汽化过氧化氢与过氧化氢干雾对比.docx

A Head-to-Head Comparison of Hydrogen Peroxide Vapor and Aerosol Room Decontamination Systems汽化过氧化氢与干雾灭菌系统比较T. Holmdahl, MD,1P. Lanbeck, MD, PhD,1M. Wullt, MD, PhD,1and M. H. Walder, MD, PhD21. Infectious Diseases Unit, Department of Clinical Sciences, Lund University, Malm, Sweden 瑞典伦德大学临床科学系传染疾病组2. Medical Microbiology, Department of Laboratory Medicine, Lund University, Skne University Hospital SUS, Malm, Sweden 瑞典伦德大学医学检验系微生物医学组，瑞典马尔默斯堪大学医院Address correspondence to M. H. Walder, MD, PhD, Klinisk Mikrobiologi Malm, Laboratoriemedicin Skne, SE-20502 Malm, Sweden (mats.waldermed.lu.se).New technologies have emerged in recent years for the disinfection of hospital rooms and equipment that may not be disinfected adequately using conventional methods. There are several hydrogen peroxidebased area decontamination technologies on the market, but no head-to-head studies have been performed.Objective.研究目的： 最近几年，一些新兴技术被用来对医院的房间和传统灭菌方法无法充分灭菌的设备进行灭菌。市场上有几种基于过氧化的区域灭菌技术，但尚没有任何研究来对这些技术进行一一对比。We conducted a head-to-head in vitro comparison of a hydrogen peroxide vapor (HYDROGEN PEROXIDE VAPOUR) system and an aerosolized hydrogen peroxide (aHP) system.研究设计：因此，我们对汽化过氧化氢技术（HYDROGEN PEROXIDE VAPOUR）和过氧化氢干雾扩散技术（aHP）进行了一一对比.The tests were conducted in a purpose-built 136-m3test room.场地：特意建造一个136立方米试验间进行试验One HYDROGEN PEROXIDE VAPOUR generator and 2 aHP machines were used, following recommendations of the manufacturers. Three repeated tests were performed for each system. The microbiological efficacy of the 2 systems was tested using 6-log Tyvek-pouchedMethods.Geobacillus stearothermophilusbiological indicators (BIs). The indicators were placed at 20 locations in the first test and 14 locations in the subsequent 2 tests for each system.测试方法：根据厂商建议，试验中使用一台过氧化氢发生器和2台过氧化氢干雾扩散器。每种技术重复实验三次。用特卫强包装的6-log 嗜热脂肪芽孢杆菌生物指示剂来检验对于微生物的效力。第一轮测试中，生物指示剂（BIs）放置在20个位置；随后的两轮测试均放置于14个位置。All BIs were inactivated for the 3 HYDROGEN PEROXIDE VAPOUR tests, compared with only 10% in the first aHP test and 79% in the other 2 aHP tests. The peak hydrogen peroxide concentration was 338 ppm for HYDROGEN PEROXIDE VAPOUR and 160 ppm for aHP. The total cycle time (including aeration) was 3 and 3.5 hours for the 3 HYDROGEN PEROXIDE VAPOUR tests and the 3 aHP tests, respectively. Monitoring around the perimeter of the enclosure with a handheld sensor during tests of both systems did not identify leakage.测试结果：三轮测试中所有BIs均被汽化过氧化氢（HYDROGEN PEROXIDE VAPOUR）灭活，而干雾过氧化氢扩散器（aHP）在第一轮测试中灭活率为10%，在随后两轮测试中灭活率为79%。汽化过氧化氢的峰值为338ppm, 干雾过氧化氢峰值为160ppm. 整个循环时间（包括通风时间）为，汽化过氧化氢三轮测试为3个小时，干雾过氧化氢三轮测试为3.5个小时。泄漏传感器放置在密闭空间外围，测试中间两个系统均未发现泄漏。One HYDROGEN PEROXIDE VAPOUR generator was more effective than 2 aHP machines for the inactivation of G. stearothermophilusBIs, and cycle times were faster for the HYDROGEN PEROXIDE VAPOUR system.结论: 对于嗜热芽孢杆菌生物指示剂，一台汽化过氧化氢发生器的灭活效力优于两台过氧化氢干雾扩散器，且更省时间。Received January 25, 2011; accepted March 28, 2011; electronically published July 22, 2011收稿日期：2011-01-25， 通过日期：2011-03-28； 电子刊发日期：2011-7-22A recent editorial called for head-to-head studies comparing hydrogen peroxide vapor (HYDROGEN PEROXIDE VAPOUR) and aerosolized hydrogen peroxide (aHP) systems, and, to date, none has been published.1Therefore, we conducted a study to investigate and compare the efficacy of an HYDROGEN PEROXIDE VAPOUR system and an aHP system in terms of their ability to inactivateGeobacillus stearothermophilusbiological indicator (BI) spores distributed around a large single- or dual-occupancy patient room to reflect our intended use.近期，主编希望我们对汽化过氧化氢技术（HYDROGEN PEROXIDE VAPOUR）和干雾过氧化氢（aHP）做一个比较，截至今日，尚未有人发布此类文章。 因此我们对于此两个系统进行了调研，在一间比较大的单人或双人病房，进行嗜热芽孢杆菌的灭活试验。In Skne University Hospital (SUS) Malm, a new infectious disease facility has been built. The facility has 50 standard isolation rooms. These rooms are larger than most single-occupancy hospital rooms and could be used as small double rooms if necessary. In this setting, we are interested in modernizing our hygiene routines and trying new equipment. During the construction phase for our new facility, we built a full-scale mock-up of an isolation room. In this mock-up, new materials and decontamination methods could be tested.瑞典马尔默斯堪大学医院建造了一座新的传染病病区。此病区有50个标准隔离室。这些房间比大多数单人病房都要大，在必要时也可用作双人病房。在此病区，我们很希望尝试一些新的设备来使我们的卫生条例更现代化。 在我们新设施的建设阶段，我们仿造了一间全尺寸的隔离病房。在此仿造病房里，新的材料和新的净化技术可以得到检验。There is now good evidence that contaminated surfaces make a significant contribution to the transmission of nosocomial pathogens, includingClostridium difficile, methicillin-resistantStaphylococcus aureus(MRSA), vancomycin-resistant enterococci (VRE), andAcinetobacter baumannii.2,3Surfaces in patient areas have frequently been found to be contaminated after conventional cleaning,4,5and, linked to these findings, patients admitted to rooms previously occupied by patients positive for VRE, MRSA,A. baumannii, andPseudomonas aeruginosaare at increased risk of acquiring these pathogens.6,7Given these findings, several area decontamination methods have emerged.4,8,9These methods do not rely on the operator to distribute the active substance; thereby, they can achieve coverage of all surfaces in a room and are likely to be more repeatable than conventional methods.有充分证据表明被感染的表面是院内致病菌感染传播的重要因素，包括艰难梭状芽孢杆菌，抗药性金黄色葡萄球菌（MRSA）,耐万古霉素肠球菌（VRE）和鲍氏不动杆菌。 即便在传统方法清洁后，病房表面也经常发现有病菌感染。因此，如果前一个病人上述病菌呈阳性，新病人入住后，会有很大风险感染这些致病菌。根据这些发现，出现了几种新的区域净化方法。这些方法不需要操作人员去喷洒活性物质，就可以覆盖房间内所有表面。并且相对于传统方法来说，更容易重复再现。There are 2 commonly used hydrogen peroxidebased methods on the market, the HYDROGEN PEROXIDE VAPOUR system and the aHP system.1,10These systems have important differences that have been outlined in recent correspondence.10-12The HYDROGEN PEROXIDE VAPOUR system generates HYDROGEN PEROXIDE VAPOUR by adding 35% liquid hydrogen peroxide to a vaporizer heated to 130C. This produces a vapor, which is distributed in the gas phase until it begins to condense on surfaces in the room.4,12After the exposure, an active aeration unit catalyzes the breakdown of HYDROGEN PEROXIDE VAPOUR to oxygen and water vapor. The HYDROGEN PEROXIDE VAPOUR achieves a 6-log reduction on bacterial endospores, includingC. difficile; common hospital bacteria such as MRSA, VRE, andA. baumannii; and viruses.13,14Surface sampling after HYDROGEN PEROXIDE VAPOUR shows that it usually eradicates contamination withC. difficileand other hospital pathogens.12,15Several studies have linked the use of HYDROGEN PEROXIDE VAPOUR with the control of outbreaks,16,17and the use of HYDROGEN PEROXIDE VAPOUR has been shown to reduce the incidence ofC. difficileinfection.12目前市场有两种常用的基于过氧化氢的方法，一种是汽化过氧化氢（HYDROGEN PEROXIDE VAPOUR）,另一种是过氧化氢干雾（aHP）. 这两种方法截然不同。汽化过氧化氢将35% 的过氧化氢液体通过加热至130摄氏度形成蒸汽，气相过氧化氢在空间中扩散。经过曝露后，使用一种活性曝气装置将过氧化氢催化分解成氧气和水。此汽化过氧化氢可以对细菌孢子达到6-log的杀灭率，包括艰难梭菌以及其他医院常见细菌，如MRSA, VRE，鲍氏不动杆菌以及病毒。汽化过氧化氢灭菌后，通过对表面取样显示其可以根除艰难梭菌等医院常见病菌的病原体。 还有些研究也表明在使用汽化过氧化氢对暴发性疫情进行控制时，其可以有效减少艰难梭菌的感染。The aHP system uses pressure to produce an aerosol with a particle size of approximately 810 m from a mixture of 5% hydrogen peroxide, less than 50 ppm silver cations, and less than 50 ppm orthophosphoric acid. After the exposure period, the aerosol is left to decompose passively. The aHP system results in a 4-log reduction ofC. difficilespores and incomplete inactivation in situ.8,18The efficacy of the aHP system against common hospital bacteria such as MRSA andA. baumanniihas to be fully established. The efficacy againstMycobacterium tuberculosisis uncertain.19,20 aHP 过氧化氢干雾使用5%浓度的过氧化氢、50ppm的银离子以及50ppm正磷酸的混合溶液，用压力产生8-10微米的颗粒。曝气后，干雾遗留在空间里被动分解。过氧化氢干雾可以达到4-log的艰难梭菌孢子杀灭率，不能充分灭活。 过氧化氢干雾对于医院常见细菌的效力，如MRSA以及鲍氏不动杆菌，已经得到充分证实。但对于结核杆菌的效力尚未确认。Methods 方法Description of the Test Facility 测试场所描述The tests were conducted in a 136-m3test room in Malm, Sweden. The area was split into 4 rooms: 2 air locks, a main room, and a bathroom. The area had a dedicated air-handling system that extracted to the outside of the building.测试在瑞典马尔默斯堪大学医院136立方米的测试间里进行。此区域被分割成4个房间，2件气闸室，1间主试验室，以及一个洗手间。此区域有专用的通风系统。Biological Indicators 生物指示剂The microbiological efficacy of the 2 systems was tested using 6-log Tyvek-pouchedG. stearothermophilusBIs (Apex Laboratories). The BIs were placed at 20 locations in the first test and 14 locations in the subsequent 2 tests for each system. BIs were located in the main room, the bathroom, the air locks in opposing high and low corner locations, and several challenging locations, such as inside cupboards and drawers, to test the distribution of the systems (seeTable 1for specific BI locations). After exposure to either HYDROGEN PEROXIDE VAPOUR or aHP, the BIs were transferred into tryptone soya broth, incubated, and read according to the manufacturers instructions.测试用BIs是Apex公司的用特卫强Tyvek包装的，6-log嗜热脂肪芽孢杆菌。第一轮测试中，指示剂放置于20个位置，随后两轮测试指示剂放置于14个位置。BIs被放置于主试验室，洗手间以及气闸室的高低对角，以及其他几个位置，比如衣柜里和抽屉里，以便测试系统的分布情况。（具体位置见表1）。 在汽化过氧化氢和干雾过氧化氢曝气后，BIs转移至大豆肉汤里进行培养，然后根据厂商的说明书进行细菌计数。Table 1.Biological Indicator (BI) Location and the Number of BIs Inactivated by the Hydrogen Peroxide Vapor (HYDROGEN PEROXIDE VAPOUR) and Aerosolized Hydrogen Peroxide (aHP) Systems表1 BI位置以及被灭活数量 HYDROGEN PEROXIDE VAPOUR汽化过氧化氢 aHP过氧化氢干雾Test no.123123Main room, top right, near corner主试验室右上，近角+Main room, bottom right, far corner主试验室右下，远角+Main room, top left, far corner主试验室左上，远角+Main room, bottom left, near corner主试验室左下，近角+“In” air lock, top left, near corner进气室，左上近角+“In” air lock, bottom left, far corner进气室，左下远角NDND+NDND“In” air lock, top right, far corner进气室，右上远角NDND+NDND“In” air lock, bottom right, near corner进气室，右下近角NDND+NDND“In” air lock, bottom right, far corner进气室，右下远角NDNDBathroom, top left, near corner洗手间，左上，近角NDND+NDNDBathroom, bottom left, far corner洗手间，左下，远角NDND+NDNDBathroom, top right, far corner洗手间，右上，远角NDND+NDNDBathroom, top left, far corner洗手间，左下，远角NDND+Bathroom, bottom right, near corner洗手间，右下，近角“Out” air lock, top left, near corner排气室，左上，近角NDND+NDND“Out” air lock, bottom left, far corner排气室，左下，远角NDND+NDND“Out air lock, bottom left, near corner排气室，左下近角NDND“Out” air lock, top right, far corner排气室，右上远角+“Out air lock, bottom right, near corner排气室，右下，近角NDND+NDND“Out” air lock, inside cupboard排气室，橱柜内+Main room, inside cupboard主试验室，橱柜内+Back of drawer, open 10 cm 抽屉深处，打开10cmBathroom, underneath washer/disinfector洗手间洗手台下面+Total positive阳性总数0001833No. of BIs指示剂数量201414201414% Positive阳性比率000902121Control 1 阳性对照1+Control 2 阳性对照2+Control 3 阳性对照3+ND=未测试Decontamination Equipment and Configuration 灭菌设备和配置Two aHP machines were used, following recommendations of the manufacturer. The 2 generators were placed in the center of the main room, and external doors were sealed using adhesive tape. The concentration of hydrogen peroxide was measured by a Draegar sensor (Polytron 7000) inside the enclosure. For each of the 3 tests, 3 back-to-back injections of 6 mL/m3hydrogen peroxide were performed. Aeration was assisted using the air-handling system. The test was considered ended when the readings on the handheld sensor were less than or equal to 1 ppm in the air lock and less than or equal to 2 ppm at any point in the room. (The Health and Safety limit for hydrogen peroxide exposure in Sweden is 1 ppm for a working day or 2 ppm for 15-minute period.)21根据厂商建议，2台过氧化氢干雾扩散器放置在主试验室的中心位置，外面的门用胶带密封。使用德尔格 Polytron 7000 放置在室内进行浓度监测。三轮测试的每次测试，均注入3次6mL/m3 过氧化氢溶液。 用通风系统进行辅助扩散。当手持传感器监测到气闸室的浓度小于或等于1ppm，或者房间内任一点浓度小于或等于2ppm时，测试结束。（瑞典规定1ppm的过氧化氢浓度是工作中健康和安全的限值，2ppm浓度下可停留15分钟）One HYDROGEN PEROXIDE VAPOURsuite was used, following recommendations of the manufacturer. The HYDROGEN PEROXIDE VAPOUR generator was placed in the center of the main room, the aeration unit was placed in the doorway of the main room air lock, oscillating pedestal fans were placed in the doorway of the bathroom and the other air lock, and the control pedestal was placed outside the door of the main room. External doors were sealed using adhesive tape, and the handheld sensor was used to monitor for leakage periodically. The concentrations of hydrogen peroxide, temperature, and relative humidity in the room were monitored, and readings were recorded every 5 minutes during the injection phases and regularly during aeration (the removal of HYDROGEN PEROXIDE VAPOUR). For the 3 tests, 900 mL of hydrogen peroxide was injected, with 30 minutes dwell, which equates to approximately 6.6 g/m3. Aeration was assisted using the air-handling system. The test was considered ended when the readings on the handheld sensor were less than or equal to 1 ppm in the air lock and less than or equal to 2 ppm at any point in the room.根据厂商建议，使用1台汽化过氧化氢发生系统进行测试。放置在主试验室正中位置，其通风装置放置在主试验室气闸间的门口。摇头电风扇分别放置于洗手间门口以及另一个气闸室内。操控台放置于主试验室外面，门用胶带密封。手持传感器用于监测泄漏。 室内的过氧化氢浓度，温度以及相对湿度由设备监测。在加药和通风排残期间，每5分钟记录一次数值。三轮测试中，共使用900mL过氧化氢溶液，持续30分钟，相当于6.6g/ m3。测试中使用通风系统进行辅助通风。当气闸室的浓度小于或等于1ppm，或者房间内任一点浓度小于或等于2ppm时，测试结束。Results 结果Data from the HYDROGEN PEROXIDE VAPOUR cycles are presented inFigure 1. The increase and plateau in relative humidity and HYDROGEN PEROXIDE VAPOUR concentration are consistent with the saturation of the air with hydrogen peroxide and subsequent condensation onto surfaces.22The peak hydrogen peroxide concentration was 338 ppm. The total cycle time (including aeration) for the 3 HYDROGEN PEROXIDE VAPOUR tests was 3 hours. All BIs were inactivated in each of the 3 tests (Table 1).汽化过氧化氢（HYDROGEN PEROXIDE VAPOUR）数据参看图1, 随着相对湿度和浓度的增加以及稳定,空气中的过氧化氢达到饱和并凝结在表面。 过氧化氢的峰值是338ppm. 三轮测试总的循环时间（包括通风排残）为3小时。三轮测试中，每次测试BIs都被完全灭活。Figure 1.Cycle data from 3 hydrogen peroxide vapor cycles. Aggregate data from 3 repeat cycles; error bars represent 1 SD 图1. 三轮汽化过氧化氢循环灭菌数据。数据集合来自于3次试验，误差范围1标准差循环时间/分钟过氧化氢浓度温度/相对湿度The hydrogen peroxide concentration from the aHP tests is presented inFigure 2. The tests were performed sequentially on the same day, and it appears that there was an accumulation of hydrogen peroxide in the enclosure because the peak hydrogen peroxide concentration increased from less than 100 ppm in the first test to approximately 130 ppm in the second test and to greater than 150 ppm in the third test. Ten percent of BIs were inactivated in the first test, compared with 79% in the second and third tests (Table 1). Total cycle times were approximately 3.5 hours.过氧化氢干雾测试的浓度见图2. 测试在同一天依次进行，所以浓度有累积现象。因为第一轮测试中过氧化氢的峰值小于100ppm, 第二轮测试中峰值约为130ppm，而到了第三轮峰值为150ppm。 第一轮测试中，10%的生物指示剂被灭活，而第二轮和第三轮测试中79%的生物指示剂被灭活（参看表1）。 总的循环时间约为3.5小时。Figure 2.Hydrogen peroxide concentration from the 3 aerosolized hydrogen peroxide tests.图2. 三轮过氧化氢干雾测试浓度时间段过氧化氢浓度Monitoring around the perimeter of the enclosure with a handheld sensor during tests did not identify leakage for either system.密闭空间外围的传感器未监测到系统有泄漏。Discussion 探讨Hydrogen peroxide is a potent disinfectant and sterilant that penetrates the bacterial cell wall by passive diffusion and then acts by denaturing proteins, DNA, and other components inside the bacterial cell.23It is not harmful to the environment because it breaks down to water and oxygen, leaving no toxic by-products. We consider hydrogen peroxide decontamination an important method in terminal disinfection of rooms previously occupied by patients positive for MRSA, VRE,Acinetobacterspp.,C. difficile, or other problem bacteria.过氧化氢是一种强效消毒和杀菌剂，它可以通过被动扩散渗透入细胞壁，然后使蛋白质、DNA以及细菌细胞中其他部分变性。它能分解成氧气和水，对环境无害，也没有有毒副产品。我们认为过氧化氢灭菌是一项非常重要的空间灭菌方法，可以为杀灭病房的MRSA, VRE, 不动杆菌属种,艰难梭菌或其他细菌We tested 2 different types of hydrogen peroxidebased whole-room decontamination systems. The main difference between the 2 technologies is the formation of the HYDROGEN PEROXIDE VAPOUR or aerosol. HYDROGEN PEROXIDE VAPOUR creates a vapor in gaseous form from 35% w/w hydrogen peroxide, whereas aHP creates an aerosol from 5% hydrogen peroxide, with drops of 810 m. The aHP aerosol is stabilized using silver ions and other chemicals to avoid aggregation before the drops reach the target. Other differences between the 2 systems are the peak hydrogen peroxide concentration, which is twice as high in HYDROGEN PEROXIDE VAPOUR as in aHP, and the total hydrogen peroxide concentration (measured as area under the curve), which is higher for HYDROGEN PEROXIDE VAPOUR.我们测试了两种基于过氧化氢的空间灭菌技术。两种技术的主要区别在于形成机制的不同，汽化过氧化氢技术（HYDROGEN PEROXIDE VAPOUR）将35%的过氧化氢溶液转变为气相。而过氧化氢干雾技术(aHP)将5%浓度的过氧化氢混合液雾化成8-10微米的液滴。并采用银离子和其他化学品作为稳定剂，以防止液滴在达到目标位置之前凝聚。另外一个不同就是，过氧化氢峰值浓度，汽化过氧化氢的峰值浓度是过氧化氢干雾的两倍。而且汽化过氧化氢总的浓度也高于过氧化氢干雾Bacterial endospore BIs are typically used to monitor the effectiveness of sterilization and high-level disinfection procedures, such as autoclaves and vapor-phase decontamination methods.24In our study, the HYDROGEN PEROXIDE VAPOUR system inactivated BIs at all locations in each of the 3 tests, suggesting a homogenous and repeatable distribution. BIs are used routinely to monitor HYDROGEN PEROXIDE VAPOUR decontamination systems.4,12,22生物指示剂经常被用来监测消毒以及更高级别灭菌的效果，比如高压蒸汽灭菌和汽化灭菌方法。在我们的研究中，汽化过氧化氢对于三轮测试中所有位置的生物指示剂均能灭活。生物指示剂被用于监测常规的过氧化氢灭菌。Several studies have used BIs to monitor aHP systems. After 3 back-to-back cycles, 13% of 146 BIs grew in hospital rooms in 1 study, although 3 cycles inactivated all BIs in separate experiments in 22 rooms in a surgery department and inside ambulances.25In this study, 1 or 2 cycles had little impact on the BIs. Therefore, we chose to use 3 back-to-back cycles for each test of the aHP machine. However, even after 3 back-to-back cycles were used, the aHP system inactivated o