A Novel Hybrid PFMEA-HFMEA Framework for Risk Assessment in Medical Imaging: Insights from Developing Healthcare Systems

Introduction: Medical imaging modalities such as MRI and CT scans are indispensable for accurate diagnosis, yet they pose substantial operational and patient safety risks—particularly in resource-limited healthcare systems. Material and Methods: This applied methodological study, conducted from July 2024 to April 2025, used a four-phase methodology: scoping, data collection, framework development, and risk analysis. Data were gathered through FGDs involving radiologists, technicians and HSE experts and also with semi-structured interviews and process mapping, which identified 125 failure modes across nine workflow stages. PFMEA assessed operational risks, whereas HFMEA focused on patient-centric hazards. A composite risk indicator that comprising 40% PFMEA RPN and 60% HFMEA hazard score, prioritized risks. Statistical analyses, including Shapiro-Wilk, Spearman’s correlation and Kruskal-Wallis tests, were used to evaluate risk distributions and inter-stage variability. Results: The framework identified critical risks, such as insufficient operator training and staff fatigue, with post-process management and image reconstruction as high-risk phases. MRI and CT units showed distinct yet overlapping risk profiles that show significant inter-stage variability (p<0.001). The hybrid model integrated operational and clinical perspectives, which outperformed standalone FMEA methods. Conclusion: This hybrid PFMEA-HFMEA framework offers a scalable and context-sensitive approach to enhance patient safety with operational resilience in medical imaging. Further studies should authenticate the framework in different settings and investigate long-term mitigation strategies to enhance radiology risk management.