The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers. In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. […]
Battelle Memorial Institute
The FDA is warning Battelle Memorial Institute that it must improve its adverse event reporting procedure for decontaminating N95 masks for reuse by frontline healthcare workers treating COVID-19 patients. The agency granted an emergency use authorization (EUA) in March for the Battelle Critical Care Decontamination System (CCDS), which uses vaporized hydrogen peroxide to reprocess used N95 […]
The U.S. Defense Dept. handed out contracts worth millions of dollars for medical devices and research to Welch Allyn, Battelle Memorial Institute and 2 radiology companies.