Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators.
The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA authorized the cycle for use on Steris’ Amsco medium-heat sterilizers, which the agency previously cleared.
The Dublin, Ireland-based company estimated that the new method could decontaminate more than 30 million respirators per day if all of its compatible U.S.-based sterilizers are fully employed.
Compatible N95 respirators will be individually pouched using sterilization pouches that are FDA-cleared for steam sterilization. They may be decontaminated by this process up to 10 times and be reusable only by the original users, according to the EUA.
This is the second EUA for Steris t…