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 to decontaminate used N95 respirators. In April, the FDA authorized a Steris vaporized hydrogen peroxide system to reprocess up to 750,000 N95 respirators and equivalent masks per day in hospitals treating COVID-19 patients.
“It is encouraging to see a number of EUAs by Steris and other companies being authorized for hospitals to safely reuse respirators during this pandemic,” said Steris president & CEO Walt Rosebrough in a news release. “Our people leveraged their extensive knowledge once again to assist the caregivers on the front lines. Steris will install the upgraded cycle needed to decontaminate respirators at no charge for healthcare providers who coordinate the upgrade with other maintenance at their facility. Once again, we appreciate the collaboration with 3M and the guidance of the FDA.”
Shares of STE were up 1.72% to $160.42 in early afternoon trading.