与气管切除术相关的不良事件:一个MAUDE数据库分析分析
Vishal Narwani1, Sydney Dacey2, Michael Z Lerner1
1Division of Otolaryngology, Department of Surgery, Yale School of Medicine, New Haven, Connecticut, USA.
概括
设备故障,特别是袖口问题,是气管切除术中最常见的并发症. 制造商和用户设施设备体验 (MAUDE) 数据库有助于识别这些不良事件.
科学领域:
- 医疗器械 医疗器械
- 患者安全 患者安全
- 手术并发症 手术并发症
背景情况:
- 气管切除术是一种常见的外科手术手术.
- 气管切除术的并发症得到了充分的记录,但对器械特定问题的研究较少.
- 现有的文献往往依赖于孤立的病例报告.
研究的目的:
- 用FDA的MAUDE数据库分析与气管切除器件相关的并发症.
- 为了识别与气管切除器件故障相关的常见和罕见不良事件.
- 为了补充有关气管切除术并发症的现有文献.
主要方法:
- 追溯的横截面研究设计.
- 利用美国食品和药物管理局 (FDA) 制造商和用户设施设备体验 (MAUDE) 数据库从2015年至2020年.
- 查询了MAUDE数据库,查找与气管切除手术相关的不良事件.
主要成果:
- 在开放式气管切除术中发现了3086次不良事件,而在穿皮气管切除术中发现了52次不良事件.
- 设备故障是主要原因 (93%为开放,73%为皮肤穿).
- 袖口故障是最常见的与设备相关的事件 (59%为开放式,29%为皮肤穿透式).
结论:
- 马德数据库对于识别气管切除器件相关故障非常有价值.
- 调查结果强调了设备故障的普遍性,特别是袖子问题.
- 这项研究补充了现有的文献,通过提供更广泛的设备并发症概述.
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