从2002年到2023年,对骨科器械进行高风险召回的表征和时间延迟
Cemil Cihad Gedik1, Curtis Walker, Houssam Bouloussa
1From the Department of Orthopedic Surgery, University of Missouri-Kansas City (Gedik, Bouloussa, Krumme, Cil, and Dubin), University of Missouri-Kansas City, School of Medicine (Walker), Department of Biomedical and Health Informatics, University of Missouri-Kansas City, Kansas City, MO (Cheng).
The Journal of the American Academy of Orthopaedic Surgeons
|December 26, 2025
概括
一类的骨科器械召回,通常是由于510(k) 清除的植入物中的设计缺陷,显示在不良事件报告和召回之间存在显著的延迟,特别是在关节整形器件中. 加强市场后监测对于患者安全至关重要.
科学领域:
- 整形外科手术 整形外科手术
- 医疗器械安全 医疗器械安全
- 监管科学 监管科学
背景情况:
- 骨科设备占医疗器械的很大一部分,很大一部分在FDA批准后十年内面临召回.
- 标志着可能造成严重伤害或死亡的I类召回是FDA最关心的问题,但对于骨科器件尚未进行系统分析.
- 有关对骨科植入物安全信号的及时响应存在担忧.
研究的目的:
- 系统地描述骨科器械的I类召回情况.
- 分析召回原因,授权途径和不良事件报告和正式召回之间的时间间隔.
- 确定骨科植入物的市场后监测需要改进的领域.
主要方法:
- 审查FDA召回数据库的I类骨科设备召回 (2002年11月至2023年12月).
- 根据子专业,授权途径 (510(k) 与PMA) 的产品分类,以及召回原因.
- 对FDA根本原因的重新分类和计算最早的不良事件报告 (AER) 和召回之间的间隔.
主要成果:
- 16个I类召回事件影响了20种骨科设备,主要是关节塑造 (50%) 和脊椎 (44%).
- 大多数被召回的设备 (87%) 通过510 (((k) 路径被清除,在69%的召回中引用了设计缺陷.
- 在最早的AER和召回之间观察到显著的延迟,关节整形术的中位数为5.8年,而脊椎器件的中位数为1.8年.
结论:
- 第I类整形外科的召回经常涉及510(k) 清除的设备的设计缺陷,在召回启动时有很大的延迟,特别是在关节整形植入物中.
- 食品和药物管理局分类和临床判断之间的差异,以及不一致的召回标签,需要改进市场后监督.
- 加强监测应涉及外科医生的协作和与现有注册表的整合,以便更早地检测有问题的骨科设备.
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