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Endovascular Stapler Complications During Minimally Invasive Nephrectomy: An Updated Review of the FDA MAUDE Database From 2009-2019.血管内吻合器在微创肾切除术中的并发症:2009 年至 2019 年 FDA MAUDE 数据库的最新回顾。
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The nature, magnitude, and reporting compliance of device-related events for intravenous patient-controlled analgesia in the FDA Manufacturer and User Facility Device Experience (MAUDE) database.美国食品药品监督管理局(FDA)制造商和用户设施设备经验(MAUDE)数据库中与静脉自控镇痛设备相关事件的性质、严重程度及报告合规情况。
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2014 - 2024年美国手术室火灾的发生率及根本原因

Prevalence and root causes of operating room fires in the United States 2014-2024.

作者信息

Attia Monica M

机构信息

University of California, Davis, Sacramento, CA, USA.

出版信息

Patient Saf Surg. 2025 Jun 2;19(1):18. doi: 10.1186/s13037-025-00441-3.

DOI:10.1186/s13037-025-00441-3
PMID:40457428
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12131830/
Abstract

BACKGROUND

Operating room fires, though rare, pose serious risks to patient and operator safety. Among the known ignition sources, light-emitting surgical devices-including fiberoptic cables, headlamps, and light boxes-are increasingly recognized contributors. However, the true prevalence and underlying causes remain under-characterized in national surveillance data. This study hypothesized that operator error is a leading cause of light-source-related fires and sought to identify specific device types, procedural timing, and preventable risk factors involved in these adverse events.

METHODS

Reports from the U.S. FDA's MAUDE database were analyzed for light source-related operating room fires from January 1, 2014, to January 1, 2024. Events were categorized by device type, procedural timing, root cause, and resultant injury.

RESULTS

A total of 45 adverse events were analyzed. Most fires were associated with light sources (33.3%), light headlamps (31.1%), and fiberoptic cables (20%). Intraoperative fires comprised the majority (35.6%). Operator error accounted for 37.8% of cases, with common errors including device mishandling (35.2%) and failure to detect damage (17.6%). Only 13.3% required intra-procedural interventions; injuries included one patient burn and two operator injuries.

CONCLUSIONS

Most operating room fires involving light sources were linked to modifiable operator errors. These findings underscore the urgent need for preventive strategies-including mandatory training, regular equipment checks, and improved design standards-to reduce intraoperative fire risk and enhance surgical safety.

摘要

背景

手术室火灾虽罕见,但对患者和手术人员的安全构成严重风险。在已知的火源中,发光手术设备,包括光纤电缆、头灯和灯箱,越来越被认为是火灾的促成因素。然而,在国家监测数据中,其真实发生率和潜在原因仍未得到充分描述。本研究假设手术人员失误是与光源相关火灾的主要原因,并试图确定这些不良事件中涉及的特定设备类型、手术时机以及可预防的风险因素。

方法

分析了美国食品药品监督管理局(FDA)不良事件报告系统(MAUDE)数据库中2014年1月1日至2024年1月1日期间与光源相关的手术室火灾报告。根据设备类型、手术时机、根本原因和造成的伤害对事件进行分类。

结果

共分析了45起不良事件。大多数火灾与光源(33.3%)、头灯(31.1%)和光纤电缆(20%)有关。术中火灾占大多数(35.6%)。手术人员失误占病例的37.8%,常见失误包括设备操作不当(35.2%)和未检测到损坏(17.6%)。只有13.3%的事件需要术中干预;受伤情况包括1例患者烧伤和2例手术人员受伤。

结论

大多数涉及光源的手术室火灾与可改变的手术人员失误有关。这些发现强调迫切需要采取预防策略,包括强制培训、定期设备检查和改进设计标准,以降低术中火灾风险并提高手术安全性。