FDA approves Battelle’s process to decontaminate N95 face masks

FDA approves Battelle’s process to decontaminate N95 face masks

The Food and Drug Administration has approved a process that would clean much-needed N95 protective face masks and allow them to be reused, the agency said in a release. Columbus-Ohio based Battelle uses a “vapor phase hydrogen peroxide” process to decontaminate the masks being used by healthcare providers and others to protect against the spread of COVID-19. Battelle says its Critical Care Decontamination Systems could decontaminate up to 80,000 masks per day.

Late Sunday night following criticism from Ohio Gov. Mike DeWine, the FDA lifted its restriction on the number of masks Battelle can decontaminate with its process. DeWine said on Twitter he had appealed to President Trump to lift the initial limit of 10,000 masks per day. The president later tweeted “Hope the FDA can approve Mask Sterilization equipment quickly.”

Several hours later, the FDA changed its emergency use authorization for Battelle’s process from “partial” to “full.”

N95 respirators are disposable, snug-fitting face masks that can keep virus-laden droplets away from a wearer’s mouth and nose. The Centers for Disease Control and Prevention notes that the masks’ effectiveness is “highly dependent upon proper fit and use.”

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