ST. PAUL, Minn.– Ecolab Inc., the global leader in water, hygiene and infection prevention solutions and services that protect people and vital resources, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Bioquell Technology System to decontaminate specific N95 respirators.1 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.
“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,” said Elizabeth Simermeyer, Ecolab executive vice president and president, Global Healthcare and Life Sciences. “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 System2, Yale University3 and the U.S. Air Force Research Laboratory and National Institute for Occupational Health & Safety (NIOSH).4 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.
