Decontamination of filtering facepiece respirators with hydrogen peroxide vapor –principles, technologies and systems

FFI-Report 2020

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20/01742

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978-82-464-3238-3

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Line Victoria Moen Else Marie Fykse Marius Dybwad

Sufficient access to respiratory protection equipment is a prerequisite for the healthcare system to cope with the challenges during the novel coronavirus (SARS-CoV-2) pandemic. The corona pandemic has led to a global shortage of filtering facepiece respirators, which are the type of masks used in the health care system. These respirators are normally not approved for decontamination and reuse. Decontamination and reuse of respirators can be considered in a pandemic emergency situation where the demand for equipment is higher than the supply. A rapid increase in demand and consumption can occur due to a new major infection peak in the ongoing corona pandemic.

The decontamination method must not destroy the filtering properties and capacity of the respirators or affect the facepiece fit. Decontamination of respirators must inactivate SARSCoV-2 and other infectious agents. In addition, there must be no harmful residues of disinfectants in respiratory protection after decontamination, which may pose a risk of contact or inhalation to the user.

National and international communities have suggested several technologies and procedures for decontamination of respiratory protection in conjunction with previous pandemic situations, and recently during the ongoing corona pandemic. One of the decontamination methods already in use is hydrogen peroxide vapor (HPV). The Norwegian Defence Reseach Establishment (FFI) has reviewed the research and literature, and this report provides an overview of the principles, technologies and systems for hydrogen peroxide-based decontamination of respiratory protection for reuse.

Hydrogen peroxide is a powerful and effective disinfectant. It is used for decontamination (disinfection/sterilization) of medical equipment and rooms, mainly in vapor (HPV) or aerosol (aHP) form. Hydrogen peroxide break down to water and oxygen, and leaves no harmful toxic residues. Seven HPV-based systems (by 12 June 2020) have received an Emergency Use Authorization (EUA) in the USA from U.S. Food and Drug Administration (FDA) for decontamination of N95 respirators for reuse by healthcare personnel. Batelle Memorial Institute (USA) received the first approval for a container-based solution. Later, Duke University Hospital and Stryker Sustainability Solution (both USA) have also received approval for room-based solutions. These systems have high capacity (decontamination of 800–60,000 respirators simultaneously), and the received authorization is for multiple-user reuse (healthcare personnel may receive a different respirator following decontamination).

Several sterilization systems based on HPV from four US companies (STERIS, Advanced Sterilization Products, Stryker and Sterilucent) have also received EUA. These systems are fast but have limited capacity (decontamination of 10–20 respirators simultaneously), and the received authorization is for single-user reuse (healthcare personnel must receive their own respirator following decontamination ). Fewer aHP-based systems have been tested, and to this day, there is no such approval for aHP-based systems.

About publication

Report number

20/01742

ISBN

978-82-464-3238-3

Format

PDF-document

Size

812 KB

Download publication

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