SteriPro Canada, Inc., Mississauga, Ontario, Canada.
Department of Chemical Engineering, McMaster University, Hamilton, Ontario, Canada.
J Hosp Infect. 2020 Dec;106(4):698-708. doi: 10.1016/j.jhin.2020.09.032. Epub 2020 Oct 2.
Coronavirus disease 2019 (COVID-19) has significantly impacted the health of millions of people around the world. The shortage of personal protective equipment, including N95 respirators, in hospital facilities has put frontline healthcare professionals at high risk for contracting this virus.
To develop a reproducible and safe N95 respirator reprocessing method that satisfies all presented regulatory standards and that can be directly implemented by hospitals using existing available equipment.
A non-toxic gravity steam reprocessing method has been developed for the reuse of N95 respirators consisting of 30 min of steam treatment at 121°C followed by 30 min of heat drying. Samples of model number 1860, 1860s, 1870+, and 9105 N95 respirators were either collected from hospitals (for microbiology testing) or purchased new (for functionality testing), with all functionality tests (i.e. filter efficiency, fit evaluation, and strap integrity) performed at the Centers for Disease Control and Prevention using standard procedures established by the National Institute for Occupational Safety and Health.
All tested models passed the minimum filter efficiency of 95% after three cycles of gravity steam reprocessing. The 1870+ N95 respirator model is the most promising model for reprocessing based on its efficient bacterial inactivation coupled with the maintenance of all other key functional respirator properties after multiple reprocessing steps.
The gravity steam method can effectively reprocess N95 respirators over at least three reprocessing cycles without negatively impacting the functionality requirements set out by regulators. Enabling the reuse of N95 respirators is a crucial tool for managing both the current pandemic and future healthcare crises.
2019 年冠状病毒病(COVID-19)对全球数百万人的健康造成了重大影响。医院设施中包括 N95 呼吸器在内的个人防护设备短缺,使一线医护人员感染该病毒的风险很高。
开发一种可重复使用且安全的 N95 呼吸器再处理方法,该方法满足所有现行监管标准,并且可以由医院使用现有设备直接实施。
已开发出一种无毒重力蒸汽再处理方法,用于重复使用 N95 呼吸器,包括在 121°C 下进行 30 分钟的蒸汽处理,然后进行 30 分钟的热干燥。从医院收集的(用于微生物学测试)或新购买的(用于功能测试)1860、1860s、1870+和 9105 型 N95 呼吸器样本,所有功能测试(即过滤效率、贴合评估和带完整性)均在美国疾病控制与预防中心使用由国家职业安全与健康研究所制定的标准程序进行。
经过三轮重力蒸汽再处理,所有测试型号的过滤效率均超过 95%。1870+N95 呼吸器型号是最有前途的再处理模型,因为它具有高效的细菌灭活能力,并且在经过多次再处理步骤后,所有其他关键的呼吸器性能都得到了保持。
重力蒸汽法可有效地对 N95 呼吸器进行至少三轮再处理,而不会对监管机构规定的功能要求产生负面影响。使 N95 呼吸器能够重复使用是应对当前大流行和未来医疗保健危机的重要工具。