Ask the Expert: Decontamination of N95 Respirator Masks
Q: Since the surge in COVID-19 patients admitted to our hospital, we have experienced a critical shortage of N95 respirator masks. Are there currently any ways for us to reuse these masks?
Phenelle Segal, President, Infection Control Consulting Services: Yes, there are ways you can decontaminate the masks. The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to several companies to perform reprocessing. Traditionally, in a non-pandemic period, respirator masks are not approved to undergo this process, nor are they marketed in this manner. However, the COVID-19 pandemic has resulted in taking steps that are unconventional.
The following companies and systems have been granted an FDA EUA to date*:
ASP – Sterrad Vaporized Hydrogen Peroxide
"It will allow hospitals to decontaminate compatible N95 respirators using vaporized hydrogen peroxide sterilizers that are readily available in approximately 2,000 U.S. hospitals." This would provide about 750,000 cleaned masks on a daily basis, with each being reprocessed up to 10 times. Learn more ->
Stryker – Sterizone
"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the STERIZONE VP4 N95 respirator decontamination cycle may be effective at preventing exposure to pathogenic airborne particulates by decontaminating, for a maximum of 2 decontamination cycles per respirator, compatible N95respirators." The Sterizone VP4 uses vaporized hydrogen peroxide to sterilize up to 20 of the masks in one cycle. Learn more ->
Sterilucent – HC 80TT
"HC 80TT vaporized hydrogen peroxide sterilizer may now be used to decontaminate the single-use compatible respirators that are in high demand among health providers treating people with COVID-19. Test results showed that filtering facepiece respirators may be reprocessed up to 10 times in the HC 80TT flexible cycle without a detrimental impact on performance or a reduction in respirator fit. The system is capable of reprocessing up to 12 respirators at one time." Learn more ->
Batelle Memorial Institute – CCDS Critical Care Decontamination System
Each Battelle CCDS Critical Care Decontamination System is capable of decontaminating up to 80,000 masks per day at full capacity. Since it is scalable, the system is capable of processing even more pieces of personal protective equipment (PPE) each day. Battelle CCDS uses concentrated, vapor phase hydrogen peroxide (VPHP) and works by exposing used respirator masks to the validated concentration level for 2.5 hours to decontaminate biological contaminates, including SARS-CoV-2. Learn more ->
STERIS – V-PRO Low Temperature Sterilization System
STERIS can temporarily provide a distinct option to effectively decontaminate compatible N95 or N95-equivalent respirators up to 10-times using the non-lumen cycle of the V-PRO Low Temperature Sterilization System. Learn more ->
ICCS suggests hospitals and other facilities interested in utilizing these systems and methods to conduct a risk assessment and keep informed of updates regarding decontaminating N95 masks as COVID-19 continues to be a very fluid situation. Additional companies may be added to the EUA list, and it is expected that optimizing use of N95 respirator masks will continue to be updated.
* Information current as of April 23, 2020