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Ecolab's Bioquell Technology System For N95 Respirator Decontamination Gets EUA From FDA

Ecolab Inc. (ECL) said Friday that it has received Emergency Use Authorization or EUA from the U.S. Food and Drug Administration for its Bioquell Technology System to decontaminate specific N95 respirators.

The EUA is for Ecolab's Bioquell BQ-50 and Bioquell ProteQ decontamination systems and will enable healthcare facilities to decontaminate respirators on-site to help address continuing respirator shortages.

Ecolab noted that using its Bioquell Technology System, specified N95 masks can be decontaminated up to four times for reuse by healthcare professionals to help prevent exposure to SARS-CoV-2 and other pathogenic biological airborne particulates.

This proprietary system creates a hydrogen peroxide vapor technology that eliminates pathogens from every exposed surface within an enclosed area, providing a 99.9999% reduction of bioburden.

However, Ecolab noted that its Bioquell Technology System has neither been cleared nor approved by FDA, but has been authorized for emergency use by FDA.

The emergency use of Ecolab's Bioquell Technology System is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices during the COVID-19 outbreak.

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