Balderson, Stivers: FDA Should Allow Battelle at Full Capacity to Decontaminate Masks

COVID-19 Local News Stories

Congressmen Troy Balderson (R-OH) and Steve Stivers (R-OH) join Ohio Governor DeWine in calling 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 can be decontaminated using Battelle’s innovative new technology. Having enough PPE for frontline health care workers is crucial in the fight against the 2019 novel coronavirus (COVID-19) pandemic.

“We are facing a crisis in Ohio and around the country. 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 N95 masks at full capacity,” said Balderson and Stivers. “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. 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.”

Balderson and Stivers have been working with both Columbus-based Battelle and the FDA in recent weeks to push forward FDA approval of Battelle’s innovative sterilization technology. Two weeks ago, the two sent a letter with Congresswoman Joyce Beatty (D-OH), whose congressional district also covers part of Columbus, to FDA Commissioner Dr. Stephen Hahn seeking immediate review and approval of Battelle’s PPE decontamination technology.

Explained in its FDA emergency use authorization (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 reuse. The FDA announced that it is granting EUA for Battelle’s Decontamination System for up to 10,000 masks per day, rather than its full capacity of 160,000 masks per day. The EUA also fails to allow Battelle to employ its critical technology in the field, as Battelle had requested in order to get fresh PPE to the nation’s COVID-19 hotspots rapidly.