PPE CASE - Filtration Efficiency Performance of Non-NIOSH-Approved International Respiratory Protective Devices: Phase Two
NPPTL Report Number P2020-0113
National Institute for Occupational Safety and Health
National Personal Protective Technology Laboratory
This report summarizes the filtration performance results from the assessments that took place as a result of an Emergency Use Authorization (EUA) issued by the United States Food and Drug Administration (FDA) and discusses important considerations when purchasing non-NIOSH-approved international respiratory protective devices temporarily authorized for occupational use in the United States.
In order to supplement the national inventory of N95 filtering facepiece respirators (FFRs) and increase the supply of available respirators, the National Institute for Occupational Safety and Health (NIOSH), part of the Centers for Disease Control and Prevention (CDC), suggested several strategies to optimize the supply of N95 respirators (CDC 2020). These guidelines include strategies for crisis capacity—those used when there is a shortage of NIOSH-approved respirators. Included within this set of strategies is the provision for the use of non-NIOSH-approved international respiratory protective devices that were manufactured under foreign standards but that incorporate performance requirements similar to NIOSH-approved N95 FFRs.
Consistent with these guidelines, in March 2020, FDA issued an EUA permitting the use of specified international respirators from seven countries (FDA 2020external icon). The United States Occupational Safety and Health Administration (OSHA) issued provisions to permit FFRs approved in these select countries to be temporarily used in the workplace (OSHA 2020external icon).
While these international respiratory protective devices included in FDA’s EUA and OSHA’s enforcement guidelines have similar performance requirements compared with NIOSH-approved devices, NIOSH does not oversee the initial production, regulate sustained manufacturer quality control for these products, monitor post-market quality, or have knowledge about the product’s handling and exposures after leaving the manufacturer’s control. Due to the potential to have these non-NIOSH-approved international respiratory protective devices used by workers in the United States, NIOSH designed a process to assess the particulate filtration performance. The goal of the assessment was to provide consumers of personal respiratory protection devices and other interested parties a point-of-use quantitative assessment of the devices temporarily authorized for use.
As reported in the Phase One PPE CASE report (NPPTL Report Number P2020-0112), NIOSH completed 105 assessments of non-NIOSH-approved international respiratory protective devices from the start of the FDA EUA April 10, 2020 through May 6, 2020. This PPE CASE report (Phase Two) provides the results of 251 NIOSH assessments of non-NIOSH-approved international respiratory protective devices conducted from May 7 through August 17, 2020.
NIOSH  PPE CASE: Filtration efficiency performance of non-NIOSH-approved international respiratory protective devices: phase two. Andrews A, Powers J, Cichowicz J, Coffey C, Fries ML, Yorio PL, D’Alessandro M. 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 P2020-0113.