与一次性支气管镜相关的不良事件：来自MAUDE数据库的分析

IF 2.3 4区医学 Q3 ENGINEERING, BIOMEDICAL

Medical Engineering & Physics Pub Date : 2025-09-23 DOI:10.1016/j.medengphy.2025.104443

Xibin Su, Huitong Cheng, Wentao Rao, Chenghong Xue, Donghui Gan, Binjian Liu

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引用次数: 0

摘要

背景：支气管镜检查是一种产生气溶胶的过程，与病毒传播的高风险相关，特别是在冠状病毒病（COVID-19）大流行期间。这种情况加速了一次性柔性支气管镜（SUFBs）的采用，因为它们有可能减少医护人员接触SARS-CoV-2并降低患者感染风险。本研究旨在分析报道的与sufb相关的不良事件和并发症，同时通过检查制造商和用户设施设备体验（MAUDE）数据库的数据，描绘风险缓解策略的建议，并确保患者安全。方法我们对2014年1月1日至2025年6月30日FDA MAUDE数据库中记录的与sufb相关的不良事件进行了评估。所有的报告都是根据主要的器械问题和任何相关的患者结果进行人工审查和分类的。结果共发表了280份关于sufb的报告。人工审查将这些分类为280个与器械相关的主要问题和286个与患者相关的结果。器械相关问题的主要类别主要与断裂/骨折（85例，30.4%）和图像/显示丢失（57例，20.4%）有关。在患者不良事件中，最常见的是异物和气道阻塞。结论我们的研究增加了现有的临床文献和知识体系，提供了对与sufb相关的潜在问题的全面了解。它强调了持续监测和警惕的必要性，以确保sufb的安全性和有效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Adverse events associated with single-use bronchoscopes: analysis from the MAUDE database

Background

Bronchoscopy is an aerosol-generating procedure and associated with a high risk of viral transmission, particularly during the coronavirus disease (COVID-19) pandemic. This circumstance has expedited the adoption of single-use flexible bronchoscopes (SUFBs) due to their potential to mitigate healthcare personnel exposure to SARS-CoV-2 and reduce patient infection risks.

Objective

This study aims at analyzing reported adverse events and complications associated with SUFBs, while delineating recommendations for risk mitigation strategies and ensuring patient safety through an examination of data from the Manufacturer and User Facility Device Experience (MAUDE) database.

Methods

We conducted an evaluation of adverse events related to SUFBs as documented in the FDA MAUDE database from January 1, 2014, to June 30, 2025. All reports were manually reviewed and categorized based on the primary device problem and any associated patient outcomes.

Results

A total of 280 reports were issued regarding SUFBs. Manual review categorized these into 280 primary device-related problems and 286 patient-related outcomes. The primary category of device-related problems predominately pertained to breakage/fracture (85 cases; 30.4 %), and a loss of image/display (57 cases; 20.4 %). Among patient adverse events, the most frequently encountered were foreign bodies and airway obstruction.

Conclusion

Our study augments the existing clinical literature and body of knowledge by providing a comprehensive understanding of potential problems related to SUFBs. It underscores the imperative for continuous surveillance and vigilance to ensure the safety and effectiveness of SUFBs.

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来源期刊

Medical Engineering & Physics 工程技术-工程：生物医学

CiteScore

4.30

自引率

4.50%

发文量

172

审稿时长

3.0 months

期刊介绍： Medical Engineering & Physics provides a forum for the publication of the latest developments in biomedical engineering, and reflects the essential multidisciplinary nature of the subject. The journal publishes in-depth critical reviews, scientific papers and technical notes. Our focus encompasses the application of the basic principles of physics and engineering to the development of medical devices and technology, with the ultimate aim of producing improvements in the quality of health care.Topics covered include biomechanics, biomaterials, mechanobiology, rehabilitation engineering, biomedical signal processing and medical device development. Medical Engineering & Physics aims to keep both engineers and clinicians abreast of the latest applications of technology to health care.