title: Application of failure mode and effects analysis to intracranial stereotactic radiation surgery by linear accelerator.
abstract: OBJECTIVE
  The aim of this study was to analyze the application of the failure modes and effects analysis (FMEA) to intracranial stereotactic radiation surgery (SRS) by linear accelerator in order to identify the potential failure modes in the process tree and adopt appropriate safety measures to prevent adverse events (AEs) and near-misses, thus improving the process quality.
  
  
  METHODS
  A working group was set up to perform FMEA for intracranial SRS in the framework of a quality assurance program. FMEA was performed in 4 consecutive tasks: (1) creation of a visual map of the process; (2) identification of possible failure modes; (3) assignment of a risk probability number (RPN) to each failure mode based on tabulated scores of severity, frequency of occurrence and detectability; and (4) identification of preventive measures to minimize the risk of occurrence.
  
  
  RESULTS
  The whole SRS procedure was subdivided into 73 single steps; 116 total possible failure modes were identified and a score of severity, occurrence, and detectability was assigned to each. Based on these scores, RPN was calculated for each failure mode thus obtaining values from 1 to 180. In our analysis, 112/116 (96.6%) RPN values were <60, 2 (1.7%) between 60 and 125 (63, 70), and 2 (1.7%) >125 (135, 180). The 2 highest RPN scores were assigned to the risk of using the wrong collimator's size and incorrect coordinates on the laser target localizer frame.
  
  
  CONCLUSIONS
  Failure modes and effects analysis is a simple and practical proactive tool for systematic analysis of risks in radiation therapy. In our experience of SRS, FMEA led to the adoption of major changes in various steps of the SRS procedure.
authors.affiliation: Department of Radiotherapy, University Hospital Maggiore della Carità, Novara, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Masini
authors.affiliation: Department of Radiotherapy, University Hospital Maggiore della Carità, Novara, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Donis
authors.affiliation: Department of Medical Physics, University Hospital Maggiore della Carità, Novara, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Loi
authors.affiliation: Department of Medical Physics, University Hospital Maggiore della Carità, Novara, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Mones
authors.affiliation: Department of Radiotherapy, University Hospital Maggiore della Carità, Novara, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Molina
authors.affiliation: Department of Radiotherapy, University Hospital Maggiore della Carità, Novara, Italy.
authors.forename: Cesare
authors.initials: C
authors.lastname: Bolchini
authors.affiliation: Department of Radiotherapy, University Hospital Maggiore della Carità, Novara, Italy; Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy. Electronic address: krengli@med.unipmn.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Krengli
mesh_terms: D001932:Brain Neoplasms / Q000473:pathology / Q000601:surgery*; D006801:Humans; D010315:Particle Accelerators; D016634:Radiosurgery / Q000295:instrumentation* / Q000379:methods*; D018570:Risk Assessment