Abstract：
BACKGROUND: 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.
METHODS: A single-centre descriptive study was conducted in which risk management was carried out by establishing a risk map using FMEA methodology.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: A single-centre descriptive study was conducted in which risk management was carried out by establishing a risk map using FMEA methodology.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：患者安全在提供优质医疗保健方面至关重要，并构成了医疗保健系统的全球关注。对分化良好的甲状腺癌患者进行放射性碘治疗并非没有风险。本研究的目的是确定，评估和减轻与此程序相关的风险。
方法：进行了单中心描述性研究，通过使用FMEA方法建立风险图来进行风险管理。
结果：基于过程图，分析了处理过程三个阶段的6个子过程和23种故障模式。根据风险优先数(RPN)，风险最高的子流程是行政管理(RPN82)，其次是治疗本身和治疗后成像（均为RPN70）。整个过程RPN为300(156预处理，74处理和70后处理)获得。与患者直接相关的失败构成高风险。实施核查制度,尽早执行任务和提供高质量的医疗信息是最相关的预防措施。
结论：FMEA方法在放射性碘治疗风险管理中的应用是提高该过程质量和安全性的宝贵工具。风险图已经能够识别不同阶段的故障，评估其原因和影响，对已识别的风险进行优先排序，并实施可监控的预防和纠正措施，确保所采取的行动的有效性。
方法：进行了单中心描述性研究，通过使用FMEA方法建立风险图来进行风险管理。
结果：基于过程图，分析了处理过程三个阶段的6个子过程和23种故障模式。根据风险优先数(RPN)，风险最高的子流程是行政管理(RPN82)，其次是治疗本身和治疗后成像（均为RPN70）。整个过程RPN为300(156预处理，74处理和70后处理)获得。与患者直接相关的失败构成高风险。实施核查制度,尽早执行任务和提供高质量的医疗信息是最相关的预防措施。
结论：FMEA方法在放射性碘治疗风险管理中的应用是提高该过程质量和安全性的宝贵工具。风险图已经能够识别不同阶段的故障，评估其原因和影响，对已识别的风险进行优先排序，并实施可监控的预防和纠正措施，确保所采取的行动的有效性。
