1910例可疑医疗器械不良事件报告分析(1)
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【摘要】目的:对1910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:采用回顾性方法,对河南省2009年收集的医疗器械不良事件报告及其质量存在问题进行综合分析。结果:宫内节育器和国家重点监测品种一次性输液器、注射器引起的不良事件所占比例较高。有待进一步提高医疗器械不良事件报告质量。结论:应进一步加强重点品种监测。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。
【关键词】医疗器械;不良事件;分析
The statistical analysis of 1910 adverse events of medical device reports
Sun Lianying Xu Sikang Chen Chao
【Abstract】Objective: To analyse the 1910 reports of medical device adverse events (MDAE) and to provide the suggestions for strengthening MDAE monitoring. Methods: Using the retrospective method, analyse on these reports’s quality problems from Henan province in 2009. Results: The adverse events caused by intrauterine devices (IUD), disposable infusion sets and injectors which is emphasized monitoring species by nation, taking higher proportion. The quality of MDAE reports need to be further improved. Conclusion: Monitoring of key species should be further strengthened ......
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