1900例可疑医疗器械不良事件报告分析

目的对1900例医疗器械不良事件报告进行分析，为加强医疗器械不良事件监测工作提供建议。方法采用回顾性分析方法．对河南省2008年收集的医疗器械不良事件报告及其质量进行综合分析。结果宫内节育器和骨科植入物引起的不良事件所占比例较高。医疗器械不良事件报告质量有待提高。结论应进一步加强宫内节育器和骨科植入器械的重点监测。建议开展宣传培训．进一步推动医疗器械不良事件监测工作．维护公众用械安全。

Statistic Analysis of 1900 Adverse Events of Medical Device Reports

Objective Provide the suggestion for MDAEs monitoring and the reference to strengthen the medical device administration by analyzing the 1900 reports of MDAEs.Method With retrospective case study,analyze 1900 MDAE reports in Henan province in 2008.Result Orthopedic implants and the intrauterine device(IUD)caused the higher proportion of adverse events with serious degree.The scope that the reports covered needs to be raised.Conclusion Further focus monitoring on orthopedic implants and the IUD should be str...