PURPOSE: Failure mode and effects analysis (FMEA) represents a prospective approach for risk assessment. A multidisciplinary working group of the Italian Association for Medical Physics applied FMEA to electron beam intraoperative radiation therapy (IORT) delivered using mobile linear accelerators, aiming at preventing accidental exposures to the patient. METHODS AND MATERIALS: FMEA was applied to the IORT process, for the stages of the treatment delivery and verification, and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system, based on the product of three parameters (severity, frequency of occurrence and detectability, each ranging from 1 to 10); 3) 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: Twenty-four subprocesses were identified. Ten potential failure modes were found and scored, in terms of RPN, in the range of 42-216. The most critical failure modes consisted of internal shield misalignment, wrong Monitor Unit calculation and incorrect data entry at treatment console. Potential causes of failure included shield displacement, human errors, such as underestimation of CTV extension, mainly because of lack of adequate training and time pressures, failure in the communication between operators, and machine malfunctioning. The main effects of failure were represented by CTV underdose, wrong dose distribution and/or delivery, unintended normal tissue irradiation. As additional safety measures, the utilization of a dedicated staff for IORT, double-checking of MU calculation and data entry and finally implementation of in vivo dosimetry were suggested. CONCLUSIONS: FMEA appeared as a useful tool for prospective evaluation of patient safety in radiotherapy. The application of this method to IORT lead to identify three safety measures for risk mitigation.
PURPOSE: Failure mode and effects analysis (FMEA) represents a prospective approach for risk assessment. A multidisciplinary working group of the Italian Association for Medical Physics applied FMEA to electron beam intraoperative radiation therapy (IORT) delivered using mobile linear accelerators, aiming at preventing accidental exposures to the patient. METHODS AND MATERIALS: FMEA was applied to the IORT process, for the stages of the treatment delivery and verification, and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system, based on the product of three parameters (severity, frequency of occurrence and detectability, each ranging from 1 to 10); 3) 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: Twenty-four subprocesses were identified. Ten potential failure modes were found and scored, in terms of RPN, in the range of 42-216. The most critical failure modes consisted of internal shield misalignment, wrong Monitor Unit calculation and incorrect data entry at treatment console. Potential causes of failure included shield displacement, human errors, such as underestimation of CTV extension, mainly because of lack of adequate training and time pressures, failure in the communication between operators, and machine malfunctioning. The main effects of failure were represented by CTV underdose, wrong dose distribution and/or delivery, unintended normal tissue irradiation. As additional safety measures, the utilization of a dedicated staff for IORT, double-checking of MU calculation and data entry and finally implementation of in vivo dosimetry were suggested. CONCLUSIONS: FMEA appeared as a useful tool for prospective evaluation of patient safety in radiotherapy. The application of this method to IORT lead to identify three safety measures for risk mitigation.
Authors: M Saiful Huq; Benedick A Fraass; Peter B Dunscombe; John P Gibbons; Geoffrey S Ibbott; Arno J Mundt; Sasa Mutic; Jatinder R Palta; Frank Rath; Bruce R Thomadsen; Jeffrey F Williamson; Ellen D Yorke Journal: Med Phys Date: 2016-07 Impact factor: 4.071
Authors: Antonio L Damato; Larissa J Lee; Mandar S Bhagwat; Ivan Buzurovic; Robert A Cormack; Susan Finucane; Jorgen L Hansen; Desmond A O'Farrell; Alecia Offiong; Una Randall; Scott Friesen; Akila N Viswanathan Journal: Brachytherapy Date: 2015-01-06 Impact factor: 2.362
Authors: Jacqueline Tonigan Faught; Peter A Balter; Jennifer L Johnson; Stephen F Kry; Laurence E Court; Francesco C Stingo; David S Followill Journal: Med Phys Date: 2017-10-19 Impact factor: 4.071
Authors: Ivan Veronese; Elena De Martin; Anna Stefania Martinotti; Maria Luisa Fumagalli; Cristina Vite; Irene Redaelli; Tiziana Malatesta; Pietro Mancosu; Giancarlo Beltramo; Laura Fariselli; Marie Claire Cantone Journal: Radiat Oncol Date: 2015-06-13 Impact factor: 3.481
Authors: Bradley W Schuller; Angi Burns; Elizabeth A Ceilley; Alan King; Joan LeTourneau; Alexander Markovic; Lynda Sterkel; Brigid Taplin; Jennifer Wanner; Jeffrey M Albert Journal: J Appl Clin Med Phys Date: 2017-09-25 Impact factor: 2.102
Authors: Sara Broggi; Marie Claire Cantone; Anna Chiara; Nadia Di Muzio; Barbara Longobardi; Paola Mangili; Ivan Veronese Journal: J Appl Clin Med Phys Date: 2013-09-06 Impact factor: 2.102