ASP receives FDA emergency use authorisation to decontaminate N95 respirators

13 April 2020 (Last Updated April 13th, 2020 11:29)

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Advanced Sterilization Products (ASP) for its STERRAD Sterilization Cycles to decontaminate millions of N95 respirators.

ASP receives FDA emergency use authorisation to decontaminate N95 respirators
STERRAD Sterilization Cycles uses vaporised hydrogen peroxide gas plasma sterilisation to decontaminate N95 respirators. Credit: engin akyurt on Unsplash.

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The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Advanced Sterilization Products (ASP) for its STERRAD Sterilization Cycles to decontaminate millions of N95 respirators.

The STERRAD Sterilization Cycles, which uses vaporised hydrogen peroxide gas plasma sterilisation, includes STERRAD 100S Cycle, STERRAD NX Standard Cycle, and STERRAD 100NX Express Cycle.

These sterilisation cycles differ in reprocessing times from 55 minutes, to 28 minutes, and 24 minutes. Each is capable of reprocessing almost 480 respirators on a daily basis.

ASP noted that there are around 9,930 STERRAD Sterilization systems in about 6,300 US hospitals.

The authorisation will allow decontamination of about four million N95 or N95-equivalent respirators per day in the country for reuse by health care workers in hospitals fighting coronavirus (Covid-19).

FDA Commissioner Stephen Hahn said: “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.

“FDA staff continue to work around the clock, across government and with the private sector to find solutions. This authorisation 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.”

ASP designs and develops various infection prevention solutions.

Meanwhile, the Covid-19 cases in the US have reached 5,57,571. Latest reports suggest that the death toll has jumped to 22,108 in the country.