S112
Brachytherapy - Physics
ESTRO 2026
Digital Poster 138
FMEA-Based Risk Assessment of Catheter Reconstruction in Brachytherapy Planning: Implications for Dosimetric Accuracy, Patient Safety and Quality Sheng-Fang Huang 1,2 , Jo-Ting Tsai 1,3 , Chee-Kin Then 1,4 , Chih-Chieh Chang 1 , Chun-Yuan Kuo 1,2 , Li-Jhen Chen 1 , Jang-Chun Lin 1,3 , Wei-Kai Chuang 1,5 , Ming-Hsien Li 1,3 1 Department of Radiation Oncology, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan. 2 School of Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan. 3 Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. 4 Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. 5 Department of Radiation Oncology, Saint Paul’s Hospital, Taoyuan, Taiwan Purpose/Objective: To systematically identify and prioritize failure modes in the catheter reconstruction step of gynecologic brachytherapy planning, and to recommend targeted corrective actions to improve dosimetric accuracy, patient safety, and overall treatment quality. Material/Methods: A quality-management team applied DGMP report No. 28 guidance to perform a failure mode and effects analysis (FMEA). Table 1 shows the risk rating systems for severity (S), occurrence (O), detectability (D) and net occurrence (NO). S, O and D were scored on 1–10 scales to compute risk priority numbers (RPN = S × O × D). Table 2 shows the risk matrix for determining the risk level from severity (S) and net occurrence (NO), scored on I–V scales . A complementary risk-matrix and an action-priority assessment were used to assign risk classes and action levels. Evaluation criteria and outcome tables follow the DGMP-Bericht Nr. 28 framework.
Results: Five critical failure modes (FMs) were identified within the catheter reconstruction sub-process. Table 3 shows the results of risk management for the catheter reconstruction in gynecological brachytherapy planning workflow. The highest-risk FM was “wrong catheter index” (mean RPN 74.3; S = 9), followed by inappropriate set source dwell positions and incorrect catheter encoding. Risk-matrix analysis placed these FMs in medium risk bands (R14–R15), while action- priority scoring classified three FMs as requiring high action level. Root causes were predominantly human factors and lack of standardized procedures. Recommended mitigations prioritized standardizing reconstruction protocols, reinforcing stepwise verification (including independent double checks), and implementing targeted staff training.
Conclusion: This structured FMEA reveals specific, actionable vulnerabilities in catheter reconstruction that may produce clinically significant dosimetric deviations. Implementing standardized protocols, strengthened verification and continuous education is expected to reduce high-priority errors, enhance dosimetric accuracy, and improve patient safety and treatment quality in gynecologic brachytherapy.
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