COVID-19 Update: Phase 1 Reopening and Ongoing Masks Shortage

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As the country begins to phase in an economic recovery plan which includes reopening ambulatory surgery centers (ASCs) and other outpatient offices, significant issues continue with an extreme shortage of personal protective equipment (PPE), including respirator and other masks for healthcare workers. Hospitals have found themselves in crisis mode since the first cases were identified in the United States as stocks of N95 respirator masks continue to be in short supply. Here is an update on a few of the most significant recent developments concerning the pandemic and infection prevention and control.

Reprocessing N95 Masks

Hospitals in desperation have resorted to reprocessing N95 respirator masks that were intended for single use prior to the COVID-19 crisis. The Food and Drug Administration (FDA) evaluated several methods of reprocessing and has issued emergency use authorization (EUA) documents to companies to reprocess and recycle used N95 masks. In a previous post from Infection Control Consulting Services (ICCS), accessible here, ICCS provided the methods and companies responsible for providing these services.

Guidelines for Aerosol-Generating Procedures

As noted, ASCs and other outpatient settings are slowly resuming and working to ramp up operations to conduct elective procedures and routine visits. These services include several aerosol-generating procedures (AGPs) that put frontline workers at potential risk. The list of approved procedures continues to grow as the Centers for Disease Control (CDC), various medical societies, organizations and associations add to it.

CDC advises that clinicians providing direct care for patients likely to undergo an AGP must, at a minimum, don N95 respirator masks that are National Institute for Occupational Safety and Health (NIOSH) approved and fit tested as per the Occupational Safety and Health Administration (OSHA) (29 CFR 1910.134). In addition to respirator masks, additional PPE is necessary to protect the staff. This includes eye protection and face shields.

Examples of resources concerning aerosol-generating procedures include the following:

Challenges for Outpatient Settings

NIOSH N95 respirator masks were not typically worn by staff in outpatient settings until COVID-19 emerged. In the early days of the pandemic, the CDC requested outpatient surgery centers withhold ordering these masks to allow hospitals to maximize their inventory. They were needed for hospital critical care and emergency department staff whose exposure to droplets is highest.

Priority has and continues to be given to hospitals and other service providers who have kept inventory in the past. By the time ASCs and outpatient providers began reopening at the beginning of May, there were very few supplies within the United States to distribute. Pressure to ease the shortage of respirator masks in New York and elsewhere led the FDA to add Chinese-made N95 masks to their suggestions for additional supplies even though they were not approved by NIOSH. As a result, on April 3, the Food and Drug Administration (FDA) issued EUAs for masks from China, which eased the flow of supplies and allowed outpatient and hospital providers to obtain much needed supplies.

In addition to these respirator masks from China, the FDA issued EUAs for KN95 masks that were not considered respirator masks but were often confused with the N95 products. Several hospitals were attempting to fit test the KN95 masks, but these masks were failing the tests. It soon became apparent that KN95s should be used as facemasks only and not as a means to protect healthcare personnel from aerosol-generating procedures.

Unfortunately, the FDA recently became aware of issues associated with the N95 masks from China. Based on filtration performance testing conducted by NIOSH, it was determined that certain respirator masks did not provide adequate and consistent protection for users. This forced FDA to issue a revised EUA on May 7, removing respirators that did not meet certain standards and were therefore, no longer eligible nor authorized to be marketed or distributed as respirator masks within the US.

The FDA advised that Chinese manufacturers can relabel their N95 masks if they meet certain criteria. The KN95 masks list is undergoing continuous updates as companies are added or deleted.

Guidance from Infection Control Consulting Services

Since the announcement that outpatient facilities are resuming services, ICCS has advised its ambulatory surgery center and outpatient provider clients that N95 respirator masks must be fit tested before being used for aerosol-generating procedures. Furthermore, KN95 respirator masks should be considered as face masks only and not as respirator masks as they were not NIOSH approved.

In addition, ICCS has been assisting outpatient facilities with reusing, repurposing and reprocessing NIOSH-approved N95 masks, particularly those surgery centers fortunate to have some supplies and the use of ASP’s Sterrad sterilizer that utilizes hydrogen peroxide and is authorized by the FDA for reprocessing, as per manufacturer’s instructions for use. Providing a certain number of approved N95 masks to each staff member who will be potentially exposed to AGPs and having them rotate their supplies (using various methods) is an option as well.

COVID-19 Assistance from Infection Control Consulting Services

The team of consultants with Infection Control Consulting Services, led by ICCS President and Founder Phenelle Segal, continues to monitor updates and changes as they arise. ICCS provides clients with updates weekly or more frequently, when significant developments occur. Learn more about ICCS COVID-19 assistance services.

Ask the Expert: Decontamination of N95 Respirator Masks

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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

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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

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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.