摘要
目的:将医疗失效模式和效应分析(HFMEA)用于医院手术室高值医用耗材的温度管理,以优化管理流程、提高管理质量。方法:成立医用耗材温度管理研究小组。运用HFMEA方法识别高值耗材温度管理全流程中的失效模式,计算风险优先数(RPN),确定9项高风险失效模式并提出改进措施。选取2023年1月至2024年12月江苏省中医院北院手术室在用的高值医用耗材。2023年1月至12月的206件采用常规管理模式,2024年1月至12月的1098件应用HFMEA管理模式,比较两种管理模式下的高风险失效模式RPN值、高值医用耗材验收合格率和不良事件发生率。结果:HFMEA管理模式下的9项高风险失效模式RPN值均显著下降,差异有统计学意义(t=10.875、5.75、5.854、8.899、8.553、5.059、11.29、7.114、6.313,P<0.05)。HFMEA管理模式下的高值医用耗材验收合格率为96.36%,高于常规管理模式的82.04%,与常规管理模式比较,差异有统计学意义(χ^(2)=76.21,P<0.05)。耗材不良事件发生率由1.78%降至0(Fisher精确检验,P<0.05)。结论:将HFMEA用于医院手术室高值医用耗材的储运温度管理,可有效降低温度管理中的风险,提高管理质量。
Objective:To apply Healthcare Failure Mode and Effects Analysis(HFMEA)to the temperature management of highvalue medical consumables in hospital operating rooms,so as to optimize the management process and improve management quality.Methods:A research team dedicated to the temperature management of medical consumables was established.The HFMEA method was adopted to identify failure modes throughout the entire temperature management process of high-value medical consumables,calculate the Risk Priority Number(RPN),identify 9 high-risk failure modes,and formulate corresponding improvement measures.High-value medical consumables used in the operating rooms of the North Branch of Jiangsu Provincial Hospital of Chinese Medicine from January 2023 to December 2024 were selected as the research objects.A total of 206 consumables from January to December 2023 were managed under the conventional mode,while 1,098 consumables from January to December 2024 were managed under the HFMEA-based mode.The RPN values of high-risk failure modes,acceptance qualification rate of high-value medical consumables,and incidence of adverse events were compared between the two management modes.Results:The RPN values of all 9 high-risk failure modes under the HFMEA management mode decreased significantly,with statistically significant differences(t=10.875,5.75,5.854,8.899,8.553,5.059,11.29,7.114,6.313,P<0.05).The acceptance qualification rate of highvalue medical consumables under the HFMEA mode reached 96.36%,which was significantly higher than the 82.04%under the conventional mode,with a statistically significant difference(χ^(2)=76.21,P<0.05).The incidence of consumable-related adverse events decreased from 1.78%to 0(Fisher's exact test,P<0.05).Conclusion:The application of HFMEA in the storage and transportation temperature management of high-value medical consumables in hospital operating rooms can effectively reduce risks in temperature management and significantly improve the overall management quality.
作者
顾燕
于健伟
陈伟伟
Gu Yan;Yu Jianwei;Chen Weiwei(Center of Procurement and Distribution,Jiangsu Province Hospital of Chinese Medicine,Nanjing 210029,China;Department of Clinical Medical Engineering,Jiangsu Province Hospital,Nanjing 210029,China)
出处
《中国医学装备》
2025年第12期168-172,共5页
China Medical Equipment
关键词
医疗失效模式和效应分析(HFMEA)
高值医用耗材
耗材管理
储运
温度管理
Healthcare Failure Mode and Effects Analysis(HFMEA)
High-value medical consumables
Consumable management
Storage and transportation
Temperature management
