FDA approves emergency use of Battelle sterilization technology


WASHINGTON – After Congressman Troy Balderson (R-OH) earlier called on the U.S. Food and Drug Administration (FDA) to immediately correct an oversight limiting the amount of life-saving personal protective equipment (PPE) that Battelle can decontaminate using its innovative technology, the FDA announced an emergency use authorization (EUA) of the technology at Battelle’s full capacity.

Background information — Explained in its FDA EUA request, Battelle’s technology can sterilize 20,000 N95 masks per cycle per chamber through a 3-hour decontamination process, resulting in the safe production of up to 160,000 masks per day for safe reuse. The FDA previously announced it was granting an EUA for Battelle’s Decontamination System for up to 10,000 masks per day, rather than its full capacity.

“This is a major win for not only Ohio, but our entire country as our health care system combats the coronavirus pandemic,” said Balderson. “Having enough protective gear is critical to the safety of our health care workers and slowing the spread of this virus. Battelle’s breakthrough technology will dramatically extend our supply of masks.”

The EUA of Battelle’s innovative decontamination technology at full capacity comes after Congressmen Balderson and Steve Stivers (R-OH), as well as Governor Mike DeWine, called on the FDA to immediately correct an oversight limited the authorized use of the technology to 10,000 masks per day.

In recent weeks, Balderson has actively engaged the White House, FDA, and Vice President’s Coronavirus Task Force in pushing forward approval of Columbus-based Battelle’s technology. This includes sending a letter with fellow Columbus-area Representatives Stivers and Joyce Beatty (D-OH) to FDA Commissioner Dr. Stephen Hahn seeking immediate review and approval of the PPE decontamination technology.


Staff report

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