Nakano Shiho, Kotani Toshiaki, Nakajima Arata, Sonobe Masato, Inakuma Kayo, Ohtori Seiji, Nakagawa Koichi
Department of Orthopaedic Surgery, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura, Chiba 285-0841, Japan; Department of Rehabilitation, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura, Chiba 285-0841, Japan.
Department of Orthopaedic Surgery, Seirei Sakura Municipal Hospital, 2-36-2 Ebaradai, Sakura, Chiba 285-8765, Japan.
J Orthop Sci. 2025 Jul;30(4):711-717. doi: 10.1016/j.jos.2024.09.008. Epub 2024 Oct 15.
Patient safety is crucial in high-risk specialties such as orthopedic surgery due to the significant incidence of preventable adverse events. Analyzing extensive databases of orthopedic surgery-related incidents in operating rooms is vital for enhancing medical safety and identifying targeted interventions. This study analyzed orthopedic surgery-related incidents in operating rooms using a nationwide incident reporting database in Japan to identify risk factors associated with severe harm.
We extracted orthopedic surgery-related incidents in the operating room from the Japan Council for Quality Health Care's database, which contained 127,207 near-miss and adverse event reports recorded between January 1, 2010 and September 30, 2022. We analyzed 882 incident cases, focusing on patient demographics, incident timing, surgical site, incident causes, and severity levels.
The most incidents involved surgeons (93.3 %) with an average of 16.0 ± 8.5 years of experience. The frequent causes were "failure to check" (48.0 %) and "misjudgment" (24.0 %), which were non-technical errors. "Errors in methods/procedures" accounted for 37.1 % of incidents, possibly due to a wide variety of surgical approaches and implants used in orthopedic surgeries. Regarding severity, 86 % were critical incidents that threatened patients' livelihoods or lives. Surgeries involving surgeons had a significantly higher risk of severe harm than those involving healthcare professionals other than surgeons (odds ratio: 3.311, 95 % confidence interval: 1.858-5.901).
This study revealed that most of orthopedic surgery-related incidents in operating rooms involved experienced surgeons and resulted in severe patient harm. The frequent causes were failure to check, misjudgment, and errors in methods/procedures. These highlight the crucial role of orthopedic surgeons in actively contributing to medical safety databases and fostering a culture of reporting within their field.
由于可预防不良事件的发生率较高，患者安全在骨科手术等高风险专科中至关重要。分析手术室中大量与骨科手术相关的事件数据库对于提高医疗安全性和确定有针对性的干预措施至关重要。本研究使用日本的全国性事件报告数据库分析了手术室中与骨科手术相关的事件，以确定与严重伤害相关的风险因素。
我们从日本医疗质量理事会的数据库中提取了手术室中与骨科手术相关的事件，该数据库包含2010年1月1日至2022年9月30日期间记录的127,207份未遂事件和不良事件报告。我们分析了882例事件案例，重点关注患者人口统计学、事件发生时间、手术部位、事件原因和严重程度级别。
大多数事件涉及外科医生（93.3%），平均经验为16.0±8.5年。常见原因是“未检查”（48.0%）和“判断错误”（24.0%），这些是非技术性错误。“方法/程序错误”占事件的37.1%，这可能是由于骨科手术中使用的手术方法和植入物种类繁多。关于严重程度，86%是威胁患者生计或生命的严重事件。涉及外科医生的手术比涉及外科医生以外的医疗专业人员的手术造成严重伤害的风险显著更高（优势比：3.311，95%置信区间：1.858 - 5.901）。
本研究表明，手术室中大多数与骨科手术相关的事件涉及经验丰富的外科医生，并导致患者严重伤害。常见原因是未检查、判断错误和方法/程序错误。这些突出了骨科外科医生在积极为医疗安全数据库做出贡献以及在其领域内营造报告文化方面的关键作用。
