FDA lifts restrictions on Ohio-based Battelle's mask-sterilizing technology amid coronavirus shortages

COLUMBUS, Ohio – After a day of pressure from Ohio Gov. Mike DeWine, the U.S. Food and Drug Administration late Sunday rewrote rules to allow full application of a potentially game-changing Battelle technology to sterilize protective masks worn by those treating coronavirus victims.

The agency ruled that upgrading its emergency use authorization from partial to full “is appropriate to protect the public health or safety.”

DeWine said Sunday night that he and Lt. Gov. Jon Husted “just had a very productive call” with the Food and Drug Administration. “I anticipate a positive announcement soon. We must do all we can to protect our front-line workers.”

Husted tweeted: “This Ohio-driven solution has the potential to save lives now and in the future across the United States.”

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Then the FDA issued a new waiver to Battelle, a Columbus-based non-profit. It said, “Battelle is authorized to decontaminate up to 10,000 compatible N95 respirators per chamber load” in its new machine that decontaminates the safest masks against coronavirus and can allow 20 reuses of the devices, which are in perilously short supply.

The company has two machines – each capable of cleaning 80,000 masks a day – ready to go for Ohio. It also is deploying machines to New York, Seattle and Washington, D.C. That means the new order could allow for up to 400,000 clean masks a day in the short run.

The FDA's original limitation of 10,000 mask sterilizations each day prompted an angry news release from DeWine and telephone and Twitter exchanges between the governor and President Donald Trump.

DeWine issued an angry news release in the morning calling the FDA “reckless” for dramatically limiting the number of cleaned masks. It was a sharp rebuke from a Republican governor who until now has refrained from criticizing the Trump administration’s handling of the COVID-19 outbreak.

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DeWine talked to Trump later in the morning and said the president was willing to help.

“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,” DeWine tweeted.

Four minutes earlier, Trump had tweeted an article about the Battelle invention, commenting, “Highly recommended by Governor @MikeDeWine of Ohio. @FDA must move quickly!”

Then, Trump tweeted, “Hope 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.”

Officials in Ohio and elsewhere are scrambling for the N95 masks and other protective equipment for health care workers as the number of COVID-19 cases is expected to spike over the coming weeks. On Saturday, DeWine publicly pleaded with the FDA immediately to approve an emergency-use permit for Battelle’s technology amid a shortage of personal protective equipment, including masks.

The Battelle process uses “vapor phase hydrogen peroxide” to sanitize the N95 masks, allowing them to be reused up to 20 times, the company said in a statement.

The FDA has “only approved a fraction of what we can do,” DeWine said during the news conference.

In a written statement, DeWine accused the FDA of not having the backs of health workers in a time of national peril.

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

In a letter to Battelle, FDA Chief Scientist Denise Hinton didn’t give a reason for the tight limits the agency was putting on the technology, but it seemed as if regulators wanted to make sure the new technology works.

“Battelle is authorized to decontaminate up to 10,000 compatible N95 respirators per day, consistent with the data provided to FDA,” Hinton wrote. “Battelle shall provide FDA weekly reports, including data according to a testing plan for scale-up reviewed by FDA, regarding the decontamination of compatible N95 respirators, including any reductions in decontamination ability.”

Despite having to fight administration officials to fully implement a home-grown fix to supply problems, DeWine denied that he and other state officials are being left to manage the coronavirus crisis in the absence of federal leadership.

“It’s just the opposite,” he said. “Every time I’ve called the president, every time I’ve called the vice president, every time I’ve called the White House with a specific ask, they’ve gotten on it.”

Follow Marty Schladen on Twitter at @martyschladen.