Grassi Simone, Focardi Martina, Santori Francesco, Guerini Marta, Ferri Elisa, Ferretti Giulia, Bianchi Ilenia, Autieri Filomena, Pinchi Vilma
Laboratory on the Management of Healthcare Incidents (LOGOS), Department of Health Sciences, University of Florence, Florence, Italy.
Section of Forensic Medical Sciences, Department of Health Sciences, University of Florence, Florence, Italy.
Front Med (Lausanne). 2025 Apr 1;12:1526271. doi: 10.3389/fmed.2025.1526271. eCollection 2025.
Retained surgical foreign bodies are supplies and devices unintentionally left at the surgical site. They are generally considered never events, albeit even full compliance with procedures can only minimize the risk of their occurrence. As never events, affected patients often allege gross negligence, and hospitals are often forced to compensate for the damages. Despite the fact that the physical consequences of the retention are usually mild and temporary, and thus the compensation paid may be hypothesized to be correspondently low, clear data on the medico-legal outcomes of these claims-both extrajudicial and judicial-and the average compensation have not yet been described.
This paper presents a retrospective study on the related claims received between 1 January 2010 and 30 May 2024 by a large university hospital in Florence (Italy). The study aimed to deduce their incidence and mean costs, as well as the risk of medical malpractice claims leading to criminal complaints.
We identified 27 eligible cases, with a mean compensation of €20,695.49. During the same period, the claims unrelated to retained foreign bodies, used as controls, had a mean compensation of €67,542.26. When considering only non-fatal events, criminal lawsuits were present in 12% of the cases compared to 6% in the control group, which fell within the same compensation range. The majority of the cases (63%) were directly managed by the hospital, although this was a lower percentage compared to the control cases (76%).
In conclusion, even if the economic dimension of claims related to retained surgical foreign bodies is relatively contained, they are associated with a 2-fold risk of criminal lawsuits for doctors. In addition, patients are less confident about out-of-court settlements provided directly by hospital committees compared to judicial court trials. This indicates that patients perceive a retained surgical foreign body (RSFB) as a never event, which requires less justification compared to other wrongful medical care incidents. This perception is likely driven more by a breach of trust in doctors and hospitals than by the severity of consequences, which are typically mild or limited to temporary impairment.
手术中遗留的异物是无意中遗留在手术部位的耗材和器械。它们通常被视为严重医疗差错，尽管即使完全遵守程序也只能将其发生风险降至最低。作为严重医疗差错，受影响的患者往往指控存在重大过失，医院也常常被迫赔偿损失。尽管异物遗留造成的身体后果通常较轻且为暂时性，因此可以推测所支付的赔偿相应较低，但关于这些索赔（包括庭外和解和司法索赔）的法医学结果以及平均赔偿金额的明确数据尚未见报道。
本文对意大利佛罗伦萨一家大型大学医院在2010年1月1日至2024年5月30日期间收到的相关索赔进行了回顾性研究。该研究旨在推断其发生率和平均成本，以及导致刑事指控的医疗事故索赔风险。
我们确定了27例符合条件的病例，平均赔偿金额为20,695.49欧元。在同一时期，作为对照的与异物遗留无关的索赔，平均赔偿金额为67,542.26欧元。仅考虑非致命事件时，12%的病例存在刑事诉讼，而对照组为6%，两组赔偿范围相同。大多数病例（63%）由医院直接处理，尽管这一比例低于对照病例（76%）。
总之，即使与手术中遗留异物相关的索赔经济层面相对有限，但它们与医生面临刑事诉讼的风险增加两倍相关。此外，与司法审判相比，患者对医院委员会直接提供的庭外和解的信心较低。这表明患者将手术中遗留异物（RSFB）视为严重医疗差错，与其他不当医疗事件相比，其需要的理由更少。这种认知可能更多地是由对医生和医院的信任破裂驱动，而非后果的严重程度，后者通常较轻或仅限于暂时的损害。
