对住院患者的医疗器械相关危险和不良事件的监测
Matthew H Samore1, R Scott Evans, April Lassen
1University of Utah School of Medicine, Salt Lake City 84132, USA.
JAMA
|January 22, 2004
概括
计算机监控可以识别医疗器械危险和不良医疗器械事件 (AMDEs),但目前的方法效率低. 更密集的监测产生更高的设备问题率,突出显示AMDEs是关键的患者安全问题.
科学领域:
- 医疗器械安全 医疗器械安全
- 医疗信息学 医疗信息学
- 患者安全研究的研究.
背景情况:
- 建立了对药物不良事件的监测.
- 医疗器械错误监测缺乏类似的方法.
- 需要可靠的医疗器械问题检测.
研究的目的:
- 评估计算机监控医疗器械危险和医疗器械不良事件 (AMDE).
- 比较不同的检测设备相关问题的方法.
- 评估各种监控技术的可靠性和效率.
主要方法:
- 在高等教育机构进行描述性研究 (2000年).
- 包括20441名患者 (不包括产科/新生儿).
- 比较计算机标志,遥测检查清单,ICD-9代码,临床工程日志,患者调查和自愿事件报告.
主要成果:
- 7059个计算机标志中的7.8%表示设备危险或AMDE.
- 根据方法,AMDE的发病率有很大的差异 (事件报告:1.6,计算机标志:27.7,ICD-9代码:64.6每1000次入院).
- 方法之间的重叠很低;整体AMDE发病率为每1000例入院中的83.7. 计算机标志的积极预测值在0%至38%之间.
结论:
- 密集监测发现的医疗器械问题比传统报告更多.
- 监控方法之间的重大重叠是最小的.
- AMDEs是一个关键的患者安全问题,需要进一步研究最佳检测策略.
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