title: Failure mode and effects analysis in a dual-product microsphere brachytherapy environment.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiation Oncology, University of Michigan Hospitals, Ann Arbor, Michigan. Electronic address: kyounge@med.umich.edu.
authors.forename: Kelly Cooper
authors.initials: KC
authors.lastname: Younge
authors.affiliation: Department of Radiation Oncology, University of Michigan Hospitals, Ann Arbor, Michigan.
authors.forename: Choonik
authors.initials: C
authors.lastname: Lee
authors.affiliation: Department of Radiation Oncology, University of Michigan Hospitals, Ann Arbor, Michigan.
authors.forename: Jean M
authors.initials: JM
authors.lastname: Moran
authors.affiliation: Department of Radiation Oncology, University of Michigan Hospitals, Ann Arbor, Michigan.
authors.forename: Mary
authors.initials: M
authors.lastname: Feng
authors.affiliation: Department of Interventional Radiology, University of Michigan Hospitals, Ann Arbor, Michigan.
authors.forename: Paula
authors.initials: P
authors.lastname: Novelli
authors.affiliation: Department of Radiation Oncology, University of Michigan Hospitals, Ann Arbor, Michigan.
authors.forename: Joann I
authors.initials: JI
authors.lastname: Prisciandaro
mesh_terms: D001918:Brachytherapy / Q000379:methods*; D000067495:Healthcare Failure Mode and Effect Analysis; D006801:Humans; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000532:radiotherapy*; D008863:Microspheres; D011785:Quality Assurance, Health Care; D019275:Radiopharmaceuticals; D000072098:Single Photon Emission Computed Tomography Computed Tomography; D013668:Technetium Tc 99m Aggregated Albumin; D057188:Workflow
chemical_list: D019275:Radiopharmaceuticals; D013668:Technetium Tc 99m Aggregated Albumin