严重短缺时期，FFP2 呼吸器的 EN 149 可接受再处理方法提案。
Proposal for a EN 149 acceptable reprocessing method for FFP2 respirators in times of severe shortage.
机构信息
University of Basel Hospitals, Division of infectious Diseases & Hospital Epidemiology and University of Basel, 4031, Basel, Switzerland.
Federal Office for Civil Protection FOCP, Spiez Laboratory, Spiez, Switzerland.
出版信息
Antimicrob Resist Infect Control. 2020 Jun 17;9(1):88. doi: 10.1186/s13756-020-00744-3.
INTRODUCTION
Transmission of SARS-CoV-2 to health care workers (HCW) poses a major burden in the current COVID-19 pandemic. Unprotected exposure to a COVID-19 patient is a key risk factor for HCWs. Transmission mainly occurs by droplet transmission, or by aerosol generating procedures. Respirators such as filtering face piece masks (FFP2), also called respirators, are required to prevent transmission during aerosol generating procedures, as part of the personal protective equipment (PPE) for HCWs. However, many HCW were infected due to lack of PPE, or failure to use them. Therefore, the worldwide shortage of respirators triggered the development of reprocessing used FFP2 respirators or N95 respirators as standard in the US. Our proposal with HO plasma sterilization for decontamination allows to reprocess FFP2, while they still meet the filtration efficiency required by EN 149. The protocol is simple, uses available resources in hospitals and can be rapidly implemented to decrease the shortage of respirators during this crisis. The goal of the study was the evaluate if respirators can be reprocessed and still fulfill the requirements for filtration efficiency outlined by EN 149.
METHODS
Used FFP2 respirators - Model 3 M Aura™ 1862+ - were sterilized using a low temperature process hydrogen peroxide (HO), V-PRO® maX Low Temperature, a FDA (Food and Drug Administration) approved method to decontaminate FFP2 respirators. Decontaminated respirators were further checked for residual peroxide by a single-gas detector for HO. The total inward leakage of the protective respirators was quantitatively tested with 10 test persons in an atmosphere charged with paraffin aerosol according to the European Standard EN 149. The fit factor was calculated as the inverse of the total inward leakage.
RESULTS
Ten new and ten decontaminated FFP2 respirators were tested for filtration efficiency. None of the respirators exceeded the maximum acceptable concentration of peroxide. More than 4000 respirators have been reprocessed so far, at cost of approximately 0.3 Euro/piece.
CONCLUSIONS
FFP2 respirators can be safely reprocessed once after decontamination with plasma peroxide sterilization, whereafter they still fulfill EN 149 requirements. This allows to almost double the current number of available FFP2 respirators.
简介
SARS-CoV-2 向医护人员（HCW）的传播在当前的 COVID-19 大流行中构成了重大负担。未受保护地接触 COVID-19 患者是 HCW 的关键危险因素。传播主要通过飞沫传播，或通过产生气溶胶的程序进行。在产生气溶胶的程序中，需要使用呼吸器（例如过滤式面罩（FFP2），也称为呼吸器）来防止传播，这是 HCW 个人防护设备（PPE）的一部分。但是，由于缺乏 PPE 或未能使用 PPE，许多 HCW 被感染。因此，全球范围内呼吸器短缺促使美国开发了对再处理的使用过的 FFP2 呼吸器或 N95 呼吸器作为标准。我们使用 HO 等离子体灭菌进行消毒的建议允许再处理 FFP2，同时它们仍满足 EN 149 要求的过滤效率。该方案简单，利用医院中现有的资源，并可以迅速实施，以减少危机期间呼吸器的短缺。该研究的目的是评估呼吸器是否可以进行再处理，并且仍满足 EN 149 概述的过滤效率要求。
方法
使用过的 FFP2 呼吸器 - 3M AuraTM 1862+型号 - 使用低温过程过氧化氢（HO），V-PRO®maX 低温进行灭菌，这是一种经美国食品和药物管理局（FDA）批准的方法，可对 FFP2 呼吸器进行消毒。用单气体探测器检查经消毒的呼吸器中是否残留过氧化氢。根据欧洲标准 EN 149，用 10 名测试人员在充满石蜡气溶胶的气氛中对防护呼吸器的总向内泄漏进行定量测试。拟合因子被计算为总向内泄漏的倒数。
结果
对十个新的和十个经消毒的 FFP2 呼吸器进行了过滤效率测试。没有一个呼吸器的过氧化物浓度超过最大允许浓度。迄今为止，已经对 4000 多个呼吸器进行了再处理，成本约为每个 0.3 欧元。
结论
FFP2 呼吸器可以在使用等离子体过氧化物灭菌进行消毒后安全地再处理一次，此后它们仍符合 EN 149 的要求。这使得当前可用的 FFP2 呼吸器数量几乎增加了一倍。
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