Rengasamy Samy, Niezgoda George, Shaffer Ron
National Institute for Occupational Safety and Health, National Personal Protective Technology Laboratory, Pittsburgh, Pennsylvania 15236.
J Int Soc Respir Prot. 2018;35(1):1-13.
Personal protective equipment (PPE) is worn by workers in surgical settings to protect them and patients. Food and Drug Administration (FDA) clears some PPE (e.g., surgical masks (SM)) as class II medical devices, and regulates some (e.g. surgical head cover) as class I exempt devices. For respiratory protection, National Institute for Occupational Safety and Health (NIOSH)-approved N95 filtering facepiece respirators (FFRs), and powered air-purifying respirators (PAPRs) are used. One type of PPE, "surgical N95 respirators", is a NIOSH-approved FFR that is also cleared by the FDA for use in medical settings. The surgical environment poses unique risks such as the potential for surgical fires. As part of its substantial equivalence determination process, FDA requests testing of flammability and other parameters for SM and surgical N95 respirators. A lack of data regarding flammability of PPE used in healthcare exists. We hypothesize that commonly used PPE, regardless of whether regulated and/or cleared by FDA or not, will pass an industry standard such as the 16 CFR 1610 flammability test.
Eleven N95 FFR models, eight surgical N95 respirator models, seven SM models, five surgical head cover models, and five PAPR hood models were evaluated for flammability with a 45 degree flammability tester using the 16 CFR 1610 method. Three common fabrics were included for comparison.
All of the PPE samples regulated/and or cleared by FDA or not, passed the flammability test at class 1 (normal flammability), meaning they are less likely to burn. Only one of the three common fabrics, a cotton fabric at the lowest basis weight, was class 3 (high flammability).
The results obtained in the study suggest that NIOSH-approved N95 FFRs would likely pass the 16 CFR 1610 flammability standard. Moreover, results suggest that NIOSH is capable of undertaking flammability testing using the 16 CFR 1610 standard as the flammability results NIOSH obtained for N95 FFRs were comparable to the results obtained by a third party independent laboratory.
在手术环境中，工作人员会穿戴个人防护装备（PPE）以保护自己和患者。美国食品药品监督管理局（FDA）将一些个人防护装备（如外科口罩（SM））批准为II类医疗器械，并将一些装备（如外科头罩）监管为I类豁免器械。为进行呼吸防护，使用了美国国家职业安全与健康研究所（NIOSH）批准的N95过滤式面罩呼吸器（FFR）和动力空气净化呼吸器（PAPR）。一种个人防护装备“外科N95呼吸器”是一种经NIOSH批准的FFR，也经FDA批准可在医疗环境中使用。手术环境存在独特风险，如手术火灾的可能性。作为其实质性等同性判定过程的一部分，FDA要求对SM和外科N95呼吸器的可燃性及其他参数进行测试。目前缺乏关于医疗保健中使用的个人防护装备可燃性的数据。我们假设，常用的个人防护装备，无论是否由FDA监管和/或批准，都将通过16 CFR 1610可燃性测试等行业标准。
使用16 CFR 1610方法，通过45度可燃性测试仪对11种N95 FFR型号、8种外科N95呼吸器型号、7种SM型号、5种外科头罩型号和5种PAPR头罩型号进行可燃性评估。纳入三种常见织物进行比较。
所有经FDA监管/和或批准与否的个人防护装备样品均通过了1级（正常可燃性）的可燃性测试，这意味着它们不太可能燃烧。三种常见织物中只有一种，即最低基重的棉织物，属于3级（高可燃性）。
该研究获得的结果表明，经NIOSH批准的N95 FFR可能会通过16 CFR 1610可燃性标准。此外，结果表明NIOSH能够使用16 CFR 1610标准进行可燃性测试，因为NIOSH为N95 FFR获得的可燃性结果与第三方独立实验室获得的结果相当。
