描述与头骨具相关的并发症:对制造商和用户设施设备经验数据库的审查
Harshal A Shah1, Neel H Mehta2, Shyle H Mehta1
1Department of Neurological Surgery, Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA.
Clinical neurology and neurosurgery
|November 9, 2023
概括
在神经外科手术中使用的头骨可以发生故障,机械故障和滑动是常见的. 虽然大多数患者的伤害都是伤,但严重的并发症和死亡是罕见的,但有可能发生.
科学领域:
- 神经外科 神经外科
- 医疗器械安全 医疗器械安全
- 患者的治疗结果.
背景情况:
- 在神经外科手术过程中,头部固定是必要的.
- 之前关于与头骨结相关的不良事件的报道是有限的.
- 要了解这些事件的全部范围,需要进行全面的分析.
研究的目的:
- 使用制造商和用户设施设备体验 (MAUDE) 数据库,分析与神经外科头骨具相关的不良事件.
- 为了确定最常见的设备故障和患者受伤的类型.
- 描述严重不良事件和死亡的频率和性质.
主要方法:
- 在MAUDE数据库中查询了2013年1月至2022年12月的头骨事件.
- 设备故障被分类为机械故障,滑动,污染或其他.
- 患者的伤害被分类为磨损,伤,血瘤,骨折,内出血或其他.
主要成果:
- 在3672份报告中,73.2%是设备故障,主要是机械故障 (50.7%) 和滑动 (47.7%).
- 在26.8%的病例中报告了患者受伤,伤是最常见的 (78.9%).
- 报告的严重事件包括骨折,内出血和5例死亡,尽管很少发生.
结论:
- 马德数据库为与神经外科头骨结相关的报道不足的不良事件提供了宝贵的见解.
- 机械故障和设备滑动是故障的主要原因.
- 伤是最常见的患者伤害,而严重的并发症仍然很少见.
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