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Licensed Unlicensed Requires Authentication Published by De Gruyter April 20, 2016

Approaches towards training in human risk management of surgical technology

  • Norman Geissler ORCID logo , Andrej Machno , Luisa F. Sánchez-Peralta , José Blas Pagador , Francisco M. Sánchez-Margallo and Werner Korb EMAIL logo

Abstract

A safe application of modern surgical technology and computer-assisted surgery devices is based on an operation by adequately trained surgeons who are familiar with the benefits and limitations of the devices. We analyzed the in-depth interviews with seven Spanish and 10 German surgeons. Together with other studies, this analysis highlights the need for specific training in technological competence for surgeons. One way to train technological competence is to help surgeons understanding the basic principles of medical devices as well as explaining the basic concepts of risk analysis and risk management. Based on this premise, a stage model for risk assessment was developed and adapted for the training of surgeons. This was developed further into a train the trainer (TTT) concept, which was then evaluated for two example cases. During TTT-training, the trainers (expert surgeons) performed a risk analysis for several medical devices. Afterwards, the trainers organized a surgical workshop for surgical trainees (resident surgeons), in which high-fidelity simulators and the original medical devices were used. The results showed that the surgeons performed the risk analysis correctly with the stage model and afterwards were able to successfully apply the results in the workshop context.

Acknowledgments

Thanks to the Leipziger Stiftung für Innovation und Technologietransfer, the Saxonian Ministry of Science and Art (SMWK) and the European Social Fonds (ESF) for funding the project. We would also like to thank Zeiss (Oberkochen, Germany) for their support with the operation microscopes used in the Spanish course, and Karl Storz (Tuttlingen, Germany) for their support with the surgical instruments for the FESS and spinal surgery as well as surgical navigation systems used in the German courses. Finally, we thank the Centro de Cirugía de Minima Invasión (CCMIJU) and our clinical partners Prof. Josten, Dr. Vega, Dr. Cenjor and Prof. Strauß.

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Received: 2014-8-1
Accepted: 2016-3-16
Published Online: 2016-4-20
Published in Print: 2016-4-1

©2016 by De Gruyter

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