Lt. Gov. Jon Husted.
“The FDA’s decision to severely limit the use of this life-saving technology is nothing short of reckless,” DeWine said in a statement. “Battelle’s innovative technology has the capability to protect health care 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.”
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Added DeWine: “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.”
For days running, DeWine has publicly pleaded with the FDA to issue an emergency waiver for the use of the new technology that could sterilize up to 160,000 personal protective face masks every day.
At first, after a phone call from the FDA to Lt. Gov. Jon Husted at about 1 a.m. Sunday, Ohio officials thought they had the authorization they needed to fully deploy the Battelle technology.
Later Sunday, however, they learned that, as DeWine put it, “The devil is in the details.” The actual permitted number was far lower — 10,000 daily sterilizations, not 80,000.
“I’ve known the governor for a long time. I don’t know that I have ever seen him more frustrated than he was with this,” Husted said.
DeWine said he spoke with President Trump on the issue Sunday.
“He got it. He understood it,” DeWine recounted. “He said, ‘Look, I’m moving. I’ll get this done.’”
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“It’s not done yet, but I am cautiously optimistic,” the governor said in a hastily called press conference Sunday.
“This needs to get approved today,” Husted said in the press conference with DeWine, referring to the need to go beyond 10,000 daily sterilizations.
Husted said Ohio leaders are emphasizing with the FDA that in the absence of the requisite number of N95 face masks, the Battelle technology is crucial.
“We’ve got to have this because people on the ground are depending on it,” Husted said.
Said DeWine: “We don’t have enough of these masks.”