FDA approves Battelle’s process to decontaminate N95 face masks but limits it to 10,000 per day

The Food and Drug Administration has approved the limited use of a process that would purify and reuse much-needed N95 protective face masks, the agency said. in a release. Based in Columbus-Ohio, Battelle uses a “vapor phase hydrogen peroxide” process to disinfect the masks used by health care providers and others to protect against the spread of COVID-19. Battelle says they are critical care disinfection systems can disinfect up to 80,000 masks per day.

But the FDA limits the number of masks that Battelle can sanitize with his process to 10,000 a day. As of the FDA release:

Battelle is authorized to sanitize up to 10,000 compatible N95 masks per day, in accordance with data provided to the FDA. Battelle will provide weekly FDA reports, including data according to an FDA-assessed upscaling test plan, regarding the decontamination of compatible N95 respirators, including any reductions in decontamination potential

Ohio Governor Mike DeWine criticized the limit as “reckless”, according to the Columbus Dispatch. “Battelle’s innovative technology can protect healthcare workers and first responders in Ohio and across the country, but during this time of crisis, the FDA has decided not to support people who risk their lives to save others,” DeWine said in a statement .

It was not immediately clear why the FDA had decided to limit the number of masks that could disinfect Battelle per day. We’ve contacted the agency for comment and will update it if we hear anything.

N95 masks are disposable, form-fitting face masks which can keep virus droplets away from the wearer’s mouth and nose. The Centers for Disease Control and Prevention notes the effectiveness of the masks is “highly dependent on proper fit and use.”

Leave a Comment