在FDA制造商和用户设施设备体验 (MAUDE) 数据库中对囊内镜事件的描述性分析
Hangyu Ji1, Shaoli Wang1, Yang Gong2
1China Academy of Chinese Medical Sciences Guang'anmen Hospital, Beijing, People's Republic of China.
Journal of digestive endoscopy
|May 21, 2024
概括
囊内镜 (CE) 装置的故障是程序失败的关键原因. 分析制造商和用户设施设备体验 (MAUDE) 报告揭示了对这些不良事件的关键见解,改善了患者的安全.
科学领域:
- 胃肠病学 胃肠病学
- 医疗器械安全 医疗器械安全
- 医疗信息学 医疗信息学
背景情况:
- 囊内镜 (CE) 装置的故障显著影响诊断程序的成功.
- 在文献中,CE设备的故障相关不良事件 (AE) 报告不足.
- 这些AE可能会降低医疗保健的效率并增加成本,尽管它们并不总是直接造成身体伤害.
研究的目的:
- 识别和分析与囊内镜 (CE) 设备相关的不良事件 (AE).
- 证明制造商和用户设施设备体验 (MAUDE) 数据库报告的实用性,以提高CE程序中的患者安全.
主要方法:
- 从2008年1月到2020年7月对CE系统的MAUDE报告进行系统搜索.
- 医疗器械报告的提取和手动审查,包括结构化数据和叙事文本.
- 对设备类型,事件类型,报告员职业,患者结果和AE分类的分析.
主要成果:
- 分析了342份MAUDE报告,确定了349个与CE相关的AE.
- 与故障相关的AE占总AE的109,在不同类型的设备中存在差异.
- 对囊内镜和透视囊来说,并发症是主要的副作用,而传感系统和输送设备的故障占主导地位.
结论:
- 马德数据库是研究CE设备故障相关的AE的宝贵资源.
- 意识和员工培训对于预防胃肠内镜装置中与功能障碍相关的副作用至关重要.
- 解决CE设备故障对于提高患者安全和诊断准确度至关重要.
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