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.

Ontology for assessment studies of human-computer-interaction in surgery.

OBJECTIVE: New technologies improve modern medicine, but may result in unwanted consequences. Some occur due to inadequate human-computer-interactions (HCI). To assess these consequences, an investigation model was developed to facilitate the planning, implementation and documentation of studies for HCI in surgery. METHODS AND MATERIAL: The investigation model was formalized in Unified Modeling Language and implemented as an ontology. Four different top-level ontologies were compared: Object-Centered High-level Reference, Basic Formal Ontology, General Formal Ontology (GFO) and Descriptive Ontology for Linguistic and Cognitive Engineering, according to the three major requirements of the investigation model: the domain-specific view, the experimental scenario and the representation of fundamental relations. Furthermore, this article emphasizes the distinction of "information model" and "model of meaning" and shows the advantages of implementing the model in an ontology rather than in a database. RESULTS: The results of the comparison show that GFO fits the defined requirements adequately: the domain-specific view and the fundamental relations can be implemented directly, only the representation of the experimental scenario requires minor extensions. The other candidates require wide-ranging extensions, concerning at least one of the major implementation requirements. Therefore, the GFO was selected to realize an appropriate implementation of the developed investigation model. The ensuing development considered the concrete implementation of further model aspects and entities: sub-domains, space and time, processes, properties, relations and functions. CONCLUSIONS: The investigation model and its ontological implementation provide a modular guideline for study planning, implementation and documentation within the area of HCI research in surgery. This guideline helps to navigate through the whole study process in the form of a kind of standard or good clinical practice, based on the involved foundational frameworks. Furthermore, it allows to acquire the structured description of the applied assessment methods within a certain surgical domain and to consider this information for own study design or to perform a comparison of different studies. The investigation model and the corresponding ontology can be used further to create new knowledge bases of HCI assessment in surgery.