脉动真空蒸汽灭菌器模拟升温阶段泄漏的灭菌风险研究  

Risk study by fault simulation of entering air at heating-up stage in pulsating vacuum autoclave

作　　者：何惠燕[1] 黄凤玉[1] 吴雪花[1] 李水滔 吴立香 邓杏灵[2] HE Hui-yan;HUANG Feng-yu;WU Xue-hua;LI Shui-tao;WU Li-xiang;DENG Xing-ling(Sun Yat-sen Memorial Hospital Affiliated to Zhongshan University,Guangzhou,Guangdong 510120,China)

机构地区：[1]中山大学孙逸仙纪念医院消毒供应中心,广东广州510120 [2]中山大学中山眼科中心消毒供应中心,广东广州510060

出　　处：《中华医院感染学杂志》2019年第24期3830-3835,共6页Chinese Journal of Nosocomiology

摘　　要：目的通过模拟脉动真空蒸汽灭菌器升温阶段泄漏,研究手术器械的灭菌失败风险,为提高灭菌保障和加强手术器械感染控制提供参考。方法在脉动真空蒸汽灭菌器的空气过滤器进气管上安装球阀,在灭菌程序升温阶段分别人为打开球阀0、5、15和25 s。采用温度压力检测仪测试手术器械包内的灭菌参数,并结合标准测试包测试灭菌器性能参数,手术器械包和标准测试包内分别放置生物指示物和化学指示卡,灭菌器腔体放置不同类型的PCD,同时记录日常物理监测结果。各时间组分别重复实验三次。结果灭菌器升温阶段进入空气0 s时,器械包内部分探头升温延迟,但均可以达到灭菌温度,而其他各项测试均合格;5 s三组测试,器械包内2号探头均达不到灭菌温度,而化学监测和生物监测均合格;15 s三组测试中,2号探头均达不到灭菌温度,六类PCD、标准测试包内的无铅四类卡与无铅五类卡均不合格,标准测试包内生物监测不合格一次;25 s三组测试中,1号和2号探头均达不到灭菌温度,六类PCD、标准测试包内的无铅四类卡与无铅五类卡均不合格,管腔PCD和标准测试包内爬行卡各一次监测不合格。除了进入空气0 s组,灭菌器性能参数测试均不合格。但是各组测试中,物理监测、器械包中心的探头和指示物均合格。结论进入空气的占位效应会造成灭菌失败,但是温度探头和指示物放置在器械包中心无法有效揭示灭菌风险。温度压力检测仪灵敏度较高,可及时发现灭菌失败风险,其次为六类PCD、无铅五类卡与无铅四类卡,值得推广应用于压力蒸汽灭菌监测。OBJECTIVE To study the risk of sterilization failure of surgical instruments by simulating the failure at heating-up stage in pulsating vacuum autoclave and provide reference for improving sterilization protection and strengthening infection control of surgical instruments. METHODS The ball valve was installed on the air filter inlet pipe of the autoclave and was opened for 0, 5, 15 or 25 seconds in four groups respectively during the sterilization process. The temperature and pressure detector device in combination with a standard test package were used to measure the sterilization parameters in the surgical instrument packages. The biological indicators and chemical indicators were both placed in the surgical instrument packages and the standard test packages. Different types of PCDs were placed inside the sterilizer chamber, and the daily physical monitoring results were recorded. The experiment was repeated 3 times for each group. RESULTS When the air enters for 0 seconds during the heating up phase, the time delay of the temperature rising measured by some probes in the instrument package of the sterilizer occurred, but still able to reach the sterilization temperature and all other tests are qualified. The probe No. 2 in the instrument package failed to reach the sterilization temperature in all three 5-second test groups, whereas both chemical monitoring and biological monitoring were qualified. In the 15-second test groups, similarly, the No. 2 probe cannot reach the sterilization temperature in all three test groups. Type 6 PCD and both chemical indicators(Lead-free, Type 4 and 5) in the standard test package were all unqualified, and biological monitoring in the standard test package failed in one test. In the 25-second test groups, the No. 1 and 2 probes failed to reach the sterilization temperature, and Type 6 PCD and both chemical indicators(Lead-free, Type 4 and 5) in the standard test package were unqualified. Helix PCD and the Migration Strip in the standard test package also unqualified in one te

关 键 词：手术器械 灭菌参数 灭菌失败 

分 类 号：R187[医药卫生—流行病学]