Balderson, Stivers secure FDA approval for Ohio-made mask decontamination machines

Thanks to the efforts of U.S. Reps. Troy Balderson (R-OH) and Steve Stivers (R-OH), the U.S. Food and Drug Administration (FDA) this week approved Columbus, Ohio-based Battelle’s system to decontaminate thousands of protective masks each day that will be used to limit the spread of the coronavirus.

“We are facing a crisis in Ohio and around the country,” said Rep. Balderson and Rep. Stivers in a joint statement released on March 29. “The number of cases will continue to grow in the coming weeks, and we need to do everything we can to ensure there is enough equipment to fight this battle, including allowing Battelle to sterilize N-95 masks at full capacity.” 

The congressmen recently joined Ohio Gov. Mike DeWine in urging the FDA to immediately correct an oversight limiting the amount of life-saving personal protective equipment (PPE) that could be decontaminated using Battelle’s innovative technology.

The representatives also sent a March 18 letter, also signed by U.S. Rep. Joyce Beatty (D-OH), to FDA Commissioner Stephen Hahn seeking immediate review and approval of Battelle’s innovative sterilization technology.

“Battelle, the largest independent research and development nonprofit in the world, and OhioHealth, the largest healthcare system in central Ohio, have established a process to collect used N-95 masks at OhioHealth, decontaminate them at Battelle, and return them to OhioHealth,” the lawmakers wrote. “In order for decontaminated N-95 PPE masks to be placed back into the clinical setting, hospitals such as OhioHealth need FDA approval as soon as possible.”

The FDA announced on March 29 that it had granted an emergency use authorization for Battelle’s Critical Care Decontamination System operating at Battelle’s West Jefferson, Ohio, facility, which 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 Gov. DeWine’s office, Battelle intends to send one machine each to New York City and Stony Brook, N.Y., as well as several machines to the State of Washington.

“Now is not the time to allow bureaucracy to stand in the way of life-saving innovation, and the FDA must reconsider and take corrective action immediately,” Reps. Stivers and Balderson said this week. “We have engaged the White House, FDA, and Coronavirus Task Force on this matter and will continue to push to ensure that our health care workers have the tools they need to fight this virus.”