S1534
Interdisciplinary - Quality assurance and risk management
ESTRO 2026
5 Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy
Purpose/Objective Brachytherapy (Interventional Radiotherapy) is a radiotherapy technique involving the placement of radioactive sources in close proximity to the tumour site. Due to its high procedural complexity, rigorous clinical risk management is essential to prevent potential errors, ensure patient safety, and maintain therapeutic effectiveness. This study aimed to apply the FMEA (Failure Mode and Effects Analysis) methodology to the brachytherapy process to identify and assess potential critical points and to suggest improvement actions. Material/Methods The analysis was conducted at the Brachytherapy Unit of Radiotherapy Division, IRCCS European Institute of Oncology (IEO), Milan, Italy. FMEA was employed and used as a risk assessment tool. A dedicated team (one brachytherapy specialist and three RTTs, supported by the operational brachytherapy team) mapped the entire process, developed the risk analysis tool, and identified 118 Failure Modes (FMs). Each FM was evaluated for severity and occurrence, calculating of the Risk Priority Number (RPN) and ranking them into four intervention categories. Results The results reflect the expertise and perception of a skilled team, showing that most FMs were ranked as low or acceptable risk, while only four were categorized as medium risk (6 < RPN ≤ 12): incorrect patient preparation (7.0); applicator displacement (6.8); inappropriate indication for brachytherapy (6.1); error in the radiation oncologist’s report and/or clinical record (e.g., wrong side, incorrect pathology, etc.) (6.1). No FM was identified as high risk (RPN > 12). Some FMs with S ≥ 4, despite low occurrence probability,
Conclusion FMEA is an effective methodology for clinical risk assessment and prevention, encouraging a safer environment, increasing professional awareness and guiding continuous improvement of best practices in brachytherapy. References • Pobbiati C, et al. Clinical risk analysis of the patient’s path in an ARC through FMEA. method. Journal of Biomedical Practitioners. 2019 • ISS, AIFM, AIRO. QA in brachytherapy: proposals for guidelines concerning clinical, technological and physical-dosimetric aspects. 2003 www.osti.gov/etdeweb/servlets/purl/20107864& nbsp • Wadi-Ramahi S, et al. FMEA in image-guided HDR- BT: Quality control optimization to reduce errors in treatment volume. Brachytherapy. 2016 • Huq MS, et al. The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management. Medical Physics. 2016 • Swamidas J, et al. Implementation of FMEA for HDR- BT at Tata Memorial Hospital, Mumbai, India. Cancer/Radiotherapie. 2018 Keywords Brachytherapy, FMEA, Clinical Risk Management Development of Patient Safety Indicators on a national level: Results from a multicenter-multi- methods study Andrea Baehr 1 , Eva Christalle 2 , Maximilian Grohmann 1 , Felicitas Schwenzer 2 , Nina Michalowski 3 , Maria Jäckel 1 , Isabelle Scholl 2 1 Department of Radiation Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 2 Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Poster Discussion 3905
were additionally associated with potentially significant clinical consequences. Some areas requiring attention were primarily related to
communication and human factors, emphasizing the need to strengthen interprofessional communication, standardize procedures, and systematically implement operational checklists for complex tasks.
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