Cadnum Jennifer L, Pearlmutter Basya S, Li Daniel F, Jencson Annette L, Scott Jacob G, Charnas Ian C, Donskey Curtis J
Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.
Cleveland Clinic Lerner Research Institute, Cleveland, Ohio.
Pathog Immun. 2021 Jun 5;6(1):104-115. doi: 10.20411/pai.v6i1.432. eCollection 2021.
Ultraviolet-C (UV-C) light devices are effective in reducing contamination on N95 filtering facepiece respirators. However, limited information is available on whether UV-C devices meet the Food and Drug Administration's (FDA) microbiological requirements for Emergency Use Authorization (EUA) for respirator bioburden reduction.
We tested the ability of 2 UV-C light boxes to achieve the 3-log microorganism reductions required for EUA for reuse by single users. Whole 3M 1860 or Moldex 1513 respirators were inoculated on the exterior facepiece, interior facepiece, and internal fibers with bacteriophage MS2 and/or 4 strains of bacteria and treated with UV-C cycles of 1 or 20 minutes. Colorimetric indicators were used to assess penetration of UV-C through the respirators.
For 1 UV-C box, a 20-minute treatment achieved the required bioburden reduction for Moldex 1513 but not 3M 1860 respirators. For the second UV-C box, a 1-minute treatment achieved the required bioburden reduction in 4 bacterial strains for the Moldex 1513 respirator. Colorimetric indicators demonstrated penetration of UV-C through all layers of the Moldex 1513 respirator but not the 3M 1860 respirator.
Our findings demonstrate that UV-C box technologies can achieve bioburden reductions required by the FDA for EUA for single users but highlight the potential for variable efficacy for different types of respirators.
紫外线C(UV-C)光设备可有效减少N95过滤式面罩呼吸器上的污染物。然而,关于UV-C设备是否符合美国食品药品监督管理局(FDA)对呼吸器生物负荷降低紧急使用授权(EUA)的微生物要求,目前可用信息有限。
我们测试了2个UV-C灯箱实现EUA要求的单个用户重复使用所需的3对数微生物减少的能力。完整的3M 1860或Moldex 1513呼吸器在外表面、内表面和内部纤维上接种了噬菌体MS2和/或4种细菌菌株,并用1或20分钟的UV-C循环进行处理。使用比色指示剂评估UV-C透过呼吸器的穿透情况。
对于1个UV-C灯箱,20分钟的处理实现了Moldex 1513呼吸器所需的生物负荷降低,但未实现3M 1860呼吸器的生物负荷降低。对于第二个UV-C灯箱,1分钟的处理实现了Moldex 1513呼吸器4种细菌菌株所需的生物负荷降低。比色指示剂显示UV-C穿透了Moldex 1513呼吸器的所有层,但未穿透3M 1860呼吸器。
我们的研究结果表明,UV-C灯箱技术可以实现FDA对单个用户EUA要求的生物负荷降低,但突出了不同类型呼吸器功效可能存在差异的情况。