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Home Covid-19

STERILUCENT GRANTED EMERGENCY USE AUTHORIZATION TO REPROCESS RESPIRATORS

STERILUCENT GRANTED EMERGENCY USE AUTHORIZATION TO REPROCESS RESPIRATORS

Hydrogen peroxide process facilitates safe reuse of masks.

April 21, 2020: The U.S. Food and Drug Administration today issued an Emergency Use Authorization to Sterilucent, Inc. (Minneapolis, MN) to enable the emergency use of the SterilucentTM HC 80TT Vaporized Hydrogen Peroxide Sterilizer for the decontamination of single-use compatible N95 and N95-equivalent respirators.

Test results have shown that filtering facepiece respirators can be reprocessed for use in the COVID-19 pandemic in the HC 80TT Flexible Cycle up to 10 times without having a negative effect on filtration performance or a notable reduction in respirator fit. The system is capable of reprocessing up to 12 respirators simultaneously.

“We are glad to be able to help extend the safe use of PPE for healthcare staff during this time of overburdened supply chains,” said Chief Operating Officer Stephen Loes. “The HC 80TT sterilizer can provide timely internal turnaround of PPE that helps extend a facility’s inventory and better manage supply disruption or unavailability. Unlike other systems that dispense fixed volumes of chemistries for all load sizes for the chosen cycle, HC 80TT Cycle Guardian™ technology adjusts dynamically the delivery of the sterilant required according to the load in the chamber. The N95 load is a light load and, as such, the HC 80TT sterilizer dispenses less chemistry, causing less degradation of the respirator and reducing the cost per cycle for the facility.

3M offers a continually updated Technical Bulletin that addresses the CDC COVID-19 recommendations for decontamination of N95 respirators. The bulletin offers systems that are acceptable for mask reprocessing as well as systems to be avoided.  Sterilucent HC 80TT sterilizer is included in Table 1, which compiles the impacts of decontamination processes on 3M respirators.

For further details, or to purchase an HC 80TT Vaporized Hydrogen Peroxide Sterilizer, email: customer.care@sterilucent.com or phone: +1 612-767-3276.

About Sterilucent

Sterilucent, Inc. is a healthcare business that uses proven science and green technologies to create effective, innovative sterilization products. Our technologies assist in making reusable medical devices safe and properly presented for patient procedures, which leads to better global health and wellbeing. For further details, visit www.sterilucent.com.

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