FDA warns mask-cleaner Battelle over inadequate reporting

FDA on Wednesday sent an accountability warning letter to the nonprofit Battelle Memorial Institute, a federal contractor that received a deal worth hundreds of millions of dollars to disinfect used N95 masks for health care workers. FDA says Ohio-based Battelle has a substandard process for reporting issues related to its mask-decontamination system, even though the company is required to have a reporting system as part of FDA’s emergency use authorization for the system that the agency granted in March. FDA says earlier this year, Battelle forwarded approximately 100 potential issues related to use of the system, including rashes, chemical odors, or leaving users short of breath. The Wall Street Journal in June reported safety concerns about Battelle’s process to disinfect masks and certain adverse-event reports associated with it. Battelle said Thursday it has put 2.9 million masks through its system, which involves exposing used masks to vaporized hydrogen peroxide for a few hours. The masks are aired out to reduce the concentration of the chemical. Battelle said it would submit a response to the FDA in the coming days.