The FDA issued an emergency use authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS). This product uses vapor hydrogen peroxide (VHP) to decontaminate compatible N95 respirators that are, or potentially are, contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. N95 respirators containing cellulose-based materials are incompatible with the SSS VHP N95 RDS. This system is operated by employees of Stryker Sustainability Solutions, whose facilities are designed to allow adequate space for receiving respirators for decontamination, visually inspecting respirators for gross contamination or damage, exposing respirators to VHP, and packaging or labeling them for return to the sender so as to minimize contamination and ensure orderly handling procedures. With respirators limited to a maximum of three decontaminations, each is permanently marked to indicate the number of decontamination cycles it has undergone.
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