FDA Allows Ohio Company to Make Unlimited Use of Face Mask Sterilizer After Trump, DeWine Intervene


Ohio Gov. Mike DeWine called an emergency press conference Sunday to express his “deep disappointment” with the Food and Drug Administration for limiting the use of a new technology to sterilize face masks.

DeWine announced Saturday that he had asked the FDA to issue an emergency waiver to Battelle Memorial Institute, a Columbus-based company, for the use of its new technology that could sterilize up to 160,000 protective face masks per day in Ohio. The “Battelle Decontamination System” was developed to help address the nation’s shortage of N95 respirator masks.

“Battelle has had a real breakthrough which would allow surgical masks to be reused, and as soon as the FDA approves the use of this technology, the sterilization can start,” DeWine said. “I’m appealing to the FDA to please give us approval. Ohio innovators have a solution to our problem, and all that stands in the way is FDA approval. This is a matter of life and death.”

But the FDA said in a press release that it had authorized Battelle to sterilize only 10,000 surgical masks in Ohio each day. The use of the technology would have been limited to Battelle’s Columbus headquarters and prevented the company from sending its technology to other states.

“The FDA’s decision to severely limit the use of this life-saving technology is 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,” DeWine said in response. “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 front line workers in this serious time of need.”

DeWine said Battelle planned to send two of its new machines to New York, which would have allowed for the sterilization of up to 160,000 face masks for the state’s health care workers each day. The company also planned to dispatch its machines to Washington state and the Washington, D.C. metro area.

The governor called a Sunday press conference to discuss the FDA’s limited approval of the decontamination device. DeWine said the company has developed a machine that can sterilize 80,000 used masks per day, despite his earlier claims that the machine could sterilize up to 160,000 masks in a day.

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

The president mentioned the new device on Twitter Sunday morning and said the “FDA must move quickly.”

“Hope the FDA can approve mask sterilization equipment ASAP,” Trump added. “As per Governor Mike DeWine, there is a company in Ohio, Battelle, which has equipment that can sterilize masks quickly.”

In another twist, the FDA announced Sunday night that it had issued a new emergency use authorization that allows Battelle to decontaminate 10,000 compatible N95 respirator masks “per chamber load.” Under the new authorization, the number of facilities that can use the new technology and the number of masks that can be cleaned is unlimited.

“Battelle shall provide FDA, in advance of establishing satellite facilities where Battelle will perform decontamination using the Battelle Decontamination System, confirmation that all chambers, critical parameters, logistics, processes, containment systems, and labeling are identical and in place at all satellite facilities,” states the new emergency use authorization.

A load of 10,000 N95 respirators can be cleaned in one chamber and three loads can be done per day, which equals 30,000 masks per chamber each day. So, if a site has multiple chambers cleaning 30,000 masks per day, the number goes up indefinitely.

“This is an example of everyone working quickly to help find a solution. FDA staff have been working around the clock to help mitigate this pandemic as swiftly as possible. After receiving Battelle’s request today, we turned it around in a matter of hours and issued a new authorization allowing them to ramp up their capability to decontaminate more respirators,” FDA Commissioner Stephen Hahn said in a statement provided to The Ohio Star.

“FDA is committed to working across government and with the private sector to find solutions fast. We are willing to be flexible and adapt to this pandemic, so that we can get essential medical devices to those in need to protect against COVID-19.”

Gov. DeWine thanked the FDA on Twitter Sunday night for granting Battelle full approval to make use of its device.

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Anthony Gockowski is managing editor of The Minnesota Sun and The Ohio Star. Follow Anthony on Twitter. Email tips to [email protected]







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