Approaches towards training in human risk management of surgical technology.

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.