FDA eases restrictions on mask-sterilizing technology amid coronavirus shortages

FDA eases restrictions on mask-sterilizing technology amid coronavirus shortages

COLUMBUS, OH -- Ohio Gov. Mike DeWine Sunday afternoon said federal officials have promised to ease restrictions on a technology to clean and reuse the masks deemed the safest for healthcare workers and first responders in the coronavirus outbreak.

U.S. Food and Drug Administration Commissioner Steve Hahn told DeWine that “this would be cleared up today,” DeWine said at a Sunday afternoon press conference.

It comes after DeWine issued an angry press release in which he said the FDA was “reckless” for sharply limiting the number of protective masks Columbus-based research firm Battelle can sterilize using a process it developed.

Officials 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 months. On Saturday, DeWine publicly pleaded with the FDA to approve an emergency-use permit for Battelle’s technology amid a shortage of personal protective equipment, including masks.

The U.S. death total has doubled in two days, climbing above 2,300 Sunday. Dr. Anthony Fauci, who has been a leading voice in the effort to curb the outbreak, said 100,000 to 200,000 Americans could die before the crisis is over.

DeWine said those numbers make it urgent for the FDA to clean as many masks as it can. Battelle has produced two machines for Ohio and has plans to ship others to New York, Seattle and Washington, D.C., DeWine said.

The Battelle process uses 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. Each of the company’s Critical Care Decontamination Systems can sterilize 80,000 masks per day, Battelle said. One has been sent to New York and two are available to Ohio, Battelle said.

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DeWine on Sunday said the FDA authorized Battelle to sterilize just 10,000 surgical masks a day.

“They’re only approved a fraction of what we can do,” DeWine said during the press conference.

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

"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 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 added, “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 letter to Battelle, FDA Chief Scientist Denise Hinton didn’t give a reason for the tight limitations the agency was putting on Battelle, but it seemed as if regulators wanted to make sure it worked.

“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.”

A Battelle spokeswoman said her organization would continue to work with the FDA.

“We are thankful that the Food and Drug Administration granted Emergency Use Authorization to operate Battelle CCDS at our facilities,“ the spokeswoman, Katy Delaney, said. ”We continue to work with FDA to maximize the impact of the Critical Care Decontamination System by expanding use to other locations as well as increasing the number of respirator masks that are allowed to be processed each day."

Follow Marty Schladen on Twitter at @martyschladen.

Source: https://www.usatoday.com/story/news/nation/2020/03/29/coronavirus-fda-eases-restrictions-mask-sterilization-technology/2936670001/

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