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

Phenelle Segal to Co-Present Webinar on Resuming Clinical Operations

Infection Control Consulting Services (ICCS) Founder Phenelle Segal, RN, CIC, FAPIC, will co-present a complimentary webinar titled "Resuming Clinical Operations: Infection Prevention and Other Critical Considerations."

The program is scheduled for April 29, 2020, at 1:00 pm ET. Its description is as follows:

As states continue working toward how and when to safely relax coronavirus-related restrictions, medical groups, ambulatory surgery centers, and other providers that have ceased or greatly reduced their operations during the coronavirus pandemic are preparing to resume or expand them. But providers must do so with an understanding of how COVID-19 has impacted and will affect their clinical operations if they want to best ensure patient and staff safety as well as compliance with regulations and accreditation standards.

In this webinar, our experts will cover:

• Infection prevention and control for the "new normal"

• Safety considerations for patients and staff

• Regulatory and accreditation survey areas of focus

• Role of the governing board/leadership

• Quality assurance and performance improvement (QAPI)

To register, click here.

Joining Phenelle in presenting the program is Laurie Roderiques, director of nursing services for Ambulatory Healthcare Strategies.

The program is hosted by Medicus IT, a healthcare-focused managed service provider.

Study: Disinfection of 'Christmas Tree' Adaptors Prior to Reuse

The results of a new study support the importance of low-level disinfecting reusable oxygen nipple and nut adaptors (i.e., "Christmas tree adaptors") between patients.

For the study, which was published in The Society for Healthcare Epidemiology of America's Infection Control & Hospital Epidemiology, researchers examined the effectiveness of using disinfection wipes to eliminate bacteria from the devices. They tested two different types of wipes: 1) 0.5% hydrogen peroxide and 2) 0.25% tetra-ammonium chloride with 44.50% isopropyl alcohol.

The result: Both wipes effectively removed bacteria, leading the researchers to conclude: "Low-level disinfection of Christmas tree adaptors is appropriate prior to redeployment in the clinical setting."

ICCS urges providers to follow manufacturer recommendations for all medical devices as many Christmas tree adaptors are single-use and cannot be disinfected and reused. See this infection prevention tip on single-use versions.

ICCS COVID-19 Update: KN95 Masks, Steris EUA, CDC Guidance

For an update on some of the information discussed below, please see this post from May 11.

The COVID-19 pandemic continues to provide infection preventionists with unimaginable challenges. The biggest challenge is lack of continued implementation of “best practices” as they relate to use of personal protective equipment (PPE) and ventilators. Ongoing issues with lack of respirators (N95) and facemasks have also created significant chaos.

The Infection Control Consulting Services (ICCS) team is spending a tremendous amount of time monitoring ongoing updates at the federal, state and local levels. We are doing our best to share updates as they are presented, even if they do not align with traditional practices. We are fully aware that in a crisis situation, improvising and prioritizing while considering the safety of everyone is difficult and frustrating for our clients and all providers.

The following is a rundown of some recent updates concerning the novel coronavirus.

KN95 masks: Within the past two weeks, the FDA granted emergency use authorization (EUA) to several companies internationally, including China, to provide the U.S. with KN95 masks. Shipments are currently arriving. To view a list of KN95 EUA masks, click here.

ICCS has been informed of challenges with some of these masks, including them not fit testing properly. Fit testing kits are very difficult to obtain for facilities that have never needed to use them. Facilities with fit testing kits are finding it difficult to obtain the solution used to conduct the test. OSHA has not lifted its requirement for first time fit tests, but it has relaxed its annual requirements. In theory, if a KN95 respirator mask is used for aerosolized procedures (e.g., intubation, suction and nebulizer treatments), it must be fit tested.

At present, ICCS is suggesting that if you are unable to fit test the KN95 masks, use them in lieu of surgical masks and not for aerosolized procedures.

If a facility is going to perform seal fit checks, remind staff that they must not touch the mask before or after completing the test without washing/sanitizing hands. This process should be performed away from direct patient care. For directions on completing a user seal check, click here.

Steris EUA: The FDA has granted Steris an EUA, allowing the company to 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. Organizations with the V-Pro Low Temp autoclave will find the information in this link helpful.

CDC guidance: The CDC issued guidance late last week advising that critical infrastructure workers may be permitted to continue working to ensure continuity of operations of essential functions following potential exposure to COVID-19 provided they remain asymptomatic and additional precautions are implemented to protect them and the community.

ICCS COVID-19 Update: Shortage of Face Protection

Infection Control Consulting Services (ICCS) continues to update clients as this highly fluid pandemic evolves. This week's update includes caring for COVID-19 patients in your facility (now and future) with the main focus on critical issues related to the shortage of face protection.

ICCS recommends reviewing the following resources:

• Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings — Access resource >

• Strategies for Optimizing the Supply of Facemasks — Access resource >

• Duke Starts Innovative Decontamination of N95 Masks to Help Relieve Shortages — Access resource >

• What Healthcare Personnel Should Know about Caring for Patients with Confirmed or Possible COVID-19 Infection — Access resource >

• Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings — Access resource >

• Aerosol Generating Procedures — See chart below