Health care workers and respiratory protection: is the user seal check a surrogate for respirator fit-testing?

Many agencies recommend that health care workers wear N95 filtering facepiece respirators (N95-FFR) to minimize occupational exposure to bioaerosols, such as tuberculosis and pandemic influenza. Published standards outline procedures for the proper selection of an N95-FFR model, including user seal checks and respirator fit-testing. Some health officials have argued that the respirator fit-test step should be eliminated altogether, given its additional time and cost factors, and that only a user seal check be utilized to ensure that an adequate face seal has been achieved. One of the aims of the current study is to examine whether a user seal check is an appropriate surrogate for respirator fit-testing. Subjects were assigned an N95-FFR and asked to perform a user seal check (as per manufacturer's instructions) after which they immediately underwent a respirator fit-test. Successfully passing a respirator fit-test was based on not detecting a leakage through the face seal (either qualitatively with a test agent or quantitatively with a particulate counter). The sample population consisted of 647 subjects who had never been previously fit-tested (naive), while the remaining 137 participants were experienced respirator users. Only four of the 647 naive subjects (0.62%) identified an inadequate seal during their user seal check. Of the 643 remaining naive subjects who indicated that they had an adequate face seal prior to fit-testing, 158 (25%) failed the subsequent quantitative fit-test and 92 (14%) failed the qualitative fit-test. All 137 experienced users indicated that they had an adequate seal after performing the user seal check; however, 41 (30%) failed the subsequent quantitative fit-test, and 30 (22%) failed the qualitative fit-test. These findings contradict the argument to eliminate fit-testing and rely strictly on a user seal check to evaluate face seal.