PMID- 25465728
OWN - NLM
STAT- MEDLINE
DCOM- 20150831
LR  - 20181202
IS  - 1879-0887 (Electronic)
IS  - 0167-8140 (Linking)
VI  - 113
IP  - 2
DP  - 2014 Nov
TI  - 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.
PG  - 283-9
LID - S0167-8140(14)00491-5 [pii]
LID - 10.1016/j.radonc.2014.11.012 [doi]
AB  - BACKGROUND AND PURPOSE: 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. MATERIAL AND 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.
CI  - Copyright (c) 2014 Elsevier Ireland Ltd. All rights reserved.
FAU - Lopez-Tarjuelo, Juan
AU  - Lopez-Tarjuelo J
AD  - Servicio de Radiofisica y Proteccion Radiologica, Consorcio Hospitalario 
      Provincial de Castellon, Castellon de la Plana, Spain. Electronic address: 
      lopez_juatar@gva.es.
FAU - Bouche-Babiloni, Ana
AU  - Bouche-Babiloni A
AD  - Servicio de Oncologia Radioterapica, Consorcio Hospitalario Provincial de 
      Castellon, Castellon de la Plana, Spain.
FAU - Santos-Serra, Agustin
AU  - Santos-Serra A
AD  - Servicio de Radiofisica y Proteccion Radiologica, Consorcio Hospitalario 
      Provincial de Castellon, Castellon de la Plana, Spain.
FAU - Morillo-Macias, Virginia
AU  - Morillo-Macias V
AD  - Servicio de Oncologia Radioterapica, Consorcio Hospitalario Provincial de 
      Castellon, Castellon de la Plana, Spain.
FAU - Calvo, Felipe A
AU  - Calvo FA
AD  - Departamento de Oncologia, Hospital General Universitario Gregorio Maranon 
      Madrid, Spain; Instituto de Investigacion Sanitaria Gregorio Maranon, Madrid, 
      Spain; Facultad de Medicina, Universidad Complutense de Madrid, Spain.
FAU - Kubyshin, Yuri
AU  - Kubyshin Y
AD  - Instituto de Tecnicas Energeticas, Universidad Politecnica de Cataluna, 
      Barcelona, Spain.
FAU - Ferrer-Albiach, Carlos
AU  - Ferrer-Albiach C
AD  - Servicio de Oncologia Radioterapica, Consorcio Hospitalario Provincial de 
      Castellon, Castellon de la Plana, Spain; Facultad de Medicina, Universidad 
      Cardenal Herrera-CEU, Castellon de la Plana, Spain.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20141124
PL  - Ireland
TA  - Radiother Oncol
JT  - Radiotherapy and oncology : journal of the European Society for Therapeutic 
      Radiology and Oncology
JID - 8407192
SB  - IM
MH  - Automation
MH  - Electrons
MH  - Humans
MH  - *Intraoperative Care
MH  - *Radiotherapy Planning, Computer-Assisted
MH  - Risk
MH  - Risk Management
MH  - Risk Reduction Behavior
OTO - NOTNLM
OT  - Automation
OT  - Double check
OT  - Failure mode and effect analysis
OT  - Intraoperative electron radiation therapy
OT  - Risk analysis
OT  - Risk-reduction interventions
EDAT- 2014/12/04 06:00
MHDA- 2015/09/01 06:00
CRDT- 2014/12/04 06:00
PHST- 2014/08/04 00:00 [received]
PHST- 2014/11/05 00:00 [revised]
PHST- 2014/11/08 00:00 [accepted]
PHST- 2014/12/04 06:00 [entrez]
PHST- 2014/12/04 06:00 [pubmed]
PHST- 2015/09/01 06:00 [medline]
AID - S0167-8140(14)00491-5 [pii]
AID - 10.1016/j.radonc.2014.11.012 [doi]
PST - ppublish
SO  - Radiother Oncol. 2014 Nov;113(2):283-9. doi: 10.1016/j.radonc.2014.11.012. Epub 
      2014 Nov 24.