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      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

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          Abstract

          Introduction

          Failure 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 methods

          A 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.

          Results

          Fifty-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).

          Discussion

          The 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.

          Conclusion

          FMECA 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.

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          Most cited references10

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          Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement.

          Candace R. Correa, Eleanor E R Harris, Maria Leonardi … (2017)
          To update the accelerated partial breast irradiation Consensus Statement published in 2009 and provide guidance on use of intraoperative radiation therapy (IORT) for partial breast irradiation in early-stage breast cancer, based on published evidence complemented by expert opinion.
          Article 0 comments Cited 178 times – based on 0 reviews     Review now
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            Analysis of local and regional recurrences in breast cancer after conservative surgery.

            E Botteri, V Bagnardi, N Rotmensz … (2010)
            A minority of patients treated conservatively for breast cancer will develop local or regional recurrences. Our aim was to determine how their occurrence may be linked to the evolution of the disease. We analyzed 2784 women treated for early-stage breast cancer by quadrantectomy and whole-breast irradiation in a single institution. We evaluated the prognostic factors associated with local, regional and distant recurrences and the prognostic value of local and regional recurrences on systemic progression. After a median follow-up of 72 months, we observed 33 local events, 35 regional events and 222 metastases or deaths as first events (5-year cumulative incidence 1.1%, 1.2% and 7.6%, respectively). Size, estrogen receptor status, Her2/Neu and Ki-67 were associated with all three types of events, while axillary status and vascular invasion were associated only with the occurrence of metastases or death. Young age increased the risk of local recurrence. Local and regional recurrences were associated with an increased risk of systemic progression: hazard ratios 2.5 [95% confidence interval (CI) 1.1-5.8] and 5.3 (95% CI 3.0-9.5), respectively. Local and regional recurrences after breast-conserving surgery are rare events. They are markers of tumor aggressiveness and indicators of an increased likelihood of distant metastases.
            Article 0 comments Cited 39 times – based on 0 reviews     Review now
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              IORT with electrons as boost strategy during breast conserving therapy in limited stage breast cancer: long term results of an ISIORT pooled analysis.

              Gerd Fastner, Felix Sedlmayer, Florian Merz … (2013)
              Linac-based intraoperative radiotherapy with electrons (IOERT) was implemented to prevent local recurrences after breast conserving therapy (BCT) and was delivered as an intraoperative boost to the tumor bed prior to whole breast radiotherapy (WBI). A collaborative analysis has been performed by European ISIORT member institutions for long term evaluation of this strategy.
              Article 0 comments Cited 24 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Journal
                Journal ID (nlm-ta): Front Med (Lausanne)
                Journal ID (iso-abbrev): Front Med (Lausanne)
                Journal ID (publisher-id): Front. Med.
                Title: Frontiers in Medicine
                Publisher: Frontiers Media S.A.
                ISSN (Electronic): 2296-858X
                Publication date (Electronic): 28 August 2017
                Publication date Collection: 2017
                Volume: 4
                Electronic Location Identifier: 138
                Affiliations
                [1] 1Department of Radiation Oncology, Azienda Sanitaria Universitaria Integrata di Trieste (ASUITS) , Trieste, Italy
                [2] 2Department of Medical Physics, Azienda Sanitaria Universitaria Integrata di Trieste (ASUITS) , Trieste, Italy
                [3] 3Department of Surgery, University of Trieste , Trieste, Italy
                [4] 4Department of Physics, University of Trieste , Trieste, Italy
                [5] 5Department of Medical Direction, Azienda Sanitaria Universitaria Integrata di Trieste (ASUITS) , Trieste, Italy
                Author notes

                Edited by: Joachim Paul Hasebrook, Steinbeis University Berlin, Germany

                Reviewed by: Frits Van Merode, Maastricht University Medical Centre, Netherlands; Haitham Mutlak, University Hospital Frankfurt, Germany

                *Correspondence: Marina Bortul, m.bortul@ 123456fmc.units.it

                Specialty section: This article was submitted to Intensive Care Medicine and Anesthesiology, a section of the journal Frontiers in Medicine

                Article
                DOI: 10.3389/fmed.2017.00138
                PMC ID: 5581388
                SO-VID: 8d72ba41-e402-4b12-a1f9-f28559c496a9
                Copyright © Copyright © 2017 Vidali, Severgnini, Urbani, Toscano, Perulli and Bortul.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                Date received : 13 April 2017
                Date accepted : 02 August 2017
                Page count
                Figures: 3, Tables: 3, Equations: 0, References: 14, Pages: 8, Words: 4954
                Categories
                Subject: Medicine
                Subject: Community Case Study

                Keywords: risk assessment,intraoperative electron beam radiotherapy,quality assurance,fmeca,patient safety
                Data availability:
                Keywords: risk assessment, intraoperative electron beam radiotherapy, quality assurance, fmeca, patient safety

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