从不良事件分析报告谈加强医疗器械监管的重要性

Discussion on importance of medical devices monitoring from adverse events analysis reports

目的 :了解医疗器械不良事件监测工作的开展情况、存在问题,提高对不良事件监测重视程度。方法 :结合医院某年度302例医疗器械不良事件统计报告,分析其发生的原因,提出加强医疗器械监管的对策和建议。结果:健全了医疗器械不良事件监测网络,优化了不良事件监测管理体系,提升了监测能力,并通过持续宣传培训,提高了报告质量。结论:只有不断加强重视医疗器械监管,才能有效地提高医疗器械管理水平,保障广大医患用械安全。

Objective To understand the present situation and existing problems of medical device adverse events （MDAE） monitoring and to raise the emphasis on adverse events monitoring.Methods An analysis report on 302 adverse events of some hospital in some year was probed to determine the causes and then propose countermeasures for medical devices monitoring, Results The countermeasures were put forward from the aspects of medical devices adverse events monitoring network, monitoring system, propaganda and training. Conclusion Increased attention to medical device monitoring improves the management, and guarantees the safe use of medical devices.