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Title: WE-G-BRA-08: Failure Modes and Effects Analysis (FMEA) for Gamma Knife Radiosurgery

Abstract

Purpose: To perform a failure modes and effects analysis (FMEA) study for Gamma Knife (GK) radiosurgery processes at our institution based on our experience with the treatment of more than 13,000 patients. Methods: A team consisting of medical physicists, nurses, radiation oncologists, neurosurgeons at the University of Pittsburgh Medical Center and an external physicist expert was formed for the FMEA study. A process tree and a failure mode table were created for the GK procedures using the Leksell GK Perfexion and 4C units. Three scores for the probability of occurrence (O), the severity (S), and the probability of no detection (D) for failure modes were assigned to each failure mode by each professional on a scale from 1 to 10. The risk priority number (RPN) for each failure mode was then calculated (RPN = OxSxD) as the average scores from all data sets collected. Results: The established process tree for GK radiosurgery consists of 10 sub-processes and 53 steps, including a sub-process for frame placement and 11 steps that are directly related to the frame-based nature of the GK radiosurgery. Out of the 86 failure modes identified, 40 failure modes are GK specific, caused by the potential for inappropriate usemore » of the radiosurgery head frame, the imaging fiducial boxes, the GK helmets and plugs, and 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 radiation therapy techniques. The failure modes with the highest hazard scores are related to imperfect frame adaptor attachment, bad fiducial box assembly, overlooked target areas, inaccurate previous treatment information and excessive patient movement during MRI scan. Conclusion: 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.« less

Authors:
; ; ; ; ;  [1]; ; ; ;  [2];  [3]
  1. Department of Radiation Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, PA (United States)
  2. Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA (United States)
  3. Dept of Radiation Oncology, New York Presbyterian Hospital/Columbia Univ Medical Center, New York, NY (United States)
Publication Date:
OSTI Identifier:
22572276
Resource Type:
Journal Article
Journal Name:
Medical Physics
Additional Journal Information:
Journal Volume: 42; Journal Issue: 6; Other Information: (c) 2015 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0094-2405
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; 61 RADIATION PROTECTION AND DOSIMETRY; BIOMEDICAL RADIOGRAPHY; FAILURES; HAZARDS; IMAGES; MEDICAL PERSONNEL; NMR IMAGING; PATIENTS; RADIOTHERAPY; SURGERY

Citation Formats

Xu, Y, Bhatnagar, J, Bednarz, G, Flickinger, J, Arai, Y, Huq, M Saiful, Vacsulka, J, Monaco, E, Niranjan, A, Lunsford, L Dade, and Feng, W. WE-G-BRA-08: Failure Modes and Effects Analysis (FMEA) for Gamma Knife Radiosurgery. United States: N. p., 2015. Web. doi:10.1118/1.4926078.
Xu, Y, Bhatnagar, J, Bednarz, G, Flickinger, J, Arai, Y, Huq, M Saiful, Vacsulka, J, Monaco, E, Niranjan, A, Lunsford, L Dade, & Feng, W. WE-G-BRA-08: Failure Modes and Effects Analysis (FMEA) for Gamma Knife Radiosurgery. United States. doi:10.1118/1.4926078.
Xu, Y, Bhatnagar, J, Bednarz, G, Flickinger, J, Arai, Y, Huq, M Saiful, Vacsulka, J, Monaco, E, Niranjan, A, Lunsford, L Dade, and Feng, W. Mon . "WE-G-BRA-08: Failure Modes and Effects Analysis (FMEA) for Gamma Knife Radiosurgery". United States. doi:10.1118/1.4926078.
@article{osti_22572276,
title = {WE-G-BRA-08: Failure Modes and Effects Analysis (FMEA) for Gamma Knife Radiosurgery},
author = {Xu, Y and Bhatnagar, J and Bednarz, G and Flickinger, J and Arai, Y and Huq, M Saiful and Vacsulka, J and Monaco, E and Niranjan, A and Lunsford, L Dade and Feng, W},
abstractNote = {Purpose: To perform a failure modes and effects analysis (FMEA) study for Gamma Knife (GK) radiosurgery processes at our institution based on our experience with the treatment of more than 13,000 patients. Methods: A team consisting of medical physicists, nurses, radiation oncologists, neurosurgeons at the University of Pittsburgh Medical Center and an external physicist expert was formed for the FMEA study. A process tree and a failure mode table were created for the GK procedures using the Leksell GK Perfexion and 4C units. Three scores for the probability of occurrence (O), the severity (S), and the probability of no detection (D) for failure modes were assigned to each failure mode by each professional on a scale from 1 to 10. The risk priority number (RPN) for each failure mode was then calculated (RPN = OxSxD) as the average scores from all data sets collected. Results: The established process tree for GK radiosurgery consists of 10 sub-processes and 53 steps, including a sub-process for frame placement and 11 steps that are directly related to the frame-based nature of the GK radiosurgery. Out of the 86 failure modes identified, 40 failure modes are GK specific, caused by the potential for inappropriate use of the radiosurgery head frame, the imaging fiducial boxes, the GK helmets and plugs, and 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 radiation therapy techniques. The failure modes with the highest hazard scores are related to imperfect frame adaptor attachment, bad fiducial box assembly, overlooked target areas, inaccurate previous treatment information and excessive patient movement during MRI scan. Conclusion: 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.},
doi = {10.1118/1.4926078},
journal = {Medical Physics},
issn = {0094-2405},
number = 6,
volume = 42,
place = {United States},
year = {2015},
month = {6}
}