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Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy

BACKGROUND: A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to the actively scanned proton beam radiotherapy process implemented at CNAO (Centro Nazionale di Adroterapia Oncologica), aiming at preventing accidental exposures to...

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Autores principales: Cantone, Marie Claire, Ciocca, Mario, Dionisi, Francesco, Fossati, Piero, Lorentini, Stefano, Krengli, Marco, Molinelli, Silvia, Orecchia, Roberto, Schwarz, Marco, Veronese, Ivan, Vitolo, Viviana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3679803/
https://www.ncbi.nlm.nih.gov/pubmed/23705626
http://dx.doi.org/10.1186/1748-717X-8-127
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author Cantone, Marie Claire
Ciocca, Mario
Dionisi, Francesco
Fossati, Piero
Lorentini, Stefano
Krengli, Marco
Molinelli, Silvia
Orecchia, Roberto
Schwarz, Marco
Veronese, Ivan
Vitolo, Viviana
author_facet Cantone, Marie Claire
Ciocca, Mario
Dionisi, Francesco
Fossati, Piero
Lorentini, Stefano
Krengli, Marco
Molinelli, Silvia
Orecchia, Roberto
Schwarz, Marco
Veronese, Ivan
Vitolo, Viviana
author_sort Cantone, Marie Claire
collection PubMed
description BACKGROUND: A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to the actively scanned proton beam radiotherapy process implemented at CNAO (Centro Nazionale di Adroterapia Oncologica), aiming at preventing accidental exposures to the patient. METHODS: FMEA was applied to the treatment planning stage and consisted of three steps: i) identification of the involved sub-processes; ii) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system, iii) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. RESULTS: Thirty-four sub-processes were identified, twenty-two of them were judged to be potentially prone to one or more failure modes. A total of forty-four failure modes were recognized, 52% of them characterized by an RPN score equal to 80 or higher. The threshold of 125 for RPN was exceeded in five cases only. The most critical sub-process appeared related to the delineation and correction of artefacts in planning CT data. Failures associated to that sub-process were inaccurate delineation of the artefacts and incorrect proton stopping power assignment to body regions. Other significant failure modes consisted of an outdated representation of the patient anatomy, an improper selection of beam direction and of the physical beam model or dose calculation grid. The main effects of these failures were represented by wrong dose distribution (i.e. deviating from the planned one) delivered to the patient. Additional strategies for risk mitigation, easily and immediately applicable, consisted of a systematic information collection about any known implanted prosthesis directly from each patient and enforcing a short interval time between CT scan and treatment start. Moreover, (i) the investigation of dedicated CT image reconstruction algorithms, (ii) further evaluation of treatment plan robustness and (iii) implementation of independent methods for dose calculation (such as Monte Carlo simulations) may represent novel solutions to increase patient safety. CONCLUSIONS: FMEA is a useful tool for prospective evaluation of patient safety in proton beam radiotherapy. The application of this method to the treatment planning stage lead to identify strategies for risk mitigation in addition to the safety measures already adopted in clinical practice.
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spelling pubmed-36798032013-06-13 Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy Cantone, Marie Claire Ciocca, Mario Dionisi, Francesco Fossati, Piero Lorentini, Stefano Krengli, Marco Molinelli, Silvia Orecchia, Roberto Schwarz, Marco Veronese, Ivan Vitolo, Viviana Radiat Oncol Research BACKGROUND: A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to the actively scanned proton beam radiotherapy process implemented at CNAO (Centro Nazionale di Adroterapia Oncologica), aiming at preventing accidental exposures to the patient. METHODS: FMEA was applied to the treatment planning stage and consisted of three steps: i) identification of the involved sub-processes; ii) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system, iii) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. RESULTS: Thirty-four sub-processes were identified, twenty-two of them were judged to be potentially prone to one or more failure modes. A total of forty-four failure modes were recognized, 52% of them characterized by an RPN score equal to 80 or higher. The threshold of 125 for RPN was exceeded in five cases only. The most critical sub-process appeared related to the delineation and correction of artefacts in planning CT data. Failures associated to that sub-process were inaccurate delineation of the artefacts and incorrect proton stopping power assignment to body regions. Other significant failure modes consisted of an outdated representation of the patient anatomy, an improper selection of beam direction and of the physical beam model or dose calculation grid. The main effects of these failures were represented by wrong dose distribution (i.e. deviating from the planned one) delivered to the patient. Additional strategies for risk mitigation, easily and immediately applicable, consisted of a systematic information collection about any known implanted prosthesis directly from each patient and enforcing a short interval time between CT scan and treatment start. Moreover, (i) the investigation of dedicated CT image reconstruction algorithms, (ii) further evaluation of treatment plan robustness and (iii) implementation of independent methods for dose calculation (such as Monte Carlo simulations) may represent novel solutions to increase patient safety. CONCLUSIONS: FMEA is a useful tool for prospective evaluation of patient safety in proton beam radiotherapy. The application of this method to the treatment planning stage lead to identify strategies for risk mitigation in addition to the safety measures already adopted in clinical practice. BioMed Central 2013-05-24 /pmc/articles/PMC3679803/ /pubmed/23705626 http://dx.doi.org/10.1186/1748-717X-8-127 Text en Copyright © 2013 Cantone et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Cantone, Marie Claire
Ciocca, Mario
Dionisi, Francesco
Fossati, Piero
Lorentini, Stefano
Krengli, Marco
Molinelli, Silvia
Orecchia, Roberto
Schwarz, Marco
Veronese, Ivan
Vitolo, Viviana
Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy
title Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy
title_full Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy
title_fullStr Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy
title_full_unstemmed Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy
title_short Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy
title_sort application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3679803/
https://www.ncbi.nlm.nih.gov/pubmed/23705626
http://dx.doi.org/10.1186/1748-717X-8-127
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