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Proposal for a EN 149 acceptable reprocessing method for FFP2 respirators in times of severe shortage.
Antimicrobial Resistance & Infection Control ( IF 5.5 ) Pub Date : 2020-06-17 , DOI: 10.1186/s13756-020-00744-3
Andreas F Widmer 1 , Gilles Richner 2
Affiliation  

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 H2O2 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. Used FFP2 respirators – Model 3 M Aura™ 1862+ − were sterilized using a low temperature process hydrogen peroxide (H2O2), 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 H2O2. 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. 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. 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.

中文翻译:

建议在严重短缺的情况下为FFP2呼吸器提供EN 149可接受的后处理方法。

将SARS-CoV-2传染给医护人员(HCW)在当前的COVID-19大流行中构成了主要负担。对COVID-19患者的无保护暴露是医护人员的关键危险因素。传播主要通过液滴传播或通过气雾生成程序发生。作为用于HCW的个人防护设备(PPE)的一部分,需要过滤器面罩(FFP2)之类的呼吸器,以防止在气雾生成过程中传播。但是,许多HCW因缺少PPE或无法使用而受到感染。因此,世界范围内呼吸器的短缺促使美国对使用过的FFP2呼吸器或N95呼吸器进行后处理的开发。我们建议使用H2O2等离子体灭菌进行去污,以便对FFP2进行再处理,尽管它们仍然满足EN 149要求的过滤效率。该协议很简单,使用了医院中的可用资源,可以迅速实施以减少危机期间呼吸器短缺的情况。研究的目的是评估呼吸器是否可以再加工,并且仍然满足EN 149概述的过滤效率要求。使用过的FFP2呼吸器– 3 M Aura™1862+型呼吸器使用低温过氧化氢(H2O2)进行了消毒。 ,V-PRO®maX低温,是FDA(食品和药物管理局)批准的对FFP2呼吸器进行消毒的方法。用单气体检测仪检测过氧化氢的呼吸器是否残留过氧化物。根据欧洲标准EN 149,在装有石蜡气雾剂的气氛中,由10名测试人员对防护口罩的总向内泄漏量进行了定量测试。拟合系数计算为总向内泄漏量的倒数。测试了十个新的和十个去污的FFP2呼吸器的过滤效率。没有一个呼吸器超过过氧化物的最大可接受浓度。到目前为止,已经对4000多个呼吸器进行了重新处理,每套的成本约为0.3欧元。FFP2防毒面具在用过氧化物等离子体灭菌消毒后可以安全地进行一次再处理,之后它们仍符合EN 149的要求。这使得目前可用的FFP2呼吸器的数量几乎增加了一倍。将拟合系数计算为总向内泄漏量的倒数。测试了十个新的和十个去污的FFP2呼吸器的过滤效率。没有一个呼吸器超过过氧化物的最大可接受浓度。到目前为止,已经对4000多个呼吸器进行了重新加工,每件的成本约为0.3欧元。FFP2防毒面具在用过氧化物等离子体灭菌消毒后可以安全地进行一次再处理,之后它们仍符合EN 149的要求。这使得目前可用的FFP2呼吸器的数量几乎增加了一倍。将拟合系数计算为总向内泄漏量的倒数。测试了十个新的和十个去污的FFP2呼吸器的过滤效率。没有一个呼吸器超过过氧化物的最大可接受浓度。到目前为止,已经对4000多个呼吸器进行了重新处理,每套的成本约为0.3欧元。FFP2防毒面具在用过氧化物等离子体灭菌消毒后可以安全地进行一次再处理,之后它们仍符合EN 149的要求。这使得目前可用的FFP2呼吸器的数量几乎增加了一倍。成本约为0.3欧元/件。FFP2防毒面具在用过氧化物等离子体灭菌消毒后可以安全地进行一次再处理,之后它们仍符合EN 149的要求。这使得目前可用的FFP2呼吸器的数量几乎增加了一倍。成本约为0.3欧元/件。FFP2防毒面具在用过氧化物等离子体灭菌消毒后可以安全地进行一次再处理,之后它们仍符合EN 149的要求。这使得目前可用的FFP2呼吸器的数量几乎增加了一倍。
更新日期:2020-06-17
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