FMECA Application to Intraoperative Electron Beam Radiotherapy Procedure As a Quality Method to Prevent and Reduce Patient’s Risk in Conservative Surgery for Breast Cancer

Abstract

IntroductionFailure Mode Effects and Criticalities Analysis (FMECA) represents a prospective method for risk assessment in complex medical practices. Our objective was to describe the application of FMECA approach to intraoperative electron beam radiotherapy (IOERT), delivered using a mobile linear accelerator, for the treatment of early breast cancer as an anticipated boost.Materials and methodsA multidisciplinary Working Group, including several different professional profiles, was created before the beginning of clinical practice in 2012, with the purpose of writing the Flow Chart and applying the FMECA methodology to IOERT procedure. Several criticalities were identified a priori in the different steps of the procedure and a list of all potential failure modes (FMs) was drafted and ranked using the risk priority number (RPN) scoring system, based on the product of three parameters: severity, occurrence, and detectability (score between 1 and 5). The actions aimed at reducing the risk were then defined by the Working Group and the risk analysis was repeated in 2014 and in 2016, in order to assess the improvement achieved.ResultsFifty-one FMs were identified, which represented the issues prospectively investigated according to the FMECA methodology. Considering a set threshold of 30, the evaluated RPNs show that 33 out of 51 FMs are critical; 6 are included in the moderate risk class (RPN: 31–40); 16 in the intermediate risk class (RPN: 41–50), and 11 in the high risk class (RPN: >50).DiscussionThe most critical steps concerned the surgical procedure and IOERT set-up. The introduction of the corrective actions into the clinical practice achieved the reduction of the RPNs in the re-analysis of the FMECA worksheet after 2 and 4 years, respectively.ConclusionFMECA proved to be a useful tool for prospective evaluation of potential failures in IOERT and contributed to optimize patient safety and to improve risk management culture among all the professionals of the Working Group.

State of the art in breast intraoperative electron radiation therapy after intraoperative ultrasound introduction

“…20 The process leading to intraoperative radiation treatment, without TPS, is mostly the result of a sequence of manually handled actions involving the Surgeon, the Radiation Oncologist, the Medical Physicist, the Technicians and the Nurses of the operating room. 9,11 Some papers examined the importance of risk assessment analysis applied to IOERT procedure: in the Italian publications a dedicated mobile Linac was used, while in the Spanish analysis the irradiation was performed with a conventional Linac. 11,16,17 In all of the studies the highest risk was associated with the alignment of the shielding disk, as it was observed in our experience.…”

“…9,11 Some papers examined the importance of risk assessment analysis applied to IOERT procedure: in the Italian publications a dedicated mobile Linac was used, while in the Spanish analysis the irradiation was performed with a conventional Linac. 11,16,17 In all of the studies the highest risk was associated with the alignment of the shielding disk, as it was observed in our experience.…”

“…The two main criticalities in this step of the procedure are the misalignment and the wrong orientation of the disk. 10,11 B-IOERT was introduced in the "Azienda Sanitaria Universitaria Integrata" of Trieste in 2012 using the Mobetron ® (IntraOp Medical, Inc. Santa Clara, CA), a "dedicated" electron beam accelerator, that produces electrons with nominal energies of 6, 9, and 12 MeV at dose rates up to approximately 10 Gy/min (Figure 1). Initially it was used as an anticipated boost in the treatment of early breast cancer and since March 2018 also as APBI in selected patients, according to the international recommendations.…”

Reliability of RT-PCR tests to detect SARS-CoV-2: risk analysis

“…Each cause described is associated with its consequences (local effect followed by final effect) and a criticality calculated from three indices [34], in the following manner:…”

A failure modes and effects analysis quality management framework for image‐guided small animal irradiators: A change in paradigm for radiation biology

“…In this study, we apply the American Association of Physicists in Medicine (AAPM) Task Group 100 (TG-100) Failure Modes and Effects Analysis (FMEA) methodology 22 to apply modern risk-based analysis techniques to IGCSAI, as it has been done for a number of other medical physics applications. [22][23][24][25][26][27][28][29][30][31][32][33][34][35] In the process, we propose a new process map specific to IGCSAI that changes the paradigm from individual errors in radiation delivery, to groups that are highlighted in a proposed new severity table. We also perform a preliminary FMEA survey based on expert opinion from SARRP operators.…”