安全裕量在保障压力蒸汽灭菌器灭菌安全中的应用  

Application of Safety Margin in Ensuring Sterilization Safety of Pressure Steam Sterilizer

作　　者：郝淑芹[1] 张一艳[1] 肖婉静[1] 刘丛[1] 陈海燕 徐伟雄 HAO Shu-qin;ZHANG Yi-yan;XIAO Wan-jing;LIU Cong;CHEN Hai-yan;XU Wei-xiong(Shenzhen Second People's Hospital Guangdong Shenzhen 518035;Belimed Medical Equipment (Shanghai) Co.,Ltd.,Shanghai 200443)

机构地区：[1]深圳市第二人民医院,广东深圳518035 [2]倍力曼医疗设备(上海)有限公司,上海200443

出　　处：《深圳中西医结合杂志》2019年第10期26-28,共3页Shenzhen Journal of Integrated Traditional Chinese and Western Medicine

基　　金：深圳市科技计划项目资助课题(CYJ2013401111618886)

摘　　要：目的:确定压力蒸汽灭菌器正常运行的安全裕量。方法:在压力蒸汽灭菌器正常运行范围内,进行50次实验,测定灭菌器关键参数(平衡时间、灭菌温度范围、维持时间、温度均匀性)结果,归纳出安全裕量。结果:关键参数的安全裕量重现性良好。结论:实现量化评价压力蒸汽灭菌过程,能通过风险分析规避灭菌失败可能事件,提早进行干预性维护;发现物理监测、化学监测、生物监测未能发现的敷料未经清洗重复使用、管腔堵塞问题,保证灭菌安全。Objective Obtaining the safety margin of pressure steam sterilization. Methods In the normal operation range of pressure steam sterilizer, 50 experiments were carried out to determine the key parameters(equilibration time, sterilization temperature band, holding time, and sterilization temperature uniformity) of the sterilizer, and the safety margin value was calculated therefore. Results The key parameters remain good reproducibility. Conclusion Quantitative evaluation of pressure steam sterilization process can be realized by risk analysis to avoid possible events of sterilization failure, and performance of early intervention maintenance of pressure steam sterilizer. Realization of discovering problems of dressing reuse without cleaning and tube blockage by safety margin, which cannot be found by physical monitoring, chemical monitoring and biological monitoring.

关 键 词：压力蒸汽灭菌器 安全裕量 安全性能 

分 类 号：R197.39[医药卫生—卫生事业管理]