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

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.