与一次性支气管镜相关的不良事件:来自MAUDE数据库的分析
Xibin Su1, Huitong Cheng1, Wentao Rao1
1Department of Clinical Medicine, Medcaptain Medical Technology Co., Ltd., Shenzhen, Guangdong, People's Republic of China.
Medical engineering & physics
|December 6, 2025
概括
单次使用的灵活支气管镜 (SUFB) 在减少手术期间的病毒传播方面表现有前途. 然而,设备断裂和图像丢失是常见的问题,需要持续的安全监控.
科学领域:
- 医疗器械 医疗器械
- 肺部病理学 肺部病理学
- 传染病控制和控制传染病
背景情况:
- 支气管镜检查是一种产生气溶的手术,具有很高的病毒传播风险,特别是在COVID-19大流行期间.
- 单次使用的灵活支气管镜 (SUFB) 可减轻卫生保健工作者接触SARS-CoV-2的风险,并降低患者感染风险.
研究的目的:
- 分析与SUFBs相关的不良事件和并发症.
- 描述 SUFB 使用的风险减轻策略.
- 通过检查MAUDE数据库来确保患者的安全.
主要方法:
- 在FDAMAUDE数据库中对SUFBs进行评估的不良事件 (2014年1月至2025年6月).
- 根据设备问题和患者的结果,手动审查和分类280份报告.
主要成果:
- 280个与设备相关的问题和286个患者的结果报告了SUFBs.
- 主要的设备问题:断裂/骨折 (30.4%) 和图像/显示损失 (20.4%).
- 患者最常见的不良事件:异物和气道阻塞.
结论:
- 这项研究提高了对SUFB相关问题的理解.
- 强调需要对SUFB的安全性和有效性进行持续监测.
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