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FDA consents to expand approval for N95 mask disinfecting technology

Posted at 10:56 PM, Mar 29, 2020
and last updated 2020-03-29 23:45:28-04

The FDA, after appeals from Governor Mike DeWine and Lt. Gov. Jon Husted, has approved Columbus-based company Battelle's new technology to disinfect N95 masks, conceding to the company's request for permission to clean up to 80,000 masks a day for healthcare professionals on the front lines of the COVID-19 pandemic.

Early Sunday morning, the FDA had given Battelle permission to use the technology, but only to clean 10,000 masks per machine, per day. By contrast, the company was requesting clearance to clean 80,000 masks per machine, per day.

During a heated press conference Sunday afternoon, Governor Mike DeWine called the Food and Drug Administration "reckless," and asked the agency to allow Battelle Labs to move forward with mask-sterilizing technology.

"We have been waiting and waiting and waiting," said DeWine.

DeWine said his administration has been working with Columbus-based Battelle and the FDA for several days to try to obtain approval for technology that can sterilize the N95 surgical masks on a large scale. The N95 masks are crucial for specialized health care and those on the front lines working to combat COVID-19. Currently, officials said there are not enough of these masks available for healthcare providers to get through this pandemic safely.

"This is really important," DeWine said. "The reason it's really important is we have to protect the people who are on the front line."

Battelle developed the technology years ago, but the COVID-19 pandemic has forced the company to ramp up the devices to disinfect masks on a much larger scale.

The company has two of these mask-cleaning devices in Ohio, one in the New York City area and one ready to send to Washington ready to be put to use right away, with more devices in the works.

"The devil was in the details," said Husted. "It was only allowed to occur on a limited basis. That's just not good enough."

DeWine said he took his case straight to President Donald Trump, saying with so many lives hanging in the balance, that limited approval the FDA was initially offering was not enough.

"It's not going to solve every single problem," said DeWine. "We know that. It's not going to stop the surge coming at us. But it is going to help."

According to a press release from DeWine's office, Battelle plans to ship four additional cleaning units elsewhere in the United States in the coming week, with 15 more machines coming after that.