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Failure Mode and Effects Analysis in the First Clinical Implementation of a Novel Stereotactic Breast Radiotherapy Device: GammaPod™

S Mossahebi

S Mossahebi1*, S Feigenberg1 , E Nichols1 , Y Niu2 , S Becker1 , K Prado1 , B Yi1 , C Yu1,2 , Y Mutaf1 , (1) University of Maryland School of Medicine, Baltimore, MD, (2) Xcision Medical Systems, Rockville, MD,


WE-H-BRC-3 (Wednesday, August 3, 2016) 4:30 PM - 6:00 PM Room: Ballroom C

Purpose: GammaPod™, the first stereotactic radiotherapy device for early stage breast cancer treatment, has been recently installed and commissioned at our institution. A multidisciplinary working group applied the failure mode and effects analysis (FMEA) approach to perform a risk analysis.

Methods: FMEA was applied to the GammaPod™ treatment process by: 1) generating process maps for each stage of treatment; 2) identifying potential failure modes and outlining their causes and effects; 3) scoring the potential failure modes using the risk priority number (RPN) system based on the product of severity, frequency of occurrence, and detectability (ranging 1-10). An RPN of higher than 150 was set as the threshold for minimal concern of risk. For these high-risk failure modes, potential quality assurance procedures and risk control techniques have been proposed. A new set of severity, occurrence, and detectability values were re-assessed in presence of the suggested mitigation strategies.

Results: In the single-day image-and-treat workflow, 19, 22, and 27 sub-processes were identified for the stages of simulation, treatment planning, and delivery processes, respectively. During the simulation stage, 38 potential failure modes were found and scored, in terms of RPN, in the range of 9-392. 34 potential failure modes were analyzed in treatment planning with a score range of 16-200. For the treatment delivery stage, 47 potential failure modes were found with an RPN score range of 16-392. The most critical failure modes consisted of breast-cup pressure loss and incorrect target localization due to patient upper-body alignment inaccuracies. The final RPN score of these failure modes based on recommended actions were assessed to be below 150.

Conclusion: FMEA risk analysis technique was applied to the treatment process of GammaPod™, a new stereotactic radiotherapy technology. Application of systematic risk analysis methods is projected to lead to improved quality of GammaPod™ treatments.

Funding Support, Disclosures, and Conflict of Interest: Ying Niu and Cedric Yu are affiliated with Xcision Medical Systems.

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