有源器械超期使用事件的监测与分析——基于上市后警戒视角的实证研究

      Surveillance and Analysis of Events Related to the Extended Use of Active Medical Devices —An Empirical Study from the Post-market Vigilance Perspective

      • 摘要: 为探讨上市后警戒如何捕捉超期使用相关伤害信号,筛查上海监测中心有源器械个例不良事件报告数据,对其中明确涉及“超期使用”的报告进行描述性分析、并对典型案例展开剖析。研究发现: 超期相关报告集中于10类器械,占全部超期报告的59.24 %,以电子内窥镜、心电及透析设备居前;共同特征为结构复杂、关键部件不可更换或更换成本高、软件依赖度高。典型案例显示,高频手术导线、高压注射套管、电动吸引器等部件的超寿命使用是导线冒火花、套管爆裂、电动吸引器工作失效等事件的触发因素,并伴随“说明书提示失效、院内维护策略缺位”等系统性缺陷。建议建立“上市后使用期限动态评价”机制,将部件级寿命管理、剩余风险沟通及适时更新说明书纳入闭环管理。

         

        Abstract: To examine how post-market vigilance can capture injury signals linked to prolonged use, individual adverse-event reports on active medical devices held by the Shanghai monitoring center were screened. Reports explicitly mentioning “prolonged/expired use” were analyzed descriptively and key cases were dissected. Results show that 59.24 % of all prolonged-use reports involved ten device types, led by electronic endoscopes, ECG equipment and dialysis machines. Common characteristics include complex architecture, non-replaceable or high-cost key components, and high software dependency. Case studies indicate that the use of high-frequency electrosurgical leads, high-pressure injection tubing, and electric suction units beyond their validated life-span directly precipitates events such as lead arcing, tubing burst, and suction failure, and is accompanied by systemic deficiencies of “obsolete labeling and absent in-hospital maintenance strategies.” A post-market dynamic service-life assessment mechanism is proposed that integrates component-level life-cycle management, residual-risk communication, and timely instruction updating into a closed-loop governance framework.

         

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