[Surveillance and Analysis of Events Related to the Extended Use of Active Medical Devices: an Empirical Study from the Post-Market Vigilance Perspective].

To examine how post-market vigilance can capture injury signals linked to prolonged use, individual adverse-event reports on active medical devices held by Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring 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.