Purpose: The recently introduced Varian Ethos system allows adjusting radiotherapy treatment plans to anatomical changes on a daily basis. The system uses artificial intelligence to speed up the process of creating adapted plans, comes with its own software solutions and requires a substantially different workflow. A detailed analysis of possible risks of the associated workflow is presented.
Methods: A prospective risk analysis of the adaptive workflow with the Ethos system was performed using Failure Modes and Effects Analysis (FMEA). An interprofessional team collected possible adverse events and evaluated their severity as well as their chance of occurrence and detectability. Measures to reduce the risks were discussed.
Results: A total of 122 events were identified, and scored. Within the 20 events with the highest-ranked risks, the following were identified: Challenges due to the stand-alone software solution with very limited connectivity to the existing record and verify software and digital patient file, unfamiliarity with the new software and its limitations and the adaption process relying on results obtained by artificial intelligence. The risk analysis led to the implementation of additional quality assurance measures in the workflow.
Conclusions: The thorough analysis of the risks associated with the new treatment technique was the basis for designing details of the workflow. The analysis also revealed challenges to be addressed by both, the vendor and customers. On the vendor side, this includes improving communication between their different software solutions. On the customer side, this especially includes establishing validation strategies to monitor the results of the black box adaption process making use of artificial intelligence.
Keywords: Artificial intelligence; Ethos; Online adaptive radiotherapy; Risk analysis.
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