Title:
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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
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Author:
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López Tarjuelo, J.; Bouché Babiloni, Ana; Santos Serra, Agustín; Morillo Macías, Virginia; Calvo Manuel, Felipe A.; Koubychine Merkulov, Youri Alexandrovich; Ferrer Albiach, Carlos
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Other authors:
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Universitat Politècnica de Catalunya. Institut de Tècniques Energètiques; Universitat Politècnica de Catalunya. GREENER - Grup de recerca d'estudis energètics i de les radiacions |
Abstract:
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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. |
Subject(s):
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-Àrees temàtiques de la UPC::Ciències de la salut::Medicina::Medicina interna -Àrees temàtiques de la UPC::Física::Electromagnetisme -Radiotherapy -Medical electronics -Failure mode and effect analysis -Intraoperative electron radiation therapy -Risk analysis -Risk-reduction interventions -Automation -Radioteràpia -Electrònica mèdica |
Rights:
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Attribution-NonCommercial-NoDerivs 3.0 Spain
http://creativecommons.org/licenses/by-nc-nd/3.0/es/ |
Document type:
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Article - Published version Article |
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