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FDA approves full use of mask sterilizing system

At first, the FDA only approved limited use of the technology. Now it can be used fully.
Credit: 10TV

COLUMBUS, Ohio — The U.S. Food and Drug Administration approved Columbus-based Battelle’s system that can decontaminate thousands of masks a day, according to a statement from the company.

Battelle told 10TV on Sunday night that the approval is for the use of the technology at “full capacity.”

According to a press release sent Sunday night from Battelle, the company’s CCDS Critical Care Decontamination System is now operating at Battelle’s West Jefferson, Ohio, facility.

The facility is capable of decontaminating up to 80,000 respirator masks per system each day using concentrated, vapor phase hydrogen peroxide.

According to a Sunday night statement from Ohio Gov. Mike DeWine's office, Battelle intends to send one machine to New York City and one to Stony Brook, New York. Machines will also be dispatched to the state of Washington.

Earlier Sunday, the FDA only approved limited use of the technology at 10,000 surgical masks in the state a day, which was met by criticism from DeWine.

In a press conference on Sunday, DeWine said President Donald Trump assured him that the approval would be handled quickly.

According to Battelle, the respirator masks are exposed to the validated concentration level for 2.5 hours to decontaminate biological contaminates, including COVID-19. The system can decontaminate the same respirator mask up to 20 times without degrading the mask’s performance.

“I want to thank the FDA team for their professionalism and help in authorizing the use of our technology at this critical moment for our nation,” said Lou Von Thaer, President and CEO of Battelle in a statement. “Everybody who has worked on this project shares the same goal of protecting first responders and healthcare workers who are at the front lines of the pandemic.”

"I want to thank President Trump for his leadership and Dr. Hahn of the FDA for approving the use of this life-saving technology that Battelle has developed," said DeWine in a statement. "This will not only help Ohio's healthcare workers on the front lines of the COVID-19 crisis, but Battelle will also be helping health care workers in hot spots throughout the country including New York and Washington state."