Pro-active risk analysis of an in-house developed deep learning based autoplanning tool for breast Volumetric Modulated Arc Therapy.

Background and Purpose: With the increasing amount of in-house created deep learning models in radiotherapy, it is important to know how to minimise the risks associated with the local clinical implementation prior to clinical use. The goal of this study is to give an example of how to identify the risks and find mitigation strategies to reduce these risks in an implemented workflow containing a deep learning based planning tool for breast Volumetric Modulated Arc Therapy. Materials and Methods: The deep learning model ran on a private Google Cloud environment for adequate computational capacity and was integrated into a workflow that could be initiated within the clinical Treatment Planning System (TPS). A proactive Failure Mode and Effect Analysis (FMEA) was conducted by a multidisciplinary team, including physicians, physicists, dosimetrists, technologists, quality managers, and the research and development team. Failure modes categorised as 'Not acceptable' and 'Tolerable' on the risk matrix were further examined to find mitigation strategies. Results: In total, 39 failure modes were defined for the total workflow, divided over four steps. Of these, 33 were deemed 'Acceptable', five 'Tolerable', and one 'Not acceptable'. Mitigation strategies, such as a case-specific Quality Assurance report, additional scripted checks and properties, a pop-up window, and time stamp analysis, reduced the failure modes to two 'Tolerable' and none in the 'Not acceptable' region. Conclusions: The pro-active risk analysis revealed possible risks in the implemented workflow and led to the implementation of mitigation strategies that decreased the risk scores for safer clinical use.