前瞻性质量管理理念在医疗器械处理中的应用研究  

Research on the Application of Prospective Quality Management Concept in Medical Device Treatment

作　　者：徐洁[1] 高婧颖 XU Jie;GAO Jingying(Disinfection Supply Center,Wuxi No.2 People’s Hospital(Jiangnan University Medical Center),Wuxi Jiangsu 214000,China;Department of Medical Engineering,Wuxi No.2 People’s Hospital(Jiangnan University Medical Center),Wuxi Jiangsu 214000,China)

机构地区：[1]无锡市第二人民医院/江南大学附属中心医院消毒供应中心,江苏无锡214000 [2]无锡市第二人民医院/江南大学附属中心医院医学工程处,江苏无锡214000

出　　处：《中国医疗设备》2025年第3期109-114,共6页China Medical Devices

基　　金：江苏省自然科学基金(BK20191140)。

摘　　要：目的探讨前瞻性质量管理理念干预方案在消毒供应中心(Central Sterilized Supply Department,CSSD)管理中的应用效果。方法随机抽取本院2022年1—6月(前瞻性质量管理实施前)的500包医疗器械,纳入对照组,另取2022年7—12月(前瞻性质量管理实施后)500包医疗器械,纳入研究组。对照组采用传统器械质量管理模式,研究组采用前瞻性质量管理模式,对比2组的医疗器械消毒管理情况、器械质量管理不良事件、器械质量管理质量及临床科室医务人员满意度来验证前瞻性质量管理模式的应用效果。结果研究组的清洗合格率、包装合格率及发放合格率均显著高于对照组,灭菌返消率低于对照组;器械质量管理不良事件发生率显著低于对照组;器械质量管理质量评分显著高于对照组;临床科室医务人员满意度显著高于对照组,以上差异均有统计学意义(P<0.05)。结论前瞻性质量管理理念的引入使得CSSD能够更好地运作,进一步完善CSSD器械质量管理制度,有利于各流程处理合格率的提高。Objective To explore the application effect of prospective quality management concept intervention scheme in the management of central sterilized supply department(CSSD).Methods A total of 500 packages of medical devices from January to June 2022(before the implementation of prospective quality management)were randomly selected to be included in the control group,and another 500 packages of medical devices from July to December 2022(after the implementation of prospective quality management)were selected to be included in the study group.The control group adopted the traditional device quality management mode,while the research group adopted the prospective quality management mode.The application effect of the prospective quality management mode were verified by comparing the medical device disinfection management situation,adverse events of device quality management,device quality management quality and medical staff satisfaction in clinical departments of the two groups.Results The qualified rates of cleaning,packaging and distribution in the study group were significantly higher than those in the control group,and the sterilizing return rate was lower than that in the control group.The incidence of adverse events of device quality management was significantly lower than that of control group.The score of instrument quality management was significantly higher than that of control group.The satisfaction of medical staff in clinical departments was significantly higher than that in control group,and the above differences were statistically significant(P<0.05).Conclusion The introduction of prospective quality management concept enables CSSD to operate better,and further improves the CSSD device quality management system,which is conducive to the improvement of the pass rate of each process.

关 键 词：前瞻性质量管理 消毒供应中心 医疗器械 手术器械 过程管理 器械管理 

分 类 号：R197.3[医药卫生—卫生事业管理]