安全裕量在保障压力蒸汽灭菌器灭菌安全中的应用
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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.
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.
引文
[1]Doornmalen JV,Kopinga K.Review of surface steam sterilization for validation purposes[J].American Journal of Infection Control,2008,36(2):86-92.
[2]张青,张金涛,高宏,等.医用脉动真空高压蒸汽灭菌设备的验证[J].中华医院感染学杂志,2008,18(4):529-531.
[3]Rutala WA,Weber DJ.Disinfection and sterilization:An overview[J].American Journal of Infection Control,2013,41(5):S2-S5.
[4]中华人民共和国卫生部.医院消毒供应中心第三部分:清洗消毒及灭菌效果监测标准[S].北京,2016.
[5]Marcel Dion,Wayne Parker.Steam Sterilization Principles[J].Pharmaceutical Engineering,2013,33(6):1-8.
[6]吴满霞.医院供应室超标敷料包对压力蒸汽灭菌效果的影响[J].中国城乡企业卫生,2017,3(3):147-148.
[7]杨海轶,徐伟雄,李杏华,等.压力蒸汽灭菌法对敷料包灭菌效果研究状况[J].中国消毒学杂志,2011,28(6):755-756.
[8]王艳珍.基层医院消毒供应室湿包形成的原因分析及应对对策[J].世界最新医学信息文摘,2018,18(73):195-196.
[9]Hideharu,Shintani.Validation Study and Routine Control Monitoring of Moist Heat Sterilization Procedures[J].Biocontrol Science,2012,17(2):57-67.
[10]中华人民共和国卫生部.医院消毒供应中心第二部分:清洗消毒及灭菌技术操作[S].北京,2016.
[11]王旭,张剑,张青,等.应用温度压力检测仪对压力蒸汽灭菌程序进行检测分析[J].中国消毒学杂志.2018,35(8):614-615.
[12]陈晨,王欣,庞松涛,等.西安市医疗机构压力蒸汽灭菌器灭菌性能评价[J].中国感染控制杂志,2017,16(3):247-250.
[13]张青,张洋,张凯.压力蒸汽灭菌不同装载方式对灭菌参数的影响[J].中国感染控制杂志,2010,9(6):419-422.
[14]夏春丽,杨海轶.广东省40家医院蒸汽灭菌敷料包管理及灭菌效果物理监测现状分析与对策[J].中国护理管理,2012,12(15):58-60.
[15]姚卓娅,耿军辉,李漫春.压力蒸汽灭菌器常见故障分析及日常维护措施[J].中国消毒学杂志,2018,35(8):624-626.
[16]陈爱琴,郑文,戚维舒,等.广东省部分医疗机构压力蒸汽灭菌器性能监测执行现状调查[J].中国消毒学杂志,2018,35(2):102-104.
[2]张青,张金涛,高宏,等.医用脉动真空高压蒸汽灭菌设备的验证[J].中华医院感染学杂志,2008,18(4):529-531.
[3]Rutala WA,Weber DJ.Disinfection and sterilization:An overview[J].American Journal of Infection Control,2013,41(5):S2-S5.
[4]中华人民共和国卫生部.医院消毒供应中心第三部分:清洗消毒及灭菌效果监测标准[S].北京,2016.
[5]Marcel Dion,Wayne Parker.Steam Sterilization Principles[J].Pharmaceutical Engineering,2013,33(6):1-8.
[6]吴满霞.医院供应室超标敷料包对压力蒸汽灭菌效果的影响[J].中国城乡企业卫生,2017,3(3):147-148.
[7]杨海轶,徐伟雄,李杏华,等.压力蒸汽灭菌法对敷料包灭菌效果研究状况[J].中国消毒学杂志,2011,28(6):755-756.
[8]王艳珍.基层医院消毒供应室湿包形成的原因分析及应对对策[J].世界最新医学信息文摘,2018,18(73):195-196.
[9]Hideharu,Shintani.Validation Study and Routine Control Monitoring of Moist Heat Sterilization Procedures[J].Biocontrol Science,2012,17(2):57-67.
[10]中华人民共和国卫生部.医院消毒供应中心第二部分:清洗消毒及灭菌技术操作[S].北京,2016.
[11]王旭,张剑,张青,等.应用温度压力检测仪对压力蒸汽灭菌程序进行检测分析[J].中国消毒学杂志.2018,35(8):614-615.
[12]陈晨,王欣,庞松涛,等.西安市医疗机构压力蒸汽灭菌器灭菌性能评价[J].中国感染控制杂志,2017,16(3):247-250.
[13]张青,张洋,张凯.压力蒸汽灭菌不同装载方式对灭菌参数的影响[J].中国感染控制杂志,2010,9(6):419-422.
[14]夏春丽,杨海轶.广东省40家医院蒸汽灭菌敷料包管理及灭菌效果物理监测现状分析与对策[J].中国护理管理,2012,12(15):58-60.
[15]姚卓娅,耿军辉,李漫春.压力蒸汽灭菌器常见故障分析及日常维护措施[J].中国消毒学杂志,2018,35(8):624-626.
[16]陈爱琴,郑文,戚维舒,等.广东省部分医疗机构压力蒸汽灭菌器性能监测执行现状调查[J].中国消毒学杂志,2018,35(2):102-104.