A FMEA-Based Risk Analysis of Nuclear Medicine Equipment Quality Control

In diagnostic nuclear medicine, quality control (QC) procedures are often conducted without structured risk-informed frameworks capable of systematically prioritizing failures with radiological, operational, or quantitative imaging impact. This study developed and applied an adapted Failure Modes and Effects Analysis (FMEA) model employing multidimensional severity criteria tailored to diagnostic nuclear medicine workflows to identify and prioritize failure modes affecting system stability, metrological consistency, and radiation safety. Risks were assessed employing failure occurrence (O), severity (S), and detection (D) scores, each ranked from 1 to 10. Risk Priority Numbers (RPN) were calculated as RPN = O × S × D, and critical failures were defined as RPN > 125 and S ≥ 7. The analysis identified 405 failure modes, resulting in 2,073 potential failures, with 23 categorized as critical risk, primarily associated with SPECT/SPECT-CT and PET/CT procedures. The highest-risk events included mishandling of radioactive sources during sensitivity testing and dose calibrator-PET/CT desynchronization, both affecting quantitative accuracy and radiation safety. Within the evaluated institutional context, the adapted FMEA framework enabled structured prioritization of QC-related vulnerabilities and identification of targets for risk-informed quality management interventions.