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Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery

PURPOSE: Gamma Knife radiosurgery is a highly precise and accurate treatment technique for treating brain diseases with low risk of serious error that nevertheless could potentially be reduced. We applied the AAPM Task Group 100 recommended failure modes and effects analysis (FMEA) tool to develop a...

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Autores principales: Xu, Andy Yuanguang, Bhatnagar, Jagdish, Bednarz, Greg, Flickinger, John, Arai, Yoshio, Vacsulka, Jonet, Feng, Wenzheng, Monaco, Edward, Niranjan, Ajay, Lunsford, L. Dade, Huq, M. Saiful
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5689925/
https://www.ncbi.nlm.nih.gov/pubmed/29082599
http://dx.doi.org/10.1002/acm2.12205
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author Xu, Andy Yuanguang
Bhatnagar, Jagdish
Bednarz, Greg
Flickinger, John
Arai, Yoshio
Vacsulka, Jonet
Feng, Wenzheng
Monaco, Edward
Niranjan, Ajay
Lunsford, L. Dade
Huq, M. Saiful
author_facet Xu, Andy Yuanguang
Bhatnagar, Jagdish
Bednarz, Greg
Flickinger, John
Arai, Yoshio
Vacsulka, Jonet
Feng, Wenzheng
Monaco, Edward
Niranjan, Ajay
Lunsford, L. Dade
Huq, M. Saiful
author_sort Xu, Andy Yuanguang
collection PubMed
description PURPOSE: Gamma Knife radiosurgery is a highly precise and accurate treatment technique for treating brain diseases with low risk of serious error that nevertheless could potentially be reduced. We applied the AAPM Task Group 100 recommended failure modes and effects analysis (FMEA) tool to develop a risk‐based quality management program for Gamma Knife radiosurgery. METHODS: A team consisting of medical physicists, radiation oncologists, neurosurgeons, radiation safety officers, nurses, operating room technologists, and schedulers at our institution and an external physicist expert on Gamma Knife was formed for the FMEA study. A process tree and a failure mode table were created for the Gamma Knife radiosurgery procedures using the Leksell Gamma Knife Perfexion and 4C units. Three scores for the probability of occurrence (O), the severity (S), and the probability of no detection for failure mode (D) were assigned to each failure mode by 8 professionals on a scale from 1 to 10. An overall risk priority number (RPN) for each failure mode was then calculated from the averaged O, S, and D scores. The coefficient of variation for each O, S, or D score was also calculated. The failure modes identified were prioritized in terms of both the RPN scores and the severity scores. RESULTS: The established process tree for Gamma Knife radiosurgery consists of 10 subprocesses and 53 steps, including a subprocess for frame placement and 11 steps that are directly related to the frame‐based nature of the Gamma Knife radiosurgery. Out of the 86 failure modes identified, 40 Gamma Knife specific failure modes were caused by the potential for inappropriate use of the radiosurgery head frame, the imaging fiducial boxes, the Gamma Knife helmets and plugs, the skull definition tools as well as other features of the GammaPlan treatment planning system. The other 46 failure modes are associated with the registration, imaging, image transfer, contouring processes that are common for all external beam radiation therapy techniques. The failure modes with the highest hazard scores are related to imperfect frame adaptor attachment, bad fiducial box assembly, unsecured plugs/inserts, overlooked target areas, and undetected machine mechanical failure during the morning QA process. CONCLUSIONS: The implementation of the FMEA approach for Gamma Knife radiosurgery enabled deeper understanding of the overall process among all professionals involved in the care of the patient and helped identify potential weaknesses in the overall process. The results of the present study give us a basis for the development of a risk based quality management program for Gamma Knife radiosurgery.
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spelling pubmed-56899252018-04-02 Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery Xu, Andy Yuanguang Bhatnagar, Jagdish Bednarz, Greg Flickinger, John Arai, Yoshio Vacsulka, Jonet Feng, Wenzheng Monaco, Edward Niranjan, Ajay Lunsford, L. Dade Huq, M. Saiful J Appl Clin Med Phys Radiation Oncology Physics PURPOSE: Gamma Knife radiosurgery is a highly precise and accurate treatment technique for treating brain diseases with low risk of serious error that nevertheless could potentially be reduced. We applied the AAPM Task Group 100 recommended failure modes and effects analysis (FMEA) tool to develop a risk‐based quality management program for Gamma Knife radiosurgery. METHODS: A team consisting of medical physicists, radiation oncologists, neurosurgeons, radiation safety officers, nurses, operating room technologists, and schedulers at our institution and an external physicist expert on Gamma Knife was formed for the FMEA study. A process tree and a failure mode table were created for the Gamma Knife radiosurgery procedures using the Leksell Gamma Knife Perfexion and 4C units. Three scores for the probability of occurrence (O), the severity (S), and the probability of no detection for failure mode (D) were assigned to each failure mode by 8 professionals on a scale from 1 to 10. An overall risk priority number (RPN) for each failure mode was then calculated from the averaged O, S, and D scores. The coefficient of variation for each O, S, or D score was also calculated. The failure modes identified were prioritized in terms of both the RPN scores and the severity scores. RESULTS: The established process tree for Gamma Knife radiosurgery consists of 10 subprocesses and 53 steps, including a subprocess for frame placement and 11 steps that are directly related to the frame‐based nature of the Gamma Knife radiosurgery. Out of the 86 failure modes identified, 40 Gamma Knife specific failure modes were caused by the potential for inappropriate use of the radiosurgery head frame, the imaging fiducial boxes, the Gamma Knife helmets and plugs, the skull definition tools as well as other features of the GammaPlan treatment planning system. The other 46 failure modes are associated with the registration, imaging, image transfer, contouring processes that are common for all external beam radiation therapy techniques. The failure modes with the highest hazard scores are related to imperfect frame adaptor attachment, bad fiducial box assembly, unsecured plugs/inserts, overlooked target areas, and undetected machine mechanical failure during the morning QA process. CONCLUSIONS: The implementation of the FMEA approach for Gamma Knife radiosurgery enabled deeper understanding of the overall process among all professionals involved in the care of the patient and helped identify potential weaknesses in the overall process. The results of the present study give us a basis for the development of a risk based quality management program for Gamma Knife radiosurgery. John Wiley and Sons Inc. 2017-10-29 /pmc/articles/PMC5689925/ /pubmed/29082599 http://dx.doi.org/10.1002/acm2.12205 Text en © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine. This is an open access article under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Radiation Oncology Physics
Xu, Andy Yuanguang
Bhatnagar, Jagdish
Bednarz, Greg
Flickinger, John
Arai, Yoshio
Vacsulka, Jonet
Feng, Wenzheng
Monaco, Edward
Niranjan, Ajay
Lunsford, L. Dade
Huq, M. Saiful
Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery
title Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery
title_full Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery
title_fullStr Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery
title_full_unstemmed Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery
title_short Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery
title_sort failure modes and effects analysis (fmea) for gamma knife radiosurgery
topic Radiation Oncology Physics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5689925/
https://www.ncbi.nlm.nih.gov/pubmed/29082599
http://dx.doi.org/10.1002/acm2.12205
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