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Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) for Eye Plaque Brachytherapy

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Y Lee

Y Lee*, J Huynh , R Hamilton , Y Kim , University of Arizona, Tucson, AZ


TU-FG-702-6 (Tuesday, August 1, 2017) 1:45 PM - 3:45 PM Room: 702

Purpose: The purpose of this study is to identify potential failure modes (FMs) with high risks and to review and improve our current quality management (QM) program in eye plaque brachytherapy by undertaking failure modes and effects analysis (FMEA) and fault tree analysis (FTA).

Methods: Based on the guidance of American Association of Physicists in Medicine (AAPM) Task Group (TG)-100, process mapping and FMEA were performed for eye plaque brachytherapy. For all identified FMs, risk priority numbers (RPNs) were determined by assigning and multiplying occurrence (O), severity (S) and lack of detectability (D) values (each ranges from 1 to 10) by radiation oncology staff and ophthalmology staff, and then all FMs were sorted by RPN risk scores. Fault tree analysis (FTA) was performed for the major process that had the highest ranked FM.

Results: A total of 13 major processes, 121 sub-process steps and 188 FMs were identified. Plaque assembly was the major process with the highest RPN score. The majority of the potential FMs were caused by human performance errors (85.11%) and among all staff, medical physicist related failure was highest (54.79%) followed by use of defective equipment/tool (6.91%), inadequate training (4.26%), hardware/software failure (2.66%) and inadequate commissioning (1.06%). For 10 highest ranked FMs and plaque assembly, current controls were reviewed and new QM methods were suggested.

Conclusion: To reduce high risks in current clinical practice, we propose to improve quality control (QC) and/or quality assurance (QA) of our current QM program. The QM methods include check or verification and the use of updated checklists for radiation oncology staff, and an independent review and intraoperative ultrasound-guided plaque positioning for ophthalmology staff.

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