International assessment results on non-NIOSH approved respirators by the national personal protective technology laboratory (NPPTL): a data note.

OBJECTIVES: Due to the COVID-19 pandemic and the shortage of the National Institute for Occupational Safety & Health (NIOSH)-approved N95 respirators, the Food and Drug Administration granted an Emergency Use Authorization to allow the use of non-NIOSH approved respirators provided that these respirators must undergo tests by a protocol of TEB-APR-STP-0059, similar methods of NIOSH standard testing procedure. This initiative safeguards the quality of respirators and the effectiveness of occupational protection. The dataset of all the testing results could benefit further analysis of COVID-19 infection rates in relation to different types of N95 respirators used and identify potential correlations of various test parameters in the testing system for validation. The analysis enhances understanding of the quality, effectiveness, and performance of N95 respirators in the prevention of respiratory infectious transmission and develops improved occupational safety measures. DATA DESCRIPTION: The dataset was transformed, transcribed, and compiled from the official testing data of non-NIOSH-approved N95 respirators reported in the NIOSH website under the Centers for the Disease Control and Prevention in the United States. The dataset included details of 7,413 testing results of N95 respirators (manufacturer, model, and maximum and minimum filtration efficiency) and test parameters (flow rate, initial filter resistance, and initial percent leakage). Supplementary items were added to increase the availability of data analysis and enhance the interpretability of the assessments of the quality of N95 respirators.

Elastomeric Half Mask Respirators: An Alternative to Disposable Respirators and a Solution to Shortages during Public Health Emergencies.

During public health emergencies such as an influenza pandemic, disposable filtering facepiece respirator (FFR) shortages have a significant impact on the national response, affecting many types of workplaces that rely on respiratory protection. During the COVID-19 pandemic, severe FFR shortages led the CDC to publish strategies for optimizing the supply of N95 FFRs. These strategies included the extended use and limited reuse of FFRs, wearing decontaminated FFRs, wearing respirators that meet an international respirator standard, or wearing FFRs that were past their manufacturer-designated shelf life. An additional strategy to mitigate supply shortages that was highlighted during the COVID-19 pandemic was to wear reusable respirators, such as elastomeric half mask respirators (EHMRs), or powered air-purifying respirators, which can be cleaned, disinfected, and reused. A decade of nationwide initiatives to increase the utility of EHMRs in healthcare settings were realized during the COVID-19 pandemic as EHMRs became more well-known and were used in healthcare settings for respiratory protection. This expanded use of EHMRs led to an increase in federal procurement, research, guidance, and private sector research and development of innovative EHMR designs by manufacturers to respond to workers' needs for both respiratory protection and source control. This paper describes the role of reusable EHMRs before and during the COVID-19 pandemic, and reviews past and current research, to inform successful EHMR implementation in healthcare and first responder settings.

A General Framework to Test and Evaluate Filtering Facepiece Respirators Considered for Crisis Capacity Use as a Strategy to Optimize Supply.

During a public health emergency, respirator shortages can have a profound impact on the national response, such as for the current coronavirus disease 2019 (COVID-19) pandemic. Due to a severe shortage of respirators (particularly filtering facepiece respirators [FFRs]), there may be contexts in which understanding the performance of FFRs that are approved for use as part of a crisis capacity strategy is desired. This includes FFRs that are not covered under the National Institute for Occupational Safety and Health (NIOSH) Respirator Approval Program because they have been stored past their designated shelf life, have been decontaminated, or are approved by international certification bodies other than NIOSH. The purpose of this document is to provide a general framework to assess the performance of FFRs that are only being used as a crisis capacity strategy. The intended audience are those who are responsible for managing large amounts of FFRs. This framework includes a four-step process consisting of: 1) defining the population of FFRs to be sampled; 2) providing sampling strategy options; 3) inspecting and testing the sampled units; and 4) evaluating the results. In addition to the four-step process, we provide an example of how NIOSH recently evaluated the quality of FFRs sampled from ten U.S. stockpiles.

Planning for Epidemics and Pandemics: Assessing the Potential Impact of Extended Use and Reuse Strategies on Respirator Usage Rates to Support Supply-and-Demand Planning Efforts.

During epidemics and pandemics healthcare personnel (HCP) are on the front line of disease containment and mitigation. Personal protective equipment (PPE), such as NIOSH-approved N95 filtering facepiece respirators (FFRs), serve an important role in minimizing HCP risks and are in high demand during public health emergencies. Because PPE demand can exceed supply, various public health strategies have been developed to reduce the rate of PPE consumption as supply dwindles. Extended use and limited reuse of N95 FFRs are strategies advocated by many governmental agencies used to increase the number of times a device can be used. Increased use of respirators designed for reuse-such as powered air-purifying respirators (PAPRs) and elastomeric half-mask and full facepiece air-purifying respirators- is another option designed to reduce the continuous need for new devices as the daily need for respirator use increases. Together, these strategies are designed to reduce the number of PPE units that must be discarded daily and, therefore, extend the longevity of available supply. The purpose of this paper is to theoretically estimate the impact of extended use and limited reuse strategies for N95 FFRs and the increased use of reusable respirator options on PPE consumed. The results suggest that a considerable reduction in PPE consumption would result from extended use and limited reuse of N95 FFRs and the increased use of respirators designed for reuse; however, the practical benefits must be balanced with the risks and economic costs. In addition, extended use and reuse strategies must be accompanied by proper procedures to reduce risk. The study is designed to support epidemic and pandemic PPE supply and demand planning efforts.