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失效模式与效应分析在优化医疗设备验收流程中的应用

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目的 运用失效模式与效应分析(FMEA)优化医疗设备验收流程,提高医疗设备验收质量和效率.方法 组建跨部门、多岗位的FMEA管理团队,利用FMEA分析常规医疗设备验收流程中的高风险流程和失效模式及可能原因,制定针对性流程优化方案.结果 与常规验收流程相比,流程优化后的医疗设备一次验收通过率提高了 36.9%,大型医疗设备验收时间缩短了 19.5 d.结论 应用FMEA能够有效优化医疗设备验收流程、保证医疗设备的使用安全、提升验收质量和效率.
The Application of Failure Mode and Effects Analysis in Optimizing the Acceptance Process of Medical Equipment
Objective To improve the quality and efficiency of medical equipment acceptance,failure mode and effect analysis(FMEA)was used to optimize the medical equipment acceptance process.Methods With the formation of a cross departmental and multi-position FMEA management team,FMEA was utilized to analyze high-risk processes,failure modes,and possible causes in the conventional medical equipment acceptance process to develop targeted process optimization plans.Results Compared with the conventional acceptance process,the one-time acceptance pass rate of medical equipment after process optimization was increased by 36.9%,and the acceptance time of large medical equipment was shortened by 19.5 days.Conclusion The application of FMEA can effectively optimize the acceptance process of medical equipment,ensure the safety of medical equipment use,and improve the quality and efficiency of acceptance.

Failure mode and effect analysisMedical equipmentAcceptance processQuality and efficiency

宋晨、成学慧、隗铁夫

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北京大学肿瘤医院 (北京 100142)

失效模式与效应分析 医疗设备 验收流程 质量和效率

北京大学肿瘤医院课题

312-024-23

2024

医疗装备
国家食品药品监督管理局北京医疗器械质量监督检验中心 北京市医疗器械检验所

医疗装备

影响因子:0.339
ISSN:1002-2376
年,卷(期):2024.37(13)