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.