Nakamoto Keitaro, Saraya Takeshi, Kurai Daisuke, Fukukawa Naokatsu, Taneoka Takako, Shimasaki Teppei, Ishii Haruyuki
Respiratory Medicine, Kyorin University School of Medicine, Mitaka, JPN.
General Medicine, Kyorin University School of Medicine, Mitaka, JPN.
Cureus. 2021 Feb 24;13(2):e13542. doi: 10.7759/cureus.13542.
Objectives A surge in the demand for N95 filtering facepiece respirators (N95 respirators) due to the worldwide spread of coronavirus disease 2019 (COVID-19) has resulted in a global shortage of N95 respirators. This study was performed to evaluate the clinical validation of reusing N95 respirators following stringent fit test protocols. Methods After passing the first fit test, we prospectively enrolled healthcare workers who used N95 respirators for two hours per shift (duckbill-shaped HPR-R/HPR-S, dome-shaped Hi-Luck 350, and three-panel flat-fold respirators 9211) in settings such as bronchoscopy or respiratory specimen sampling. These procedures were repeated for up to three weeks, with the fit test performed every week. At each timing of the fit test, we used a fit-testing system for quantitatively evaluating particle leakage. Results A total of 41 participants were enrolled, including 24 doctors and 17 nurses, of whom 25 were women. The pass rate of successful reuse over three observational weeks using four fit tests was 85.4%, which was comparable among the three types of N95 respirators. Six (14.6%) participants failed the fit test, while no participants dropped out of protocol due to either N95 respirator damage or contamination. Among the six dropped out participants, four reused the duckbill-shaped type and two reused the three-panel flat-fold type. All participants using the cup-shaped type mask successfully completed the protocol. However, the passing rate of this study was not statistically different among the three types of N95 respirators. Conclusion This study shows that N95 respirators can be safely reused for a short period irrespective of their type, as quantitatively assessed by fit tests.
目的 由于2019冠状病毒病（COVID-19）在全球范围内传播，对N95过滤式面罩呼吸器（N95呼吸器）的需求激增，导致全球N95呼吸器短缺。本研究旨在评估遵循严格的适合性测试方案重复使用N95呼吸器的临床有效性。方法 在通过首次适合性测试后，我们前瞻性招募了在支气管镜检查或呼吸道标本采样等环境中每班使用N95呼吸器两小时的医护人员（鸭嘴形HPR-R/HPR-S、圆顶形Hi-Luck 350和三层折叠式呼吸器9211）。这些操作重复进行长达三周，每周进行一次适合性测试。在每次适合性测试时，我们使用适合性测试系统定量评估颗粒泄漏情况。结果 共招募了41名参与者，包括24名医生和17名护士，其中25名是女性。使用四次适合性测试在三个观察周内成功重复使用的通过率为85.4%，在三种类型的N95呼吸器中相当。六名（14.6%）参与者适合性测试未通过，而没有参与者因N95呼吸器损坏或污染而退出方案。在六名退出的参与者中，四名重复使用鸭嘴形，两名重复使用三层折叠式。所有使用杯形面罩的参与者均成功完成方案。然而，三种类型的N95呼吸器在本研究中的通过率在统计学上没有差异。结论 本研究表明，通过适合性测试定量评估，无论N95呼吸器的类型如何，均可在短时间内安全重复使用。
