压力蒸汽灭菌包内化学指示物对灭菌监测效果的影响

The influence of chemical indicator in pressure steam sterilizing package on sterilization effect monitoring

目的:探讨压力蒸汽灭菌包内化学指示物在经过灭菌过程后所提供的灭菌监测效果的准确性。方法:按照原卫生部2009年12月1日实施的"医院消毒供应中心行业标准",加强灭菌全流程管理,采用问卷调查法、实验法与随机抽样法相结合,将国内医院常用的不同生产厂方的压力蒸汽灭菌包内化学指示物,经过灭菌循环后,比较分析其对灭菌过程的监测效果。同时分析不合格的原因,落实改进措施,提高包内化学指示物对灭菌监测效果的准确率。结果:包内化学指示物的灭菌监测效果与其生产厂方的工艺制作缺陷、包装材料透气性较差、化学指示物直接接触到金属器物、包装过大、灭菌前的装载过满、蒸汽质量欠佳、灭菌器的失误操作及故障运行等密切相关。结论:影响压力蒸汽灭菌包内化学指示物对灭菌监测效果的因素很多,管理者应主动加强灭菌全流程的细节管理,根据手术器械包的风险级别不同,手术器物的结构、材质不同,合理选择合格的包内化学指示物,为灭菌包提供准确的、有价值的监测结果,从而保证无菌物品的质量,确保医疗安全,为医院全面开展优质护理服务保驾护航。

Objective： To explore the accuracy of chemical indicator in pressure steam sterilizing package on monitoring of sterilization effect in sterilization process. Methods： In accordance with the original implementation of Industry Standards of Disinfection and supply Center issued by Ministry of Health on December 1, 2009, we strengthened the management of the whole process of sterilization using the questionnaire survey method, experimental method and random sampling method. We compared the monitoring effect of chemical indicator in sterilization process of different manufacturers commonly used in Chinese hospitals. At the same time, we analyzed the causes of nonconformities, implemented the improvement measures, and improved the package chemical indicator＇s accuracy of monitoring sterilization effect. Results： The effect of sterilization monitoring were associated with production manufacturer defect, packaging materials with poor permeability, direct contact of chemical indicator with the metal utensils, too large package, too full loading before sterilization, unsatisfactory steam quality, sterilizer operation mistake, and failure operation. Conclusion： The sterilization effects of package chemical indicator were influenced by many factors. The managers should take the initiative to strengthen the sterilization process details management, properly select qualified package chemical indicator according to the different risks level, structure of operation objects, different material, and provide accurate and valuable monitoring results for sterilization package to ensure the quality of sterile objects, medical safety, and a comprehensive high quality nursing service.