Failure Mode and Effects Analysis in a Dual-Product Microsphere Brachytherapy Environment

Publication date: Available online 16 March 2016
Source:Practical Radiation Oncology
Author(s): Kelly Cooper Younge, Choonik I. Lee, Jean M. Moran, Mary Feng, Paula Novelli, Joann I. Prisciandaro
PurposeWe performed a failure mode and effects analysis (FMEA) during the addition of a new microspheres product into our existing microsphere brachytherapy program to identify areas for safety improvements.Methods and MaterialsA diverse group of team members from the microsphere program participated in the project to create a process map, identify and score failure modes, and discuss programmatic changes to address the highest-ranking items. We developed custom severity ranking scales for staff- and institution-related failure modes to encompass possible risks that may exist outside of patient-based effects.ResultsFor both types of microsphere products, a total of 173 failure mode / effect pairs were identified: 90 for patients, 35 for staff, and 48 for the institution. The SIR-Sphere program was ranked separately from the Therasphere program because of significant differences in workflow during dose calculation, preparation, and delivery. High-ranking failure modes in each category were addressed with programmatic changes.ConclusionThe FMEA aided in identifying potential risk factors in our microsphere program and allowed a theoretically safer and more efficient design of the workflow and quality assurance for both our new SIR-Sphere program and our existing Therasphere program. As new guidelines are made available, and our experience with the SIR-Sphere program increases, we will update the FMEA as an efficient starting point for future improvements.



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