Fit Assessment of N95 Filtering-Facepiece Respirators in the U.S. Centers for Disease Control and Prevention Strategic National Stockpile.

Michael Bergman, Ziqing Zhuang, Elizabeth Brochu, Andrew Palmiero
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Abstract

National Institute for Occupational Safety and Health (NIOSH)-approved N95 filtering-facepiece respirators (FFR) are currently stockpiled by the U.S. Centers for Disease Control and Prevention (CDC) for emergency deployment to healthcare facilities in the event of a widespread emergency such as an influenza pandemic. This study assessed the fit of N95 FFRs purchased for the CDC Strategic National Stockpile. The study addresses the question of whether the fit achieved by specific respirator sizes relates to facial size categories as defined by two NIOSH fit test panels. Fit test data were analyzed from 229 test subjects who performed a nine-donning fit test on seven N95 FFR models using a quantitative fit test protocol. An initial respirator model selection process was used to determine if the subject could achieve an adequate fit on a particular model; subjects then tested the adequately fitting model for the nine-donning fit test. Only data for models which provided an adequate initial fit (through the model selection process) for a subject were analyzed for this study. For the nine-donning fit test, six of the seven respirator models accommodated the fit of subjects (as indicated by geometric mean fit factor > 100) for not only the intended NIOSH bivariate and PCA panel sizes corresponding to the respirator size, but also for other panel sizes which were tested for each model. The model which showed poor performance may not be accurately represented because only two subjects passed the initial selection criteria to use this model. Findings are supportive of the current selection of facial dimensions for the new NIOSH panels. The various FFR models selected for the CDC Strategic National Stockpile provide a range of sizing options to fit a variety of facial sizes.

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美国疾病控制和预防中心国家战略储备中N95过滤面罩的适用性评估。
美国国家职业安全与健康研究所(NIOSH)批准的N95过滤面罩呼吸器(FFR)目前由美国疾病控制与预防中心(CDC)储备,用于在流感大流行等大范围紧急情况下紧急部署到医疗机构。这项研究评估了为美国疾病控制与预防中心国家战略储备购买的N95 FFR的适用性。该研究解决了特定口罩尺寸所实现的贴合度是否与两个NIOSH贴合度测试小组定义的面部尺寸类别有关的问题。对229名受试者的拟合测试数据进行了分析,这些受试者使用定量拟合测试方案对7个N95 FFR模型进行了九穿拟合测试。最初的呼吸器型号选择过程用于确定受试者是否能够实现对特定型号的充分拟合;然后,受试者测试了九穿合身度测试的合适模型。本研究仅分析了(通过模型选择过程)为受试者提供足够初始拟合的模型数据。对于九个佩戴适合度测试,七个呼吸器模型中的六个不仅适应了与呼吸器尺寸相对应的预期NIOSH双变量和PCA面板尺寸,而且适应了每个模型测试的其他面板尺寸的受试者适合度(如几何平均适配因子>100所示)。表现不佳的模型可能无法准确表示,因为只有两名受试者通过了使用该模型的初始选择标准。研究结果支持目前NIOSH新面板的面部尺寸选择。为美国疾病控制与预防中心国家战略储备选择的各种FFR模型提供了一系列适合各种面部尺寸的尺寸选择。
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