设备故障和与小肠囊内镜有关的患者相关的不良事件:对20年的MAUDE数据库分析分析
Eric S Tatro1, Sherif E Elhanafi1, Douglas G Adler2
1Division of Gastroenterology and Hepatology, Texas Tech University Health Sciences Center, El Paso, TX, USA (Eric S. Tatro, Sherif Elhanafi, Marc J. Zuckerman).
Annals of gastroenterology
|September 12, 2025
概括
分析了小肠囊内镜 (SBCE) 中的设备故障和患者不良事件. 陷入和留住异物是常见的,突出了改善患者选择和降低风险的领域.
科学领域:
- 胃肠病学 胃肠病学
- 医疗器械安全 医疗器械安全
- 内镜检查是指内镜检查.
背景情况:
- 小肠囊内镜 (SBCE) 对于诊断小肠出血,瘤和克罗恩病至关重要.
- 了解设备故障 (DF) 和患者相关不良事件 (PRAE) 对于安全使用SBCE至关重要.
研究的目的:
- 分析与小肠囊内镜 (SBCE) 系统相关的设备故障 (DF) 和患者相关的不良事件 (PRAE).
- 使用来自FDA的MAUDE数据库的数据来识别常见的DF和PRAE.
主要方法:
- 对SBCE系统的营销后监测数据从FDA的MAUDE数据库 (2000年1月至2023年12月) 中进行分析.
- 获得了352份报告,重点关注的是Pillcam SB®,Pillcam® Patency Capsule,Endocapsule®,CapsoCam®和MiroCam®系统.
主要成果:
- 在307份医疗器械报告中,共报告了398起DF和569起PRAE,主要针对Pillcam®系统.
- 最常见的DF包括设备被困 (53.2%),无法传输 (9.5%) 和无法记录 (8.7%).
- 最常见的PRAE是留存的异物 (24.6%),无意的辐射暴露 (18.2%) 和无意的麻醉暴露 (10.2%).
结论:
- 马德数据库的发现为SBCE设备故障和患者不良事件提供了关键的见解.
- 这些信息可以指导临床医生优化患者选择并最大限度地降低与SBCE程序相关的风险.
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