Program Information
FMEA Quality Management Framework for Small Animal Image-Guided Radiotherapy Based On the TG-100 Methodology
Y Poirier1*, M Bazalova-Carter2 , C Johnstone2 , A Anvari1 , A Sawant1 , (1) University of Maryland School of Medicine, Baltimore, MD, (2) University of Victoria, Victoria, BC
Presentations
MO-DE-605-3 (Monday, July 31, 2017) 1:45 PM - 3:45 PM Room: 605
Purpose: Image-guided small animal irradiators capable of sub-millimeter accuracy are increasingly used in pre-clinical research. Unlike conventional radiotherapy, there is no consensus on quality assurance (QA), and physics resources are scarce and inconsistent. Furthermore, new technologies from various manufacturers are rapidly entering the field. For these reasons, developing a conventional, prescriptive QA program is unfeasible. To address this, we applied the AAPM’s Task Group 100 (TG-100) failure mode effects analysis (FMEA) methodology to identify the main failure modes specific to small animal irradiators, and prospectively and efficiently guide the development of QA protocols.
Methods: Conducting a FMEA for small animal irradiators required a change in paradigm from the clinical to the pre-clinical research environment. To this end, we created a new adverse effects severity table specific to small animal irradiators. We also created a process tree outlining the major steps in a general small-animal irradiation study by modifying the clinical IMRT process tree from TG-100, adding/removing steps specific to pre-clinical studies. We used this process tree to create and distribute a survey to five end-users in two institutions using image-guided small animal irradiators. Users were asked to rate failure modes in terms of occurrence, severity, and detectability, and propose their own. These were used to calculate risk probability numbers (RPN), which we used to stratify the most dangerous failure modes.
Results: The survey responses indicated a number of high risk (RPN>125) failure modes specific to small animal irradiators. Chief amongst these was the risk of incorrectly irradiating a number of animals due to the lack of interlocks asserting the correct filter/collimator settings on some irradiator models.
Conclusion: The first steps of a FMEA were applied to image-guided small animal irradiators following the TG-100 methodology. Future work will focus on expanding the breadth and scope of user surveys.
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