FDA permits limited use of Battelle tech after criticism, DeWine presses for more


By Thomas Gnau - Dayton Daily News, Ohio (TNS)



DeWine

DeWine


The U.S. Food and Drug Administration is allowing limited emergency use of an Ohio-born decontamination system that will let health care workers sterilize and reuse precious N95 respirators.

“Battelle is authorized to decontaminate up to 10,000 compatible N95 respirators per day, consistent with the data provided to FDA,” said an FDA letter Saturday to Jeff Rose, vice president of government relations at Battelle.

Battelle and Ohio leaders want to go well beyond that, to 80,000 mask sterilizations a day, equipping health care providers on the front line of the fight against COVID-19.

“It’s not done yet, but I am cautiously optimistic,” Ohio Gov. Mike DeWine said in a press conference Sunday.

DeWine said he spoke with President Trump on the issue.

“He got it. He understood it,” DeWine said. “He said, ‘Look, I’m moving. I’ll get this done.’”

Dr. Stephen Hahn, FDA commissioner, issued the news in a tweet Sunday afternoon.

“FDA issued an Emergency Use Authorization (EUA) to @Battelle for its Battelle CCDS Critical Care Decontamination System for use in decontaminating compatible single-use N95 respirators so they can be reused by health care personnel during #COVID19,” Hahn tweeted.

N95 respirators are respiratory protective face masks.

Earlier, Ohio Gov. Mike DeWine blasted the U.S. Food and Drug Administration on that agency limiting the use of an Ohio-born technology to sterilize widely needed surgical masks.

The U.S. Food and Drug Administration denied Columbus-based Battelle permission to sterilize a far greater number of face masks a day, capping the company to just 10,000 daily sterilizations of the masks.

The ruling also blocks Battelle from sending its technology to other metro areas, a release from DeWine’s office said Sunday morning.

“The FDA’s decision to severely limit the use of this life-saving technology is nothing short of reckless,” DeWine 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.”

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 two 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.

The technology was developed by Columbus-based Battelle and could be used elsewhere.

In addition to offering this technology in Ohio, Battelle had intended to send one machine to New York City and another to Stony Brook, N.Y, which would have allowed for the sterilization of up to 160,000 surgical masks for New York’s health care workers each day, DeWine’s office said in a release.

Machines would have also been dispatched to the state of Washington and Washington D.C., the governor said.

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

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https://www.limaohio.com/wp-content/uploads/sites/54/2020/03/web1_DeWine-9.jpgDeWine

By Thomas Gnau

Dayton Daily News, Ohio (TNS)

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