外来医疗器械压力蒸汽灭菌监测的优化

Optimization of pressure steam sterilization monitoring for loaned instruments

目的在不同灭菌暴露时间程序中,测试外来手术器械灭菌参数和不同灭菌指示物的结果,为合理选择外来手术器械灭菌程序,完善和优化灭菌监测方案提供实践依据。方法134℃分别运行不同暴露时间的灭菌程序,使用温度压力检测仪在器械包内布点并测试灭菌参数,器械包和标准测试包内放置常规化学指示物和延迟灭菌程序化学指示物,包外放置不同种类的PCD监测灭菌效果,对比灭菌参数,评价不同指示物的监测的效果。结果在设定的失败的灭菌参数(1 s、1min)情况下,器械包内维持时间均达不到灭菌要求;六类PCD、管腔PCD、无铅五类卡、延时卡和双五类PCD不合格,而含铅四类卡、爬行卡和综合PCD均合格;灭菌暴露4min程序,棘轮手柄内部达不到灭菌要求,而其他器械达到足够灭菌维持时间;无铅延时卡和双五类PCD不合格;灭菌暴露7min和10min程序,棘轮手柄内部达到灭菌要求,无铅延时卡和双五类PCD也显示合格。结论现有监测手段需要优化,对于常规灭菌程序和升温延迟不明显的器械,应采用代表器械灭菌难度的六类PCD和管腔PCD监测灭菌效果,而对于延长灭菌程序和升温延迟明显的器械,应采用相应的延时卡和双五类PCD监测灭菌效果。

OBJECTIVE To test the results of sterilization parameters and different sterilization indicators of loaned instruments in different sterilization exposure time procedures,and to provide practical basis for reasonable selection of sterilization procedures of loaned instruments,improving and optimizing the sterilization monitoring schemes.METHODS Sterilization procedures were performed at 134 C for different exposure time.Detectors of temperature and pressure were placed inside the instrument pack to test the sterilization parameters.Conventional chemical indicators and extended sterilization procedure chemical indicators were placed inside the instrument pack and standard test pack,and different kinds of PCDs was placed outside the packs to monitor sterilization effect.The monitoring effect of different indicators was evaluated by comparing sterilization parameters.RESULTS When the failed sterilization parameters(1 s,1 min)was set,the maintenance time in the instrument pack could not meet the sterilization requirements.Type 6 PCD,helix PCD,lead-free type 5 cards,extended cards and doubletype-5 PCD were not qualified,while leaded type 4 cards,migration strips and comprehensive PCD are qualified.After sterilization exposure for 4 min,the inside of the ratchet handle could not meet the sterilization requirements,although other instruments reached sufficient sterilization maintenance time,and lead-free extended card and double-type-5 PCD were not qualified.Sterilization exposure for 7 min and 1o min procedures,inside of the ratchet handle achieved the sterilization requirements,and lead-free extended card and double-type-5 PCD also qualified.CONCLUSION The existing monitoring methods need to be optimized.Type 6 PCD and helix PCD can represent the difficulty of instrument sterilization,which can be used to monitor the sterilization effect of some instruments with conventional sterilization procedures and insignificant heating delays.And the other instruments with extended sterilization procedures and obvious heating delays,the corresponding extended card and doubletype-5 PCD should be used to monitor the sterilization effect.