This report summarizes the filtration performance results from the assessments that took place as a result of the initial 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 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. 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 the FDA issued an EUA permitting the use of specified international respirators from seven countries. The United States Occupational Safety and Health Administration (OSHA) issued provisions to permit FFRs approved in these select foreign countries to be temporarily used in the workplace.
While these international respiratory protective devices included in the 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 respirators 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 and other interested parties a point-of-use quantitative assessment of the devices temporarily authorized for use.