title: Failure mode and effect analysis oriented to risk-reduction interventions in intraoperative electron radiation therapy: the specific impact of patient transportation, automation, and treatment planning availability.
abstract: OBJECTIVE
  Industrial companies use failure mode and effect analysis (FMEA) to improve quality. Our objective was to describe an FMEA and subsequent interventions for an automated intraoperative electron radiotherapy (IOERT) procedure with computed tomography simulation, pre-planning, and a fixed conventional linear accelerator.
  
  
  METHODS
  A process map, an FMEA, and a fault tree analysis are reported. The equipment considered was the radiance treatment planning system (TPS), the Elekta Precise linac, and TN-502RDM-H metal-oxide-semiconductor-field-effect transistor in vivo dosimeters. Computerized order-entry and treatment-automation were also analyzed.
  
  
  RESULTS
  Fifty-seven potential modes and effects were identified and classified into 'treatment cancellation' and 'delivering an unintended dose'. They were graded from 'inconvenience' or 'suboptimal treatment' to 'total cancellation' or 'potentially wrong' or 'very wrong administered dose', although these latter effects were never experienced. Risk priority numbers (RPNs) ranged from 3 to 324 and totaled 4804. After interventions such as double checking, interlocking, automation, and structural changes the final total RPN was reduced to 1320.
  
  
  CONCLUSIONS
  FMEA is crucial for prioritizing risk-reduction interventions. In a semi-surgical procedure like IOERT double checking has the potential to reduce risk and improve quality. Interlocks and automation should also be implemented to increase the safety of the procedure.
authors.affiliation: Servicio de Radiofísica y Protección Radiológica, Consorcio Hospitalario Provincial de Castellón, Castellón de la Plana, Spain. Electronic address: lopez_juatar@gva.es.
authors.forename: Juan
authors.initials: J
authors.lastname: López-Tarjuelo
authors.affiliation: Servicio de Oncología Radioterápica, Consorcio Hospitalario Provincial de Castellón, Castellón de la Plana, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Bouché-Babiloni
authors.affiliation: Servicio de Radiofísica y Protección Radiológica, Consorcio Hospitalario Provincial de Castellón, Castellón de la Plana, Spain.
authors.forename: Agustín
authors.initials: A
authors.lastname: Santos-Serra
authors.affiliation: Servicio de Oncología Radioterápica, Consorcio Hospitalario Provincial de Castellón, Castellón de la Plana, Spain.
authors.forename: Virginia
authors.initials: V
authors.lastname: Morillo-Macías
authors.affiliation: Departamento de Oncología, Hospital General Universitario Gregorio Marañón Madrid, Spain; Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; Facultad de Medicina, Universidad Complutense de Madrid, Spain.
authors.forename: Felipe A
authors.initials: FA
authors.lastname: Calvo
authors.affiliation: Instituto de Técnicas Energéticas, Universidad Politécnica de Cataluña, Barcelona, Spain.
authors.forename: Yuri
authors.initials: Y
authors.lastname: Kubyshin
authors.affiliation: Servicio de Oncología Radioterápica, Consorcio Hospitalario Provincial de Castellón, Castellón de la Plana, Spain; Facultad de Medicina, Universidad Cardenal Herrera-CEU, Castellón de la Plana, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Ferrer-Albiach
mesh_terms: D001331:Automation; D004583:Electrons; D006801:Humans; D007430:Intraoperative Care; D011880:Radiotherapy Planning, Computer-Assisted; D012306:Risk; D012308:Risk Management; D040242:Risk Reduction Behavior
keywords: Automation; Double check; Failure mode and effect analysis; Intraoperative electron radiation therapy; Risk analysis; Risk-reduction interventions