by Brianna Crandall — January 22, 2021 — Ecolab, a global provider of water, hygiene and infection prevention solutions and services that protect people and vital resources, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) 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 enables healthcare facilities to decontaminate respirators on-site to help address continuing respirator shortages.
Leveraging Ecolab’s leading decontamination expertise providing solutions that help prevent hospital-acquired infections in critical care areas and help ensure pharmaceutical manufacturing cleanrooms remain sterile, the Bioquell Technology System uses a proprietary hydrogen peroxide vapor technology for respirator decontamination.
Elizabeth Simermeyer, Ecolab executive vice president and president, Global Healthcare and Life Sciences, remarked:
As healthcare facilities continue to experience shortages of respirators amidst a surge in Covid-19 cases in the United States, and with large-scale vaccination on the horizon, the ability to reuse this essential personal protective equipment brings additional protection to frontline workers. This Emergency Use Authorization from the FDA gives healthcare facilities added flexibility to confidently deploy Bioquell technology to decontaminate respirators on-site.
Using Ecolab’s Bioquell Technology System, specified N95 masks can be decontaminated up to four times for reuse by healthcare professionals to help prevent exposure to airborne pathogenic 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 (6 log10 sporicidal kill).
This technology is used in life science product manufacturing facilities and in healthcare facilities throughout the world to eliminate harmful organisms and emerging pathogens in operating rooms, critical care areas, patient rooms and ambulances.
In Canada, Health Canada has granted a similar emergency authorization for Ecolab’s Bioquell Technology System for respirator decontamination.
Bioquell’s technology for the decontamination of N95 respirators has been the subject of several studies, including studies by Duke University Health System, Yale University and the US Air Force Research Laboratory and National Institute for Occupational Health & Safety (NIOSH). See the Bioquell Studies and Publications page for links to the studies.
Ecolab and Bioquell will provide healthcare facilities with guidance, training and technical support to reprocess N95 masks using Bioquell technology, consistent with the process outlined in the FDA Emergency Use Authorization and information published by Duke University Health System. The FDA previously granted EUAs for decontamination systems utilizing Bioquell hydrogen peroxide vapor technology and services to collect and return decontaminated respirators to selected healthcare facilities.
For more information on Ecolab’s Bioquell Technology System including the FDA’s Emergency Use Authorization for the decontamination of N95 respirators, visit the Bioquell N95 webpage.
Ecolab notes that its Bioquell Technology System has neither been cleared nor approved by FDA, but has been authorized for emergency use by FDA under an EUA for the decontamination of compatible N95 respirators for single-user reuse by HCP to prevent exposure to the SARS-CoV-2 coronavirus that causes Covid-19, and other pathogenic biological airborne particulates.
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, under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Virasept
Ecolab also announced that it is the first to receive EPA product approval for disinfection of biofilms in wastewater drains for its Virasept product — part of a comprehensive environmental hygiene program designed to help effectively combat bacterial growth in hospitals. Find out more on the Ecolab website.
Ecolab delivers comprehensive solutions, data-driven insights and personalized service to advance food safety, maintain clean and safe environments, optimize water and energy use, and improve operational efficiencies and sustainability for customers in the food, healthcare, hospitality and industrial markets in more than 170 countries around the world.
