人工心脏起搏器和冠状动脉介入诊治常用器械不良事件专项监测结果分析

Analysis of Special Monitoring for Medical Device Adverse Events of Artificial Cardiac Pacemaker and Percutaneous Coronary Intervention

为了更好地了解人工心脏起搏器和冠状动脉介入诊治常用器械的使用及安全性情况,从2006年开始,北京市药品评价中心对这两类高风险植入类医疗器械开展专项监测。通过19个月专项监测工作,初步掌握了北京市这两类医疗器械的使用现状和不良事件发生情况,为深入开展医疗器械监测工作提供了有意义的启示。

In order to understand status of the use and safety of artificial cardiac pacemaker and percutaneous coronary intervention （PCI）, we carried out special monitoring for these medical devices from 2006 to 2007. We have mastered the condition of the use and adverse events of these medical devices in Beijing by special monitoring. This has provided the meaningful apocalypse for promoting medical device adverse event monitoring.