环氧乙烷灭菌操作的总结与分析

目的分析8次环氧乙烷气体灭菌操作失败的原因并提出相应处理对策,确保供给临床及相关科室无菌物品的质量。方法通过对两年多来环氧乙烷灭菌操作的观察与记录,从环氧乙烷气体灭菌失败的基本环节入手,查找原因,跟踪调查,制定对策。结果共累计灭菌操作345次,失败8次,失败率约为2.32%,主要原因有物品装载过多,包装方法不规范,清洗后未完全干燥,环境温度因素,突发断电,滤网堵塞等。结论加强护理人员相关知识培训,操作期间必须严格遵守灭菌操作规程及注意事项,密切观察设备运行状况,发现异常情况及时寻找原因并正确处理,是确保环氧乙烷灭菌全过程安全和效果的关键。     

腔镜器械纳入消毒供应中心集中管理的效果分析

目的：探讨腔镜器械纳入消毒供应中心集中管理的模式,保证其清洗、消毒、灭菌质量。方法将腔镜器械纳入消毒供应中心集中规范化管理,通过规范器械相关交接程序,熟悉器械的内部结构,掌握拆卸、装配方法,改进清洗程序等措施加以落实。结果实施集中管理后,腔镜器械清洗合格率由原来的92．7％提高至98．2％;包装合格率由原来的95.0％提高至98．7％;无菌质量合格率由原来的97.0％提高至100.0％。结论腔镜器械由消毒供应中心集中管理后,清洗、包装、灭菌质量得到有效保证,器械保养良好,受到手术相关人员肯定。     

腔镜器械集中清洗与灭菌管理

随着现代科学技术飞速发展和技术引进,越来越多的手术,需要靠精密仪器来辅助完成,腔镜器械就是一大类结构复杂、工艺精细、价格昂贵的仪器设备,其清洗难度大,因此将医院腔镜器械的清洗、包装和灭菌工作纳入消毒供应中心集中清洗与灭菌管理,对使用后各类腔镜进行规范化的处理,提高了器械的清洗灭菌质量与器械的周转率．有效控制了医院内感染,确保了患者安全。     

硬式内镜在消毒供应中心的环节管理

硬式内镜手术器械的种类包括腹腔镜、胸腔镜、关节镜、膀胱镜、宫腔镜等种类繁多,腔镜手术创伤小、痛苦少、住院时间短,目前越来越多的手术采用腔镜技术.我院从2009年开始由消毒供应中心集中管理硬式内镜器械,在回收、清洗消毒、包装、灭菌等环节进行严格管理,保证了器械质量,有效地控制了医院感染的发生.     

洁净手术室腔镜器械管理流程探索

目的：通过规范腔镜器械管理的工作流程,来实现精细化的洁净手术室腔镜器械的管理。方法通过对洁净手术室腔镜器械操作地点的设置并设立专门的与腔镜相关的各种记录本,找出腔镜器械管理中存在的问题,并不断进行改善。结果腔镜器械的管理质量大幅提高,并增加了手术医生、器械护士、巡回护士的满意度。结论通过对腔镜器械规范化管理后,使器械的术前准备、器械发放、术后回收、清洗、灭菌、保养等一系列管理流程更加规范、科学,手术配合工作更加细致、有效,提高了手术效率和护理服务质量。     

STERIS低温灭菌器在腔镜手术中的运用

为了使腔镜器械得到及时有效的消毒灭菌处理,更好地服务于临床,我们自2005年10月来使用了STERIS低温灭菌器,取得了良好的效果. 资料与方法 1.灭菌要求及使用现状根据《内镜清洗消毒技术操作规范(2004年版)》[1]要求,凡进入人体无菌组织、器官或经外科切口进入人体无菌腔室的内镜及附件,如腹腔镜、关节镜、脑室镜、膀胱镜、宫腔镜等必须灭菌.     

层流手术室腔镜器械的流程管理

通过对层流手术室腔镜器械的准备、清洗、灭菌、储存,并设立专门的使用登记本等管理流程,来规范层流手术室腔镜器械的管理,提高了管理质量及手术医生、器械护士的满意度。良好的洁净手术室腔镜器械管理流程,使手术过程更顺利,手术配合工作更规范、科学,提高了手术效率和工作质量。     

PDCA循环在供应室内镜器械清洗消毒管理中的应用效果

目的探讨PDCA循环应用于供应室内镜器械清洗消毒管理中的效果。方法选取2016年1月～2017年1月本院供应室内镜器械采用常规清洗消毒灭菌管理作为对照组;另选取2017年2月～2018年2月采用PDCA循环管理内镜器械清洗消毒灭菌作为研究组。两组均采用简单随机抽样法抽取320件清洗、消毒及包装后内镜器械,比较清洗、灭菌、包装合格率及抽样合格率,同时比较两组工作满意度。结果研究组清洗、灭菌、包装合格率分别为98.44%、99.06%、98.75%,高于对照组的91.88%、90.63%、91.25%,差异有统计学意义(P 0.05);研究组清洗后、包装后无菌合格率及无菌样品合格率分别为97.50%、98.13%、97.81%,高于对照组的90.94%、90.31%、90.63%,差异有统计学意义(P 0.05);研究组工作质量满意度为98.00%,高于对照组的90.00%,差异有统计学意义(P 0.05)。结论在供应室腔镜器械的清洗消毒中实施PDCA循环管理模式,其效果显著,明显提升了腔镜器械的清洗消毒合格率,对减少医源性感染、提高工作质量满意度等方面均具有积极意义,值得应用推广。     

应用STERRAD NX低温等离子灭菌机对胆道镜灭菌效果的评价

目的观察STERRAD NX低温等离子体灭菌机对胆道镜灭菌的可行性及效果评价。方法对胆道镜手术后镜子的清洗、打包、灭菌结果及胆道镜灭菌后性能进行监测。结果使用STERRAD NX低温等离子体灭菌机对胆道镜手术器械灭菌过程化学指示卡与指示胶带变色,工艺监测、生物监测、手术器械灭菌监测均阴性;灭菌后胆道镜的图像清晰、性能完好。结论采用STERRAD NX低温等离子体灭菌机灭菌胆道镜手术器械能够保证灭菌的安全性,对精密的器械损伤小、灭菌时间短,增加了使用周转,提高了手术器械的使用频率,提高了效益,可作为连台胆道镜手术首选的灭菌方法。     

管理模式对内镜消毒灭菌效果影响的调查分析

目的 为了了解某院内镜集中管理前后各种内镜的消毒、灭菌效果,以保证医院内镜消毒与灭菌的质量.方法 依据<内镜清洗消毒技术操作规范>规定,对内镜集中管理前后内镜消毒和灭菌的相关数据进行登记、比较分析.结果 内镜中心成立后,内镜的合格率明显提高.结论 内镜室的建筑布局、清洗消毒设施的配置、工作人员的责任心对内镜的消毒灭菌效果都起着重要的作用.     

医疗器械环氧乙烷灭菌关键质量控制点探析

目的 提高医疗器械环氧乙烷灭菌的安全性和有效性.方法 分析材料的耐受性、灭菌温度、相对湿度、环氧乙烷浓度、作用时间、包装材料等关键质量控制点对医疗器械环氧乙烷灭菌效果的影响.结果 环氧乙烷灭菌材料的适应性较好,适宜的灭菌条件为温度30～60℃,相对湿度40％～80％,环氧乙烷浓度300～1000 mg/L,灭菌时间应至...     

The effect of Gamma and Ethylene Oxide Sterilization on a Selection of Active Pharmaceutical Ingredients for Ophthalmics

Ensuring the sterility of life science products plays a pivotal role in the healthcare sector. Gamma irradiation and ethylene oxide sterilization are two commonly applied methods for the sterilization of medical devices, packaging components and Active Pharmaceutical Ingredients (API) for medicinal products. Focussed studies on the effects of sterilization processes on APIs remain limited. In this research study, five APIs, frequently used in sterile ophthalmic preparations were subjected to both gamma irradiation and ethylene oxide under different process conditions. The following APIs of GMP quality were selected: dexamethasone, aciclovir, tetracycline hydrochloride, triamcinolone and methylprednisolone. Analyses were performed using High Performance Liquid Chromatography equipped with UV detection and the effect of sterilization conditions on the APIs was evaluated by the assay and related substances test prescribed by the European Pharmacopoeia (Ph. Eur.). It was concluded that exposure to ethylene oxide resulted in compliance with Ph. Eur. for all APIs. While dexamethasone and methylprednisolone did not meet the requirement for the Ph. Eur. after exposure to gamma irradiation, the other three APIs did meet the requirement under the specified irradiation conditions. Subsequent optimization of sterilization parameters positively influenced the compliance to the Ph. Eur. requirements.     

Ethylene oxide sterilization and disinfection of plastic articles]

The outline of progress in the use of ethylene oxide sterilization of thermolabile plastic articles is presented. The explosiveness, adsorption and toxicity of the ethylene oxide and the influence of humidity on its bactericidal effectivity are especially emphasized. The methods of checking-up sterilization processes are indicated.     

Sterile packing materials for formaldehyde sterilization

Apart from the already widely applied sterilization by ethylene oxide, the sterilization by gaseous formaldehyde is another reliable procedure for the sterilization of thermolabile instruments. An essential advantage of the sterilization by gaseous formaldehyde over the so-called wet sterilization is that it can be performed in a recontamination-proof sterile packing. Packing materials produced in the GDR, the germ-tightness and toxicological safety of which were already known, were tested to evaluate their suitability for sterilization by gaseous formaldehyde. An appropriate packing variant was found and tested for microbiological reliability.     

Use of ethylene oxide for the sterilization of thermoplastic articles]

The author applied ethylene oxide for sterilization of articles incompatible with thermal sterilization. This method has been widely accepted in many counteries. The tests have been made in the Warsaw Medical School Clinic of Pediatric Surgery, the Polish made "Rotanox" being the source of ethylene oxide. The following items served as sterilizing chambers in this order: Polyethylene foil bags, glass flask and pressurized chambers. The gas pressure of 1 at and temperature of 40-50 degrees C were maintained in the chamber. Sterilized material was closed in the polyethylene foil bags. The effectiveness of this method was proved by bacterial tests.     

医用口罩环氧乙烷残留量实验室快速解析方法改进

目的新型冠状病毒肺炎疫情期间,为加快口罩上市,缩短环氧乙烷的解析时间。方法随机选取10批次按正常灭菌浓度经环氧乙烷灭菌而未进行任何解析处理的医用外科口罩为样本,以气相色谱仪作为检测手段,拆掉样本包装,将样品置超净工作台,在垂直流最大风速情况下,检测不同解析时间环氧乙烷的残留量,对检测结果进行分析。结果与结论通过加大环境空气的流通速度,可使口罩含有的环氧乙烷快速解析,达到标准要求,以合理规避无菌试验前的解析时间,缩短出厂检验周期,加快口罩的上市。     

Exposure of hematopoietic stem cells to ethylene oxide during processing represents a potential carcinogenic risk for transplant recipients

Stem cells for transplantation are obtained from bone marrow, umbilical cord blood, and peripheral blood. A rare complication of hematopoietic stem cell transplantation is donor cell-derived leukemia (DCL). The donors remain cancer free and the causes of these DCL are unknown. Stem cells must repopulate the bone marrow and then give rise to all hematopoietic cells for the rest of the transplant recipient's life. No procedure is acceptable that might introduce precancerous or cancerous mutations in cells performing such a critical function. Medical disposable sets consisting of bags, tubing sets and freezing containers are used to collect, purify and store stem cells. Sterilization of disposables with ethylene oxide is widespread, even though those sets unavoidably retain residual amounts of ethylene oxide which is a potent, direct-acting mutagen and clastogen that has been demonstrated to induce hematopoietic cancer in mice, rats and human beings. Potential exposure levels to ethylene oxide during processing under proposed US FDA guidelines for residual ethylene oxide would be biologically active and present a significant risk factor for DCL. For direct-acting mutagens, there is no recognized "no effect" dose using currently accepted cancer risk assessment models. The safety concerns with ethylene oxide can be eliminated by the use of alternative technologies including electron beam, gamma irradiation, or steam for the sterilization of all products used for stem cell processing and storage.     

Influence of the sterilization process on alginate dispersions

Abstract— The influence of different sterilization procedures on alginate dispersions was studied by measuring viscosity and molecular weight changes. Autoclaving caused a 64% decrease in viscosity. Heating at a low temperature over several cycles was less efficient in sterilizing alginates and there was a progressive breakdown of the alginate chain over the succeeding cycles. Heating during ethylene oxide sterilization also resulted in reduced viscosity and breakdown. Membrane filtration yielded a sterile product with no significant reduction in viscosity or mol. wt.     

Colorimetric quantitative analysis for residual ethylene oxide using 4-(p-nitrobenzyl) pyridine

The aim of this work was to develop an easy and reproducible colorimetric quantitative analysis for residual ethylene oxide after sterilization. The technique proposed is original and uses 4-(p-nitrobenzyl) pyridine. The rapidity and cheapness of the method pleads in favour of its further validation for use with all sterilized medico-surgical equipment.     

The Mount Sinai Hospital's role in the development of anesthesia safety standards

The Department of Anesthesiology of The Mount Sinai Hospital was closely involved in introducing anesthesia safety standards for anesthesia breathing systems, the introduction of the first disposable plastic anesthesia breathing system, the layout of the controls on gas machines, nontoxic airways, safe ethylene oxide sterilization and safe obstetrical anesthesia.