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.
