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马德数据库和欧斯塔基管气球扩张:不良事件的评估和销售数据

Zaid Shareef¹, Robert M Conway², Trevor Creaman³

¹Department of Otolaryngology - Head and Neck Surgery, Ascension Macomb-Oakland Hospital, 27351 Dequindre Rd, Madison Heights, MI, USA.

American journal of otolaryngology

|August 6, 2024

概括

欧斯塔基管气球扩张 (ETBD) 是一种安全的手术,并发症率低. 皮下肺是最常见的不良事件,对于ETBD干预措施来说,设备故障率非常低.

科学领域:

耳鼻喉科耳鼻喉科耳鼻喉科
医疗器械安全医疗器械安全
神经外科神经外科

背景情况:

尤斯塔基管功能障碍 (ETD) 显著影响生活质量.
欧斯塔基管气球扩张 (ETBD) 是一种越来越多地用于ETD的治疗方法.
了解与ETBD相关的安全概况和不良事件至关重要.

研究的目的:

为了评估与ETBD相关的不良事件 (AE) 和设备故障 (DM),使用MAUDE数据库.
为了在不同的ETBD设备中比较AE和DM率.
使用销售数据计算AE和医疗器械报告 (MDR) 费率.

主要方法:

对与ETBD相关的MDR的MAUDE数据库的分析.
根据设备类型 (Aera,Xpress,Audion) 分类MDR.
使用销售数据计算每个设备的AE和MDR率.

主要成果:

在ETBD中发现了18种MDR,其中Aera (50%) 和Xpress (44.4%) 报告最多.
皮下肺是最常见的AE (n=4).
阿埃拉气球显示低MDR率 (0.0128%) 和AE率 (0.0058%),而奥迪的MDR和AE率为0.0164%.

结论:

ETBD是一种安全的手术,并发症最小,主要是皮下肺气.
艾拉气球表现出值得称赞的低MDR率,支持其安全性.
调查结果有助于为患者提供有关术后期望和知情同意的咨询.

关键词:

不良事件是不良事件.气球扩张气球扩张尤斯塔希安管是什么意思尤斯塔基管的功能障碍

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