Development of Medical Device UI-Profiles for Reliable and Safe Human-Machine-Interaction in the Integrated Operating Room of the Future

Abstract: Nowadays, the number of technical systems in the operating room increases constantly. This ongoing spread of technology has significant impacts on the individual working process steps of the surgical team. Besides improving the therapeutic quality, these changes may also lead to new human-induced risks for patients, therapists and third parties. In particular, within intra-operative activities, which depend on a safe and fast operation, surgeons and nurses rely on sophisticated and efficient solutions in terms of Human-Machine-Interfaces in order to perform their tasks reliably and assuredly. Therefore, proprietary integrated workstations with a central usage cockpit have been provided for the operating theatre in recent years. At the Chair of Medical Engineering, a surgical integrated workstation with open interfaces for the integration of various medical devices from different manufacturers is currently been developed in the context of the BMBF (Federal Ministry of Education and Research) funded project OR.NET. For this purpose a suitable central user interface (e.g. multi-function foot switch, touch screen, diagnostic monitor, etc.) will be implemented, in a way that the functions of the various (networked) devices can be offered to the user by a central user interface. The design of the Human-Machine-Interface therefore depends on the available input and output devices, the interaction elements of the graphical user interface, the available medical technical equipment, as well as the medical intervention and the particular process steps and the environmental conditions within the operating room. In this work, a concept for the development of a Medical Device User Interface Profile (UIP) will be presented, using the characterization of process-dependent medical device functions for the modular design of a central user interface in the integrated operating room of the future. The use of standardized UI Profiles should allow the manufacturers to integrate their medical devices, respectively the provided functions in the OR.NET network, without disclosing the risk analysis and related confidential know-how or proprietary information. The UI Profiles will allow both, an automated optimized selection and composition of various user interfaces, and implicitly an optimal design of a central GUI with respect to the criteria of usability and an integrated human risk analysis in terms of Human-Machine Interaction. Specific operation process steps within a neurosurgical workflow will be the framework for the validation process of the UI Profiles. Till now, the UIP concept has been tested within the integration of an ultrasound dissector and an OR microscope.

Keywords: Human-Machine-Interaction, Human Factors, Risk Analysis, Integrated Operating Room, Dynamic and Open Surgical Network, User Interface Profile

DOI: 10.54941/ahfe100507

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