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Analysis of Clinical Operation of a Linear Accelerator Using FMEA Method

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S Lee

S Lee1*, D Albani1 , Z Xu2 , J Cantley3 , T Podder1,2 , (1) University Hospitals Cleveland Medical Center, Cleveland, OH, (2) Case Western Reserve University, Cleveland, OH, (3) Genesis Cancer Care Center, Zanesville, OH


SU-I-GPD-T-239 (Sunday, July 30, 2017) 3:00 PM - 6:00 PM Room: Exhibit Hall

Purpose: We upgraded one of our clinical Linacs in 2013 and regularly recorded the operational issues in an attempt to better understanding and improvement of the machine behavior. This study is to evaluate the clinical aspects of the Linac operational errors from the standpoint of both patient safety and socio-economic repercussions using Failure Mode and Effects Analysis (FMEA) methodology.

Methods: The Linac operational errors were recorded at the time of occurrence. Data was collected for the past three years, from June 2013 and to May 2016. Machine faults were defined as any error exhibited by the treatment machine that resulted in reasonable interruption of the clinical workflow. These incorporated a broad spectrum of fault states, from delays that only affected the therapists during machine warm-up time due to software issues up to the loss of multiple treatment days due to the failure of critical accelerator hardware. For each machine fault, the following data were recorded: item/functioning identification, function, failure modes and causes, failure detection method, and repair method. As a part of the FMEA we have considered failure effects (at the local, social, and economic level), and scores for occurrence, severity, and detectability.

Results: Total of 53 reasonable occurrences of Linac downtime were observed. The frequent downtime was attributed to both end-user and field service engineers developing familiarity with a relatively new system. As paths for identifying and troubleshooting issues with the emerging technology became clearer, the frequency of certain MLC faults and their disruptiveness to the treatment schedule (Socio-economic Effects) decreased.

Conclusion: Knowledge gleaned from this study of the Linac provides a framework upon which performance of similar Linacs may be appraised. The FMEA methodology was useful in assessing the critical issues and provided insight into realistic responses in case of unexpected machine failures.

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