S2844
RTT - RTT education, training, and advanced practice
ESTRO 2026
Medical University, Taipei, Taiwan. 5 Department of Radiation Oncology, Saint Paul’s Hospital, Taoyuan, Taiwan Purpose/Objective: To improve patient safety and workflow reliability in gynecological brachytherapy planning by prioritizing failure modes (FMs) using three FMEA-based criticality methods under DGMP No. 28 guidelines: risk priority number (RPN), risk matrix (RM), and action priority (AP). The objective is to assess the consistency and clinical relevance of these methods in guiding risk stratification and corrective actions. Material/Methods: Figure 1 illustrates the brachytherapy planning workflow, segmented into discrete subprocesses. In total, 41 FMs were catalogued for further analysis. Each FM was scored for severity (S), occurrence (O), detectability (D) and net occurrence (NO) according to the ranking system detailed in Table 1. We applied three criticality FMEA methods under DGMP No. 28 guidelines:• Risk Priority Number (RPN): Calculated as the product S × O × D for each FM and rank three risk classes (acceptable, tolerable, unacceptable)• Risk Matrix (RM): Mapped S against NO to assign FMs into three risk levels (low, medium, high).• Action Priority (AP): Assigned each FM to one of three action levels based on S, D, and O, following the DGMP- recommended AP decision table.The results were compared to assess concordance in risk stratification and to identify discrepancies that may influence clinical decision-making.
Results: Table 2 shows the risk categories for the gynecological brachytherapy planning workflow using three FMEA criticality methods. The three methods demonstrated partial overlap in identifying high-risk FMs. Key hazards such as incorrect CTV definition (RPN=108), contouring errors (RPN=90), and wrong catheter index (RPN=81) were consistently classified as high priority across all methods. The RM method provided a more intuitive visualization of risk categories but lacked the granularity of AP in guiding specific interventions. AP was particularly effective in highlighting workflow vulnerabilities stemming from inadequate training, lack of standardization, and communication gaps— factors that were underrepresented in RPN-based analysis. Comparison across methods reveals that the RM and AP approaches emphasize follow-up on medium and high risk failure modes, whereas the RPN method tends to group the majority of modes under tolerable classifications. This disparity highlights how choice of criticality metric under DGMP 28 guidelines can significantly influence risk categorization and subsequent decision-making.
Conclusion: Multimodal FMEA enhances the robustness and clinical relevance of risk assessment in brachytherapy planning. While RPN provides a useful baseline, AP offers finer prioritization aligned with clinical urgency. RM supports stakeholder communication but benefits from integration with AP. A combined approach is recommended to strengthen safety culture, optimize workflows, and reduce preventable errors. Keywords: FMEA, patient safety, workflow References: 1. DGMP-Bericht Nr. 25: Eine Prozessbeschreibung zur Umsetzung des Risikomanagements für die Strahlenbehandlung gemäß §126 StrlSchV, 2022. 2. DGMP-Bericht Nr. 28: Eine Durchführungshilfe zur
Umsetzung des Risikomanagements für die Strahlenbehandlung gemäß § 126 StrlSchV:
Prozessbasierter Ansatz, 2024.3. Huq MS, Fraass BA, Dunscombe PB, Gibbons Jr JP, Ibbott GS, Mundt AJ, et al. The report of Task Group 100 of the AAPM: application of risk analysis methods to radiation therapy quality management. Med Phys 2016;43(7):4209.
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