Servicio de Medicina Nuclear, Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain.
Facultad de la Salud, Universidad Internacional de la Rioja, La Rioja, Spain; Servicio de Microbiología, Hospital Universitario Virgen de la Victoria, Málaga, Andalucía, Spain.
Rev Esp Med Nucl Imagen Mol (Engl Ed). 2024 Jul-Aug;43(4):500029. doi: 10.1016/j.remnie.2024.500029. Epub 2024 Jul 11.
Patient safety is paramount in providing quality healthcare and constitutes a global concern for healthcare systems. Radioiodine treatment to patients with well-differentiated thyroid cancer is not without risks. The aim of this study is to identify, evaluate and mitigate the risks associated with this procedure.
A single-centre descriptive study was conducted in which risk management was carried out by establishing a risk map using FMEA methodology.
Based on the process map 6 sub-processes and 23 failure modes in the three phases of the treatment process were analysed. According to risk priority number (RPN), the sub-process with the highest risk was administrative management (RPN 82), followed by treatment per se and post-treatment imaging (both with RPN 70). An overall process RPN of 300 (156 pre-treatment, 74 treatment and 70 post-treatment) was obtained. Failures directly related to the patient pose a high risk. The implementation of verification systems, performing tasks earlier and providing quality medical information are the most relevant preventive measures to be implemented.
The application of the FMEA methodology in the risk management for radioiodine treatment is a valuable tool for improving the quality and safety of this process. The risk map has been able to identify failures at different stages, assess their causes and effects, prioritise the risks identified and implement preventive and corrective measures that can be monitored, ensuring the effectiveness of the actions taken.
保障患者安全是提供优质医疗保健的重中之重，也是全球医疗体系关注的焦点。对分化型甲状腺癌患者进行放射性碘治疗并非没有风险。本研究旨在识别、评估和减轻该程序相关的风险。
本研究为单中心描述性研究，通过使用失效模式与效应分析（FMEA）方法建立风险图来进行风险管理。
根据流程图，分析了治疗过程三个阶段中的 6 个子过程和 23 种失效模式。根据风险优先数（RPN），风险最高的子过程是行政管理（RPN 82），其次是治疗本身和治疗后影像学检查（RPN 均为 70）。总过程 RPN 为 300（156 个预处理、74 个治疗和 70 个治疗后）。与患者直接相关的故障存在高风险。实施验证系统、提前执行任务和提供高质量的医疗信息是最需要实施的预防措施。
在放射性碘治疗的风险管理中应用 FMEA 方法是提高该过程质量和安全性的有价值的工具。风险图能够识别不同阶段的故障，评估其原因和影响，对识别出的风险进行优先级排序，并实施可监控的预防和纠正措施，确保所采取措施的有效性。
