FDA Issues Emergency Use Authorization to ASP to Decontaminate Nearly 4 Million N95 Masks

By MedTech Intelligence Staff

Advanced Sterilization Products received an EUA for the STERRAD Sterilization Cycles.

Yesterday FDA issued an emergency use authorization (EUA) for the STERRAD Sterilization Cycles, manufactured by Advanced Sterilization Products), for use on N95 Respirators. The EUA could enable the decontamination of up to 4 million N95 or N95-equivalent respirators.

“Our nation’s health care 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 M. Hahn, M.D. in an agency press release. “This authorization will help provide access to millions of respirators so our health care workers on the front lines can be better protected and provide the best care to patients with COVID-19.”

The STERRAD Sterilization Cycles uses vaporized hydrogen peroxide gas plasma sterilization. The system includes the STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle, which can reprocess N95 respirators in 55 minutes, 28 minutes and 24 minutes, respectively—with each having the ability to reprocess up to 480 respirators daily.

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