TY - JOUR
T1 - Application of failure mode and effects analysis to intracranial stereotactic radiation surgery by linear accelerator
AU - Masini, Laura
AU - Donis, Laura
AU - Loi, Gianfranco
AU - Mones, Eleonora
AU - Molina, Elisa
AU - Bolchini, Cesare
AU - Krengli, Marco
N1 - Publisher Copyright:
© 2014 American Society for Radiation Oncology.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - Purpose: The aim of this study was to analyze the application of the failure modes and effects analysis (FMEA) to intracranial stereotactic radiation surgery (SRS) by linear accelerator in order to identify the potential failure modes in the process tree and adopt appropriate safety measures to prevent adverse events (AEs) and near-misses, thus improving the process quality. Methods and materials: A working group was set up to perform FMEA for intracranial SRS in the framework of a quality assurance program. FMEA was performed in 4 consecutive tasks: (1) creation of a visual map of the process; (2) identification of possible failure modes; (3) assignment of a risk probability number (RPN) to each failure mode based on tabulated scores of severity, frequency of occurrence and detectability; and (4) identification of preventive measures to minimize the risk of occurrence. Results: The whole SRS procedure was subdivided into 73 single steps; 116 total possible failure modes were identified and a score of severity, occurrence, and detectability was assigned to each. Based on these scores, RPN was calculated for each failure mode thus obtaining values from 1 to 180. In our analysis, 112/116 (96.6%) RPN values were <. 60, 2 (1.7%) between 60 and 125 (63, 70), and 2 (1.7%) >. 125 (135, 180). The 2 highest RPN scores were assigned to the risk of using the wrong collimator's size and incorrect coordinates on the laser target localizer frame. Conclusion: Failure modes and effects analysis is a simple and practical proactive tool for systematic analysis of risks in radiation therapy. In our experience of SRS, FMEA led to the adoption of major changes in various steps of the SRS procedure.
AB - Purpose: The aim of this study was to analyze the application of the failure modes and effects analysis (FMEA) to intracranial stereotactic radiation surgery (SRS) by linear accelerator in order to identify the potential failure modes in the process tree and adopt appropriate safety measures to prevent adverse events (AEs) and near-misses, thus improving the process quality. Methods and materials: A working group was set up to perform FMEA for intracranial SRS in the framework of a quality assurance program. FMEA was performed in 4 consecutive tasks: (1) creation of a visual map of the process; (2) identification of possible failure modes; (3) assignment of a risk probability number (RPN) to each failure mode based on tabulated scores of severity, frequency of occurrence and detectability; and (4) identification of preventive measures to minimize the risk of occurrence. Results: The whole SRS procedure was subdivided into 73 single steps; 116 total possible failure modes were identified and a score of severity, occurrence, and detectability was assigned to each. Based on these scores, RPN was calculated for each failure mode thus obtaining values from 1 to 180. In our analysis, 112/116 (96.6%) RPN values were <. 60, 2 (1.7%) between 60 and 125 (63, 70), and 2 (1.7%) >. 125 (135, 180). The 2 highest RPN scores were assigned to the risk of using the wrong collimator's size and incorrect coordinates on the laser target localizer frame. Conclusion: Failure modes and effects analysis is a simple and practical proactive tool for systematic analysis of risks in radiation therapy. In our experience of SRS, FMEA led to the adoption of major changes in various steps of the SRS procedure.
UR - http://www.scopus.com/inward/record.url?scp=84912521696&partnerID=8YFLogxK
U2 - 10.1016/j.prro.2014.01.006
DO - 10.1016/j.prro.2014.01.006
M3 - Article
SN - 1879-8500
VL - 4
SP - 392
EP - 397
JO - Practical Radiation Oncology
JF - Practical Radiation Oncology
IS - 6
ER -