The new era of flash sterilization

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FLASH STERILIZATION was developed for use in the OR for emergent need and immediate use of an instrument that was dropped on the floor, forgotten, or unanticipated.

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ISSUES AND CONCERNS regarding flash sterilization practice run the gamut from overuse to misuse to increased risk for infection transmission to increased costs for the health care facility.

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SERIOUS CONSEQUENCES of surgical infection and national demands for patient safety highlight the need for added vigilance in the practices of flash sterilization. Today, state of the art products and equipment can help address some of the challenges historically associated with the flash sterilization process. AORN J 86 (July 2007) 58-68. © AORN, Inc, 2007.

     

Understanding current steam sterilization recommendations and guidelines

PROCESSING SURGICAL INSTRUMENTS in preparation for surgery is a complex multistep practice. It is impractical to culture each and every item to determine sterility; therefore, the best assurance of a sterile product is careful execution of every step in the process coupled with an ongoing quality control program.PERIOPERATIVE STAFF NURSES and managers responsible for instrument processing, whether for a single instrument or multiple sets, must be knowledgeable with regard to cleaning; packaging; cycle selection; and the use of physical, chemical, and biological monitors. Nurses also should be able to resolve issues related to loaner sets, flash sterilization, and extended cycles. AORN J 88 (October 2008) 537-550. © AORN, Inc, 2008.     

Evaluation of closed container flash sterilization system

Flash sterilization is a rapid, effective procedure for providing sterile instruments for surgery; however, aseptic transport of an unwrapped sterile tray is a major problem. This study tested the effectiveness of using a closed container for flash sterilization, and found the closed container to be an effective alternative to the traditional open tray for flash sterilization and transportation of sterile supplies.     

Evaluating use of flash sterilization in the OR with regard to postoperative infections

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THIS ARTICLE DESCRIBES a quality improvement project that examined postoperative infection rates for 100 surgical procedures in which a total of 121 flash sterilizations were performed and determined the costs of treating the postoperative infections compared to the cost of purchasing additional instruments.

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THE POSTOPERATIVE INFECTION rate on physical examination was 3%, and the overall cost of diagnosing and treating the postoperative infections was found to be lower than the cost of purchasing additional instruments.

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TO MINIMIZE USE of flash sterilization, the hospital has added additional surgical instrument inventory and expanded flash sterilization education requirements for staff members. AORN J 83 (March 2006) 672-680.

     

The controversy of flash sterilization

1. Flash sterilization is only recommended for emergency situations because the speed of the process reduces the margin of safety, increases the possibility of trapped air, and requires a high degree of reliability in the sterilizer. 2. When the weight of the instruments is increased, a greater number of organisms may be present and the heat up time of the sterilizer cycle will be longer. 3. If flash sterilization is used, it is important to know the parameters of the unit, how to use it, and how to transport the items so that they are protected from potential air-borne contaminants.     

微生物实验室压力蒸汽灭菌质量控制

目的了解微生物实验室压力蒸汽灭菌效果状况,以提高和保证压力蒸汽灭菌质量。方法采用工艺监测和生物指示剂监测方法,对实验室压力蒸汽灭菌质量进行了验证和监控。结果经对所选择的压力蒸汽灭菌器的灭菌工艺验证,装载容量控制在70%条件下,对盛装于500ml三角烧瓶培养基的灭菌工艺确定为121℃20min。用留点温度计进行252次灭菌温度监测,灭菌温度合格率为100%,化学指示剂监测合格率为98.0%。在设定灭菌温度121℃,作用时间20min,用嗜热脂肪芽孢杆菌芽孢进行15次灭菌效果监测,合格率为100%。结论经过工艺验证,所确定的灭菌条件,可确保压力蒸汽灭菌质量。     

A Hospital-Wide Initiative to Eliminate Preventable Causes of Immediate Use Steam Sterilization

Instruments and implants sterilized by immediate use steam sterilization (IUSS), formerly called flash sterilization, can increase the patient’s risk for acquiring a surgical site infection. We implemented a hospital-wide initiative to determine the reasons that perioperative personnel use IUSS to sterilize items and then designed a program to reduce the hospital’s rates. Program initiatives included educating perioperative personnel, improving scheduling processes, holding vendor discussions, purchasing additional instrument sets, and transitioning from paper wrap to metal containers for instrument sets. In addition, we instituted a policy whereby nursing leaders are required to approve IUSS before it can be used and developed guidelines for immediate and rapid processing in the sterile processing department, and we monitor compliance daily and communicate results regularly to all team members. These efforts decreased our facility use of IUSS for implants from 10.22% in January 2008 to 0.09% in August 2012, and we decreased our use of IUSS for instruments from 79% in May 2010 to 7.5% in February 2012. We simultaneously implemented a process to reduce surgical site infection rates and saw an improvement in surgical site infection from 5.4% in the first quarter of 2010 to 1.4% in the fourth quarter of 2012.     

Efficacy of the pasteur oven as sterilization equipment in dental offices

This study was aimed at assessing the efficacy of the use of the Pasteur oven as sterilization equipment in dental offices through biological monitoring. For this assessment were taken into account how adequately the material is loaded into the equipment; time/temperature used; and preventive maintenance of the oven. The data were collected in 101 dental offices in the Central District of GoiPnia, in the State of Goiás, through observation, interviews and performance of tests with biological indicator. The results showed a lack of standardization of some of the procedures recommended by the Ministry of Health for sterilization of items in the oven, and positive results of the biological test in 46 (45.5%) of the tested cycles. The intervening factors with most significance regarding sterilization problems were: absence of an accessory thermometer to control the cycles' temperature and non-observance of the time/temperature relations recommended for the sterilization cycle through dry heat.     

比较在不同的灭菌时间点生物指示剂与化学指示卡对压力蒸汽灭菌监测的效果

目的 比较3M Attest 1292生物指示荆与3M 1250化学指示卡对压力蒸汽灭菌监测的效果.方法 将2个生物指示剂、2个化学指示卡和1个留点温度计200℃置于标准试验包中心部位,将标准试验包置于134℃脉动真空灭菌器内排气口上方分别作0.5 min、1 min、2 min、3 min、4 min的灭菌后观察结果.结果 生物指示剂在各个时间点的阳性率分别为100%、100%、90%、20%、0%;化学指示卡分别为:100%、90%、10%、0%、0%.结论 3M Attest 1292生物指示剂为压力蒸汽灭菌结果提供了可靠保证的、快速实用的效果监测方法.化学指示剂对灭菌结果监测不够准确但快速.生物指示剂和化学指示剂相辅相成,两者共同使用可以更加准确地监测压力蒸汽灭菌效果.有利于工作的开展.

Abstract：

Objective To compare the monitor effects between the 3M Attest 1292 biological indicator and the 3M 1250 chemical indication cards by autoclave sterilization. Methods Two biological indicators, two chemical indication cards, and one 200 ℃ thermometer were placed in the sterilizer to observe the results after 0. 5 min, 1min, 2 min, 3 min and 4 min sterilization at 134℃ respectively. Results The positive rates of the biological indicators at each time point were 100% , 100% , 90% , 20% ,0% ; those of the chemical indicators were 100%, 90% , 10%, 0%, 0%. Conclusions 3M Attest 1292 biological indicator can provide a more reliable guarantee, fast and practical monitoring methods to the autoclave sterilization. The monitor effect of chemical indicators are not accurate but fast The common use of biological indicators and chemical indication cards can be more accurate for the monitor by autoclave sterilization, and it is conducive to sterilizing work.     

人工股骨体辐射灭菌后遗传和血液相容性研究

目的评价人工关节经辐射灭菌后遗传毒性和血液相容性,探讨辐射灭菌在医用高分子生物材料灭菌中的应用。方法采用ISO11137标准方法检测初始污染菌回收率、校正因子,完成辐照灭菌的剂量设定;对灭菌合格的人工股骨体进行遗传和血液相容性评价。结果人工股骨样品上初始染菌量,需氧菌数平均波动在263~303cfu/件之间,真菌数波动在25~43 cfu/件之间;污染菌回收率范围为92.72%~96.15%。辐照灭菌处理的样品各剂量组与阴性对照组间经统计学检验比较均无显著性差异(P>0.05),未显示出遗传性毒性。经辐照灭菌后样品致溶血率为1.38%,在规定允许范围内。结论设定剂量辐照灭菌后的人工关节遗传和血液相容性好,辐照灭菌作为医用高分子生物材料使用具有良好的安全性。     

不同湿热灭菌方法对凡士林油纱条灭菌效果的影响

目的通过对凡士林油纱条不同方式湿热灭菌后效果的观察,确定其湿热灭菌方式。方法应用内部分层有孔设计的灭菌容器,分别用脉动真空压力蒸汽灭菌与下排汽式灭菌方式进行灭菌,并采用物理、化学、生物三种检测方法对灭菌效果进行观察。结果经过100次常规灭菌程序进行灭菌处理,全部化学指示卡监测合格,生物指示剂全部无菌生长;经过100次下排汽方式灭菌,28次生物监测有菌生长,72次生物监测无菌生长。结论用灭菌盒包装凡士林油纱条,应用下排汽式灭菌柜不能保证灭菌效果,其可以在常规脉动真空压力蒸汽灭菌柜内进行灭菌。     

脉动真空压力蒸汽灭菌器灭菌效果的监测

为了解脉动真空压力蒸汽灭菌器灭菌质量,确保灭菌效果,采用物理、化学、生物方法,对其灭菌质量进行了监测。结果,经监测6480锅次,包内化学指示卡监测合格率达到99.9％;温度监测合格率为99.8％;生物指示剂监测合格率100％。结论,该院脉动真空压力蒸汽灭菌器运行状况良好,物理、化学、生物监测合格率达到99％以上。     

灭菌过程挑战装置监测在口腔器械灭菌中的应用

[目的]观察高压蒸汽灭菌化学监测包内两种化学指示卡及灭菌过程挑战装置（PCD）监测的应用结果。[方法]每个灭菌包内放置3M1250型或1243型化学指示卡,每锅内放置管腔型-化学PCD指示剂,观察灭菌后各指示剂变化结果并记录。[结果]1250型化学指示卡合格率为80%,1243型化学指示卡及管腔型-化学PCD指示剂合格率均为100%。[结论]根据不同包内指示卡的特点及经济成本问题,对非植入物的常规灭菌采用批量管腔型-化学PCD监测;对含植入物的器械灭菌采用1243型包内化学指示卡结合管腔PCD监测。     

低温等离子灭菌器在手术室的应用

目的探讨低温等离子灭菌器在手术室的应用效果。方法选取手术室经低温等离子灭菌的200锅次灭菌物品进行物理、化学及生物指标监测,评估灭菌效果。结果 200锅次操作均1次成功;灭菌处理周期为(62.51±4.64)min;灭菌后化学指示卡变色均合格,生物指示剂培养均无细菌生长。随机抽取30件灭菌物品进行细菌培养提示均无细菌生长。结论低温等离子灭菌器在手术室的应用效果确切。     

医用生物蛋白缝合线灭菌处理方法的研究

目的研究医用生物蛋白缝合线的灭菌处理方法。方法采用载体浸泡定性杀菌试验法和无菌检验技术对低浓度过氧化氢复方消毒剂浸泡灭菌医用生物蛋白缝合线的效果进行了观察。结果用该复方消毒剂处理的缝线在室温条件下存放四年后,其线径平均增大6.40%,抗张强力平均下降7.37%。经多批次无菌试验证实,处理后的产品符合无菌要求。该复方消毒剂原液对染于不锈钢载体上和医用缝合线上的枯草杆菌黑色变种芽孢作用8h,可达到完全杀灭。结论该复方消毒剂具有较强的杀灭细菌芽孢作用,对缝线的性能指标影响较小,可用于医用生物蛋白缝合线的灭菌处理。     

北京市个体医疗机构灭菌质量调查

为了解北京市个体医疗机构的消毒与灭菌质量,采用现场抽检的方法进行了调查。结果,北京市个体医疗机构的压力蒸汽灭菌器配备率为82.3%,城区压力蒸汽灭菌器配备率高于郊区县;全市个体医疗机构的压力蒸汽灭菌器监测频率为每单位每年0.71次;压力蒸汽灭菌器灭菌效果生物监测合格率为68.6%,明显低于全市各级医院生物监测总合格率。针灸针和用于伤口处理的剪刀采用压力蒸汽灭菌器进行灭菌的医疗机构分别占调查单位数的58.1%和82.3%。结论,北京市个体医疗机构压力蒸汽灭菌器配备量不足,压力蒸汽灭菌器监测频率及其合格率偏低;整体灭菌效果有待提高。     

压力蒸汽灭菌用BS-Y型指示剂的研制

<正> 为改进压力蒸汽灭菌监测方法,研制成由嗜热脂肪杆菌芽胞、pH指示培养基与温度指示剂等3部分组成的BS-Y型指示剂。该指示剂用于监测压力蒸汽灭菌,可直接了解是否达到规定温度(121℃),此外经培养后还可根据培养基颜色变化进一步确定灭菌的效果。现将研制结果报告于下。     

压力蒸汽灭菌效果检测专用培养基的研究

目的研究压力蒸汽灭菌效果检测专用培养基,并进行质量观察。方法应用热力灭菌专用生物指示剂直接培养法,对所研制的培养基质量进行了观察和分析。结果 1号批次的培养基的质量分值为18.58≥17.995,为合格培养基。而2号和3号批次的培养基的质量分值分别为16.94和17.89,均<17.995,为不合格培养基。结论第1批次压力蒸汽灭菌效果检测专用培养基用于嗜热脂肪杆菌芽孢生物指示剂灭菌后恢复培养质量较好,不同批次培养基培养质量存在差异,可通过计算分值方法进行质量鉴定后再使用。     

标准化流程在腹腔镜专业器械消毒灭菌中的应用效果

目的观察标准化流程在腹腔镜专业器械消毒灭菌中的应用效果。方法选取本院清洗消毒室应用标准化流程开展腹腔镜器械的消毒灭菌工作,观察应用效果。结果应用标准化流程后,本院腹腔器械灭菌合格率由91.2%提升至96.1%,腹腔镜器械隐血阳性率由39.5%降低至5.7%。结论标准化流程能够提升清洗消毒室的工作效率,提高腹腔镜器械灭菌合格率,降低腹腔镜器械隐血阳性率,值得临床借鉴应用。