Failure mode and effects analysis in a dual-product microsphere brachytherapy environment.

Abstract

We 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. A 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. Between both types of microsphere products, 173 failure mode/effect pairs were identified: 90 for patients, 35 for staff, and 48 for the institution. The SIR-Spheres 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. The 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-Spheres program and our existing TheraSphere program. As new guidelines are made available, and our experience with the SIR-Spheres program increases, we will update the FMEA as an efficient starting point for future improvements.