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

Radiation Oncology

Marie Claire Cantone⁶  Laura Fariselli²  Giancarlo Beltramo¹  Pietro Mancosu³  Tiziana Malatesta⁴  Irene Redaelli¹  Cristina Vite⁷  Maria Luisa Fumagalli⁵  Anna Stefania Martinotti¹  Elena De Martin⁵  Ivan Veronese⁶ 

[1] Centro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy;Fondazione IRCCS Istituto Neurologico Carlo Besta Milano, Unità di Radioterapia, Milan, Italy;Reparto di Radioterapia Oncologica, Istituto Clinico Humanitas, Milan, Italy;Ospedale San Giovanni Calibita Fatebenefratelli, UOC Fisica Sanitaria AFAR, Rome, Italy;Fondazione IRCCS Istituto Neurologico Carlo Besta Milano, UO Direzione Sanitaria, Milan, Italy;Dipartimento di Fisica, Università degli Studi di Milano, Via Celoria 16, Milan 20133, Italy;Present address; Now at: Clinica Luganese, Lugano, Switzerland

关键词: Spine;    Liver;    Tracking;    SBRT, CyberKnife;    FMEA;   

Others  :  1228513
DOI  :  10.1186/s13014-015-0438-0

 received in 2015-01-16, accepted in 2015-06-09,  发布年份 2015

【 摘 要 】

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.

【 授权许可】

   
2015 Veronese et al.

【 图 表 】

Fig. 1.

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