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.

Solving challenges in inter- and trans-disciplinary working teams: Lessons from the surgical technology field.

INTRODUCTION: Engineering a medical technology is a complex process, therefore it is important to include experts from different scientific fields. This is particularly true for the development of surgical technology, where the relevant scientific fields are surgery (medicine) and engineering (electrical engineering, mechanical engineering, computer science, etc.). Furthermore, the scientific field of human factors is important to ensure that a surgical technology is indeed functional, process-oriented, effective, efficient as well as user- and patient-oriented. Working in such trans- and inter-disciplinary teams can be challenging due to different working cultures. The intention of this paper is to propose an innovative cooperative working culture for the interdisciplinary field of computer-assisted surgery (CAS) based on more than ten years of research on the one hand and the interdisciplinary literature on working cultures and various organizational theories on the other hand. METHODOLOGY: In this paper, a retrospective analysis of more than ten years of research work in inter- and trans-disciplinary teams in the field of CAS will be performed. This analysis is based on the documented observations of the authors, the study reports, protocols, lab reports and published publications. To additionally evaluate the scientific experience in an interdisciplinary research team, a literature analysis regarding scientific literature on trans- and inter-disciplinarity was performed. Own research and literature analyses were compared. RESULTS: Both the literature and the scientific experience in an interdisciplinary research team show that consensus finding is not always easy. It is, however, important to start trans- and interdisciplinary projects with a shared mental model and common goals, which include communication and leadership issues within the project teams, i.e. clear and unambiguous information about the individual responsibilities and objectives to attain. This is made necessary due to differing leadership cultures within the cooperating disciplines. Another research outcome is the relevance of a cooperative learning culture throughout the complete duration of the project. Based on this cooperation, new ideas and projects were developed, i.e. a training concept for surgical trainers including technological competence for surgeons. DISCUSSION: An adapted innovative paradigm for a cooperating working culture in CAS is based on a shared mental model and common goals from the very beginning of a project. CONCLUSIONS: All actors in trans- and inter-disciplinary teams need to be interested in cooperation. This will lead to a common view on patients and technology models.

Development and validation of an artificial wetlab training system for the lumbar discectomy.

PURPOSE: An initial research indicated that realistic haptic simulators with an adapted training concept are needed to enhance the training for spinal surgery. METHODS: A cognitive task analysis (CTA) was performed to define a realistic and helpful scenario-based simulation. Based on the results a simulator for lumbar discectomy was developed. Additionally, a realistic training operating room was built for a pilot. The results were validated. RESULTS: The CTA showed a need for realistic scenario-based training in spine surgery. The developed simulator consists of synthetic bone structures, synthetic soft tissue and an advanced bleeding system. Due to the close interdisciplinary cooperation of surgeons between engineers and psychologists, the iterative multicentre validation showed that the simulator is visually and haptically realistic. The simulator offers integrated sensors for the evaluation of the traction being used and the compression during surgery. The participating surgeons in the pilot workshop rated the simulator and the training concept as very useful for the improvement of their surgical skills. CONCLUSIONS: In the context of the present work a precise definition for the simulator and training concept was developed. The additional implementation of sensors allows the objective evaluation of the surgical training by the trainer. Compared to other training simulators and concepts, the high degree of objectivity strengthens the acceptance of the feedback. The measured data of the nerve root tension and the compression of the dura can be used for intraoperative control and a detailed postoperative evaluation.

Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry.

To reduce the risk of application error, the federal legislator has demanded a development process which is oriented towards usability (DIN EN 62366). Therefore, the research question concerns the application of this standard by medical device manufacturers. Questionnaires were filled out by five trained interviewers in fully standardized face-to-face interviews at MEDICA Düsseldorf 2010. The results are based on 65 interviews. Almost all companies evaluated usability as relevant for product development; however, the understanding of usability through companies can still be improved as well as increasing the amount of trained usability experts in the process.