FDA approves methods to sterilize N95 masks to be reused by hospitals

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The FDA has granted three emergency use authorizations allowing companies to sterilize N95 masks to be reused by hospital workers. 

The first approval was given to Battelle March 29 for its decontamination system, which can sterilize up to 10,000 masks per cycle with each cycle taking about 150 minutes. Each mask can go through a maximum of 20 cycles. 

On April 10 the FDA also approved Steris' sterilization systems, which use vaporized hydrogen peroxide to sterilize masks. Steris' systems can decontaminate about 750,000 masks per day, and each mask can be sterilized a maximum of 10 times. 

On April 12, it approved Advanced Sterilization Products' sterilization device, which uses vaporized hydrogen peroxide gas plasma sterilization. The system can decontaminate about 4 million masks per day.

The agency said it has made these approvals to help combat critical medical supply shortages that have affected hospitals across the country. 

"Our nation’s healthcare workers are among the many heroes of this pandemic, and we need to do everything we can to increase the availability of the critical medical devices they need, like N95 respirators," said FDA Commissioner Stephen Hahn, MD.

 

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