PPE CASE – Evaluation of Fit and Strap Extension Performance of Stockpiled Filtering Facepiece Respirators from One U.S. Facility
NPPTL Report Number P2021-0102
National Institute for Occupational Safety and Health
National Personal Protective Technology Laboratory
In the event of a national emergency, eighteen million U.S. healthcare workers may face exposure to high-consequence infectious disease [NIOSH 2017]. Personal protective equipment (PPE), such as gowns, gloves, goggles, and respirators, is an important control measure within the infection prevention hierarchy of controls. During public health emergencies, the sudden increase in PPE demand may exceed supplies for upwards of three months while manufacturers increase production [ASTHO 2013; Carias et al. 2015; Patel et al. 2017]. Recent outbreaks—even those that occurred without extensive impact on US operations (e.g., 2009 H1N1 pandemic, 2016 Ebola outbreak)—caused respirator shortages; when the first U.S. fatality was reported during the Ebola outbreak, the PPE orders increased 10-200 fold [CDC 2021; DHHS 2012; NIOSH 2018]. To prepare for these surge demands, emergency planners stockpile large quantities of PPE at federal and state levels to support local supplies [Patel et al. 2017]. At the onset of this study in 2017, these products had been stored for more than five or even ten years. NIOSH-approved N95 filtering facepiece respirators (FFRs) are commonly used particulate-only air-purifying respirators (APRs) by many healthcare facilities so they are a commonly stockpiled product. NIOSH does not require approval holders (i.e., those granted the approval from NIOSH) to designate a shelf life for particulate-only air-purifying respirators (APRs), including FFRs. However, some approval holders have assigned a shelf life to the FFRs that they produce as indicated by product packaging or online reference materials. Additionally, NIOSH minimum performance requirements found within Title 42, Code of Federal Regulations, Part 84 do not require an assessment of fit as part of the evaluation. However, under its Respiratory Protection Standard (29 CFR 1910.134), the Occupational Safety and Health Administration (OSHA) requires employers to fit test any workers using tight-fitting respirators, including FFRs, prior to initial use of the respirator, whenever a different respirator facepiece (size, style, model or make) is used, and at least annually thereafter [OSHA 2021]. OSHA also requires employers to ensure that workers using tight-fitting respirators perform a user seal check each time they put on the respirator [OSHA 2021].
Over the past decade, the Strategic National Stockpile (SNS) and state and local stockpile personnel asked NIOSH to evaluate the effect of stockpile conditions on the viability of respirators. To support this request, NIOSH collected samples of stockpiled N95 FFRs from ten geographically dispersed facilities with varying storage conditions from 2017-2019. Approximately 4,000 FFRs were collected and tested in accordance with NIOSH performance requirements. The facility-specific reports can be found here.
This report details the fit testing performance of N95 FFRs collected from Facility Four which is one of the ten facilities visited. Facility Four is a state stockpile facility.
NIOSH  PPE CASE: Evaluation of Fit and Strap Extension Performance of Stockpiled Filtering Facepiece Respirators from One U.S. Facility. By Greenawald LA, Moore SM, and Yorio PL. Pittsburgh, PA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, NPPTL Report Number P2021-0102.