Advancing risk management in nuclear medicine diagnostic and therapy through incident-driven risk management tools

Accidental or unintended exposures in nuclear medicine present significant risks, demanding proactive and systematic risk management strategies. This study explores the development and implementation of a novel software tool that integrates Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) into a unified platform tailored for nuclear medicine. The tool addresses the complexities of risk assessment across diagnostic and therapeutic workflows, offering customizable templates and a streamlined process for identifying, prioritizing, and mitigating failure modes. A multicenter study involving nuclear medicine departments of various sizes demonstrated the tool's efficacy in standardizing risk analysis and enhancing interdisciplinary collaboration. Key scenarios, such as errors in radiopharmaceutical preparation and administration, were assessed, with rankings assigned based on a refined Risk Priority Number (RPN) system. The results underscore the transformative potential of combining FMEA and FTA in nuclear medicine, addressing the limitations of standalone methodologies. This approach improves workflow efficiency and ensures a robust framework for patient safety. Future directions include expanding the tool's applications, refining templates, and fostering a proactive culture of risk assessment. These advancements pave the way for safer, more efficient practices in nuclear medicine, benefiting patients and professionals alike.