COLUMBUS, Ohio -- Gov. Mike DeWine on Sunday sharply criticized the U.S. Food and Drug Administration for approving only limited use of a new mask-cleaning technology developed by an Ohio research firm, saying the decision would harm the nation’s fight to protect front-line medical workers and first responders against the coronavirus.

DeWine’s uncharacteristic rebuke of the federal COVID-19 response spurred a quick response, prompting President Donald Trump and U.S. Food and Drug Commissioner Stephen Hahn to call him directly within hours, according to DeWine.

DeWine told reporters Sunday that Hahn had called him just before his impromptu press conference was to have begun.

“He told me this would be cleared up today, he thought we would be able to have what we want,” DeWine said. "And what we want is help for our first responders, what we want is help for our medical personnel who definitely need this.”

DeWine had touted the new technology, developed by Battelle, at a Saturday news conference, saying his administration was pushing the FDA to approve its use in Ohio and three areas hit hard by COVID-19 -- Seattle, New York and Washington D.C.

Battelle leaders said their technology could sterilize up to 160,000 respirator masks for re-use per day in Ohio alone. The firm said Saturday “the first completed system is in transit and will be placed at an undisclosed location in the New York metropolitan area to address that city’s critical shortage of PPE [personal protective equipment] needed by healthcare workers and first responders.”

But the FDA only granted Battelle permission to clean masks at its Columbus headquarters, and only 10,000 per day. The FDA’s limited approval allows for the masks to be sanitized and re-used up to 20 times.

DeWine issued a scathing statement on Sunday morning, calling the decision "nothing short of reckless."

“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," he said. "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.”

In a Saturday letter to Battelle officials, FDA Chief Scientist Denise Hinton outlines protocols for instructing employees how to use the device and reporting the results to the FDA. But she did not explicitly spell out the case for initially limiting its use.

“I have concluded ... that it is reasonable to believe that the known and potential benefits of the authorized Battelle Decontamination System, when used and labeled consistently with the Scope of Authorization of this letter ... outweigh the known and potential risks of such products,” the letter states.

(Scroll down to read the letter, or click here for a PDF)

In a Saturday blog post about its COVID-19 response, the agency said it was “taking every possible action” and “providing maximum regulatory flexibility” to try to address the national shortage of protective equipment for medical workers.

Later Sunday morning, DeWine tweeted that he had spoken with Trump about the issue. Trump said he will “do everything he can to get this approved today," DeWine said on Twitter.

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. https://t.co/iha2F2AXgv — Governor Mike DeWine (@GovMikeDeWine) March 29, 2020

Trump in a tweet early Sunday afternoon urged the FDA to approve Battelle’s devices.

Hope the 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. — Donald J. Trump (@realDonaldTrump) March 29, 2020

Battelle for decades has developed technology used by the military to protect against biological and chemical hazards. It said the new mask-cleaning technology builds off research conducted for the FDA in 2015 that assessed the feasibility of cleaning N95 respirator masks in the event of a PPE shortage resulting from a pandemic.

The technology uses hydrogen peroxide in a cleaning process that takes several hours, according to Battelle officials. They believe it could be used to safely address a shortage of PPE, and have been making plans to distribute the devices nationally, including immediately deploying them in New York City.

DeWine said he had gone to bed Saturday night thinking the technology had been approved for widespread use.

But he said he awoke Sunday morning to learn it was only limited approval.

“Needless to say, I was quite angry,” DeWine said “I picked up the phone and called President Trump. The president called me back. We had a great conversation. He told me that he would do everything he could to make sure this got done today.”

Battelle CEO Lou Von Treer said his staff had been in contact with FDA regulators, explaining to them how the technology works and sharing their internal testing data.

He said their concerns were more about how the technology would be used and scaled up, rather than with the underlying technology itself.

“We’ve been back and forth in dialogue. I think they’re very comfortable with the technology, and it’s just the logistics and making sure they understand exactly how we’re going to use these systems and parsing through those final details," he said.

After his briefing, DeWine tweeted that he’d spoken with New York Gov. Andrew Cuomo, a Democrat, about his conversations with the president and the FDA.

I talked with @NYGovCuomo a short time ago to update him on @Battelle's sterilization technology and our progress with @US_FDA. He was happy to hear that this critical N95 sterilization could soon be happening for frontline workers in NY. We'll update everyone when we hear more. — Governor Mike DeWine (@GovMikeDeWine) March 29, 2020

Read recent Ohio coronavirus coverage:

Machines could sanitize 160,000 masks for reuse each day in Ohio, if approved by FDA

Ohio coronavirus cases surpass 1,000 mark with 19 deaths: Gov. Mike DeWine’s Friday, March 27 briefing

So what is the potential peak of coronavirus cases in Ohio? Sorting out the various projections

Mapping Ohio’s 1,137 coronavirus cases, plus daily trends

Gov. Mike DeWine’s urgent call: Ohio must triple hospital capacity by mid-April for coronavirus peak

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