Fit Test for N95 Filtering Facepiece Respirators and KF94 Masks for Healthcare Workers: a Prospective Single-center Simulation Study

Abstract

Background For protection against coronavirus disease 2019 (COVID-19), the Korean government recommended the KF94 mask or that a mask at the same level as the KF94 should be worn when contacting a patient with COVID-19. Furthermore, adequately fitted N95 respirators and KF94 masks are essential. We investigated the fit tests to determine whether healthcare workers had adequate protection with N95 respirators and KF94 masks. Methods In this prospective single-center simulation study, five N95 respirators (two made in the USA by 3M and three made in Korea) and six KF94 masks, the Korean standard medical masks, were tested. The fit factor (FF) and leakage rate were evaluated using a two-fit test device. Adequate protection (defined as FF ≥ 100 or leakage rate ≤ 5) rates were compared between N95 respirators and KF94 masks, and between made in Korea and the 3M N95 respirators. For KF94 masks, adequate protection rates were compared before and after ear strap fixation. Results Overall, 30 participants were enrolled, and 330 fit tests were performed for FF and leakage rate. Adequate protection rates of all tested N95 respirators and KF94 masks were 22.7% (n = 75) by FF and 20.6% (n = 68) by leakage rate. N95 respirators showed a significantly higher adequate protection rate than KF94 masks for FF (48.7% vs. 1.1%, P < 0.001) and leakage rate (42.0% vs. 2.8%, P < 0.001). Adequate protection rate of 3M-made N95 respirators was significantly higher than that of those made in Korea (83.3% vs. 25.6% in FF, P < 0.001; 73.3% vs. 21.1% in leakage rate, P < 0.001). In KF94 masks, after fixation of ear strap with a hook, adequate protection rate improved significantly (1.1% vs. 12.8% in FF, P < 0.001; 2.8% vs. 11.1%, P < 0.001). Conclusion Although adequate protection rate of N95 respirators was higher than that of KF94 masks, N95 respirator protection rate was not optimum. Thus, it is necessary to minimize exposure to risk by selecting an appropriate mask or respirator that adequately fits each person, and by wearing respirators or masks appropriately, before contacting the patients. With their superior protection rate, wearing N95 respirators is recommended instead of KF94 masks, especially when performing aerosol-generating procedures.