Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to CyberKnife Stereotactic Body Radiation Therapy (SBRT)

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

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Background: A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to assess the risks for patients undergoing Stereotactic Body Radiation Therapy (SBRT) treatments for lesions located in spine and liver in two CyberKnife® Centres. Methods: The various sub-processes characterizing the SBRT treatment were identified to generate the process trees of both the treatment planning and delivery phases. This analysis drove to the identification and subsequent scoring of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system. Novel solutions aimed to increase patient safety were accordingly considered. Results: The process-tree characterising the SBRT treatment planning stage was composed with a total of 48 sub-processes. Similarly, 42 sub-processes were identified in the stage of delivery to liver tumours and 30 in the stage of delivery to spine lesions. All the sub-processes were judged to be potentially prone to one or more failure modes. Nineteen failures (i.e. 5 in treatment planning stage, 5 in the delivery to liver lesions and 9 in the delivery to spine lesions) were considered of high concern in view of the high RPN and/or severity index value. Conclusions: The analysis of the potential failures, their causes and effects allowed to improve the safety strategies already adopted in the clinical practice with additional measures for optimizing quality management workflow and increasing patient safety.

Original languageEnglish
Article number132
JournalRadiation Oncology
Volume10
Issue number1
DOIs
Publication statusPublished - Jun 13 2015

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Radiotherapy
Spine
Patient Safety
Liver
Therapeutics
Workflow
Healthcare Failure Mode and Effect Analysis
Safety
Neoplasms

Keywords

  • CyberKnife
  • FMEA
  • Liver
  • SBRT
  • Spine
  • Tracking

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging

Cite this

Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to CyberKnife Stereotactic Body Radiation Therapy (SBRT). / Veronese, Ivan; De Martin, Elena; Martinotti, Anna Stefania; Fumagalli, Maria Luisa; Vite, Cristina; Redaelli, Irene; Malatesta, Tiziana; Mancosu, Pietro; Beltramo, Giancarlo; Fariselli, Laura; Cantone, Marie Claire.

In: Radiation Oncology, Vol. 10, No. 1, 132, 13.06.2015.

Research output: Contribution to journalArticle

Veronese, Ivan ; De Martin, Elena ; Martinotti, Anna Stefania ; Fumagalli, Maria Luisa ; Vite, Cristina ; Redaelli, Irene ; Malatesta, Tiziana ; Mancosu, Pietro ; Beltramo, Giancarlo ; Fariselli, Laura ; Cantone, Marie Claire. / Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to CyberKnife Stereotactic Body Radiation Therapy (SBRT). In: Radiation Oncology. 2015 ; Vol. 10, No. 1.
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