不同重量器械包的灭菌效果验证及对操作者影响的实验研究

The sterilization effectiveness validation for different weighted surgical instrument packs and experimental research on the impacts on operators

目的观察不同重量器械包的灭菌效果验证及对操作者耐受程度、操作满意度的影响。方法把相同材质的骨科器械按重量分成7kg、9kg、11kg、13KG、15kg、17k、19kg各一组，实验人员用相同的包装材料进行包装，调查实验人员对器械包装重量的可接受程度，同时，在实验包内最难灭菌的部位放置第4类和第5类化学指示卡和生物指示剂。通过标准灭菌循环后，对所有监测结果进行判读，并重复验证灭菌效果。结果器械超过11kg，操作者包装困难，满意度较低；重量7～11kg的器械包用标准程序灭菌，观察化学监测、生物监测为合格；重量超过11kg，使用标准程序灭菌发现化学监测4类指示卡变色不匀，化学监测5类指示卡和生物监测为合格，个别包有湿包现象。结论重量不超过11kg的超重器械包使用标准程序能确保灭菌效果，操作人员满意度较好。

Objective To observe the sterilization effectiveness of different weighted surgical instrument packs and their impacts on operators＇ working satisfaction and acceptance. Method The orthopedic surgical instruments of the same material was divided into 7 categories： 7 kg, 9 kg, 11 kg, 13 kg, 15 kg, 18 kg, 20 kg. The instrument was packed with the same packaging materials by operators, and then investigators evaluated the acceptance of the operators in such procedures. Meanwhile,the investigators put the class 4 and class 5 chemical indicators,as well as biological indicators, at the least favorable position for sterilization within the packs and interpret the monitoring results after standard sterilization cycle to affirm the sterilization performance. Result Instrument packed exceeding 11 kg makes difficult for operator to pack and resulted in lowered satisfaction; instrument pack weighting between 7kg and 11 kg shows pass results in chemical and biological monitoring by using the standard sterilization procedure; pack weight exceeding 11 kg also showed uneven color change in class 4 chemical indicator while class 5 chemical indicator and biological monitoring showing pass results,only with some wet packs. Conclusion Pack weight less than 11 kg can assure tbe sterilization effectiveness in standard sterilization procedure while maintaining good operator satisfaction.