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Failure Modes and Effects Analysis (FMEA) of Intra OperativeRadiation Therapy (IORT) Treatments With Xoft EBx

D Hoffman*, D Rash , J Urbanic , R Manger , I Dragojevic , UC San Diego, La Jolla, CA


(Tuesday, 7/31/2018) 9:30 AM - 10:00 AM

Room: Exhibit Hall | Forum 7

Purpose: To perform a failure mode and effects analysis (FMEA) for intraoperative radiation therapy (IORT) treatment of early stage breast cancer with the Xoft Axxent electronic brachytherapy (eBx) system.

Methods: A multidisciplinary team conducted an FMEA for IORT breast cancer treatment by developing a process map (Fig. 1). The process map guided the team to identify failure modes for each step in the treatment workflow. Risk Priority Numbers (RPN) were assigned to each failure mode and were calculated as the product of the failure mode’s probability of occurrence (O), severity (S) and lack of detectability (D). Corrective actions were implemented to address the top ten failure modes and a revised process was generated.

Results: The steps with the highest risk failure modes were related to source calibration, use of correct ATLAS, and correct dwell times for a given balloon size and fill volume (Fig. 2). The introduction of additional physics oversight, standardized planning and safety initiatives such as checklists and time-outs reduced the RPNs of these failure modes. High-risk failure modes that could be mitigated with improved hardware and software interlocks were identified.

Conclusion: Source calibration and manual entry of dwell positions for each balloon size - volume combination were the steps with highest RPN values. Integrated treatment planning system and plan verification would increase safety of the treatment and decrease probability of error. This analysis demonstrates the importance of well-designed quality control policies, procedures and oversight in a Xoft IORT eBx program. Unresolved high risk failure modes highlight the need for non-procedural quality initiatives such as improved planning software and more robust hardware interlock systems.


IORT, Brachytherapy, Quality Control


Not Applicable / None Entered.

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