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.