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与使用植入物进行切割性玻璃眼外科手术的设备相关的不良事件,据报告给FDA的MAUDE数据库
Kaylie Chen1, Pooja Pendri1, Kyle Kovacs1
1Israel Englander Department of Ophthalmology, Weill Cornell Medical College, 1305 York Avenue, 11th Floor, New York, NY, USA.
概括
这项研究分析了食品和药物管理局 (FDA) 对切割性玻璃眼外科手术设备的数据. 它确定了常见的并发症,如低血压和设备虹膜触摸,以改善患者咨询和手术准备.
科学领域:
- 眼科医生 眼科 眼科
- 医疗器械安全 医疗器械安全
- 玻璃眼的手术 玻璃眼的手术
背景情况:
- 用植入物进行切割性玻璃眼外科手术对于晚期或耐火玻璃眼非常重要.
- 食品和药物管理局 (FDA) 制造商和用户设施设备体验 (MAUDE) 数据库提供现实世界的并发症数据.
- 通过分析MAUDE数据,可以确定不同玻璃眼外科手术设备的风险概况.
研究的目的:
- 通过使用FDA MAUDE数据,识别和分类与特定的切口玻璃眼手术设备相关的并发症.
- 制定常用的玻璃眼排水和过装置的风险概况.
- 提供对现实世界的设备性能和不良事件的见解.
主要方法:
- 从2012年1月到2021年12月搜索了FDA的MAUDE数据库.
- 包括特定的品牌:艾哈迈德ClearPath,艾哈迈德玻璃眼,贝尔维尔特,Ex-PRESS和Molteno.
- 根据复杂性分类报告,不包括重复和非特定的比较文献.
主要成果:
- 1379份报告详细介绍了2429个不良事件,符合纳入标准.
- 最常见的并发症包括低垂体/低垂体黄斑病变 (284),设备与虹膜接触 (282),以及设备封闭 (213).
- 其他显著事件:眼内压升高 (IOP) (210),装置扩张 (176),输送系统故障 (166) 和角膜问题 (128).
结论:
- 该研究强调了基于真实世界的数据的切割性玻璃眼外科手术设备的临床上最相关的不良事件.
- 这些发现可以帮助外科医生在患者咨询和设备植入的手术前规划方面提供帮助.
- 了解特定于设备的并发症可以提高外科手术决策和患者安全.
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