Modifying NIOSH's Manikin Fit Evaluation Method to Match Fit Testing with Human Subjects.

Ali Hasani, Joseph Dawson, Magdalene Fogarasi, Kirstie Snodderly, Daniel Porter, Suvajyoti Guha
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Abstract

A manikin fit test method developed by the Center for Disease Control and Prevention's (CDC) National Institute of Occupational Safety and Health (NIOSH) has been proposed as an alternative to fit testing with human subjects. The advantages of a manikin fit test method over actual fit testing are that it does not require human subjects which can be resource intensive, and hence easier to implement. At the beginning of coronavirus 2019 (COVID-19) pandemic, although early studies showed that manikin fit can be maintained after several decontamination cycles, real world evidence obtained using human subjects revealed that the N95 respirators failed only after a few decontamination cycles. The goal of this article was to make modifications to the NIOSH's manikin fit-test method so it can mimic real world performance of N95 respirators better. After making modifications to this method, we then investigated the effect of long-term wear after donning of the respirators, repeated donning and doffing, as well as decontamination methods (i.e. autoclaving and microwave generated steam) on the fit factor. Averaging the overall manikin fit factor across all scenarios, our modified method overpredicted overall fit factor by only 7 % and 14 % compared to adult human subjects using a breathing routine that included simulated heavy breathing rates of 85, and 70 Liters/minute, respectively. In addition, a constant flow produced similar results as cyclic flow using a breathing simulator. The modified test method also offered the following additional insights into reuse of respirators during future pandemics - when reused within a single work shift, more than 5 donnings should be avoided; and microwave generated steam may be a more viable option for decontaminating N95 respirators compared to autoclaving for a single decontamination cycle.

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修改 NIOSH 的人体模型密合度评估方法,使之与人体密合度测试相匹配。
美国疾病控制与预防中心(CDC)下属的国家职业安全与健康研究所(NIOSH)开发了一种人体模型密合度测试方法,作为人体模型密合度测试的替代方法。与实际的密合度测试相比,人体模型密合度测试方法的优点是不需要人体,而人体测试可能需要大量资源,因此更容易实施。在 2019 年冠状病毒(COVID-19)大流行之初,虽然早期研究表明人体模型密合度可以在几个净化周期后保持不变,但使用人体进行的实际证据表明,N95 呼吸器仅在几个净化周期后就失效了。本文的目的是修改 NIOSH 的人体模型密合度测试方法,使其能够更好地模拟 N95 呼吸器的实际性能。对该方法进行修改后,我们调查了佩戴呼吸器后的长期磨损、反复佩戴和脱下以及去污方法(即高压灭菌和微波产生的蒸汽)对密合度系数的影响。对所有情况下的人体模型总体密合系数进行平均,与使用包括 85 升/分钟和 70 升/分钟模拟大呼吸频率的成人受试者相比,我们改进的方法仅高估了总体密合系数的 7% 和 14%。此外,恒定流量产生的结果与使用呼吸模拟器进行循环流量产生的结果相似。修改后的测试方法还为今后大流行病期间呼吸器的重复使用提供了以下额外的启示--在一个工作班次内重复使用时,应避免超过 5 次;与高压灭菌的单次净化周期相比,微波产生的蒸汽可能是净化 N95 呼吸器的更可行的选择。
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