The U.S. Food and Drug Administration has approved Columbus-based non-profit Battelle’s request to begin sterilizing surgical masks for reuse during the COVID-19 coronavirus pandemic.
The FDA has amended its initial approval, granted early Sunday, now allowing Battelle to sterilize the N95 surgical masks without a daily limit.
The revised order authorizes Battelle to decontaminate up to 10,000 compatible N95 respirator masks per chamber load, with the machine able to process four chambers per sterilization process. Battelle said it can run two sterilization processes per machine per day, sterilizing 80,000 masks per machine.
Sterilized masks can be reused up to 20 times. Once that limit is reached, the masks are discarded. Battelle CEO Lewis Von Thaer said they are currently limited to only sterilizing N95 masks, but it is moving toward gaining approval for other PPE like ventilator parts.
The initial order from the FDA limited the number to 10,000 per day.