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Background: Use of a linear accelerator in ultra-high dose rate (UHDR) modecan provide a conduit for wider access to UHDR FLASH effects, sparing normaltissue, but care needs to be taken in the use of such systems to ensure errorsare minimized.  Purpose: Failure Modes and Effects Analysis (FMEA) was carried out in a teamthat has been involved in converting a LINAC between clinical use and UHDRexperimental mode for more than one year, following the proposed methods ofTG100.  Methods: A team of 9 professionals with extensive experience were polled tooutline the process map and workflow for analysis, and developed fault treesfor potential errors, as well as failure modes that would results. The teamscored the categories of severity magnitude (S), occurrence likelihood (O), anddetectability potential (D) in a scale of 1 to 10, so that a risk prioritynumber (RPN=S*O*D) could be assessed for each.  Results: A total of 46 potential failure modes were identified, including 5with RPN>100. These failure modes involved 1) patient set up, 2) gatingmechanisms in delivery, and 3) detector in the beam stop mechanism. Identifiedmethods to mitigate errors included 1) use of a checklist post conversion, 2)use of robust radiation detectors, 3) automation of QA and beam consistencychecks, and 4) implementation of surface guidance during beam delivery.  Conclusions: The FMEA process was considered critically important in thissetting of a new use of a LINAC, and the expert team developed a higher levelof confidence in the ability to safely move UHDR LINAC use towards expandedresearch access.

Failure Mode and Effects Analysis (FMEA) for Experimental Use of FLASH on a Clinical Accelerator