Human-Machine-Interaction and Risk Management


The working group "Human-Machine-Interaction and Risk Management" has emerged from the OR.NET subproject "Approval capability" as well as the OR.NET work package "Human-Machine Interfaces for Open Integrated Medical Devices".

Within the scope of the current work, concepts for the design of central user interface units, e.g. a surgical workstation, have been developed and implemented. The risk analysis and the design of the user interfaces are based on MMI-specific characteristics (User Interface Profiles), which extended the technical device profile. Furthermore, new and innovative input and output devices (e.g. a universal foot switch, a height-adjustable foot board, etc.), which have been adapted to the tasks and wishes of the surgeons and the OR personnel, are currently being developed.

Mission of the working group

The tasks include, among others, the development of concepts for graphical user interfaces for central work stations in the operating theatre, e.g. a surgical workstation, an OR microscope or a mobile tablet for the OR personnel. To this end, the requirements for the central user units are determined and subsequently graphical user interfaces are implemented and evaluated in collaboration with medical experts. The work also includes the development of new and specific interfaces, especially for the open integrated operating theatre (e.g. a universal foot switch, a height-adjustable foot board, etc.).

Goals of the working group

The goal is, inter alia, the development of usable and safe Human-Machine-Interfaces in the open integrated operating room, e.g. individual device views as well as process-specific function group views on a central surgical workstation as well as a mobile tablet for the surgical staff. The bases here are HMI-specific user interface profiles and a corresponding methodology for the UI design of integrated medical systems. The goal is also the automatic comparison of user interface profiles before bringing the system into first service in the OR (for clinical operators). Here, the compliance with the MMI specifications (e.g. requirements for input and output devices) has to be assessed when the medical devices and functions are connected. Furthermore,the working group wants to prove that a presentation and availability of information, adapted to the workflow, can help to simplify intraoperative OP processes. The prototypically implemented Human-Machine-Interfaces are then evaluated by surgeons and OR personnel. In addition, human risk analyses of the user interfaces are carried out, using concrete application scenarios.

Publications

  • A. Janß, S. Plogmann & K. Radermacher: Human-centered risk management for medical devices – new methods and tools. Biomedical Engineering / Biomedizinische Technik, 2016, 61(2), pp. 165–181
  • J. Dell’Anna, A. Janß, H. Clusmann & K. Radermacher: A Configurable Footswitch Unit for the Open Networked Neurosurgical OR – Development, Evaluation and Future Perspectives. i-com, 2016, 15(3), pp. 227-247
  • J. Dell’Anna, A. Janß, E.-M. Zeißig, K. Ganser, K. Radermacher & H. Clusmann: Development of new concepts for safe and usable human-machine-interfaces in the open networked neurosurgical OR. 67. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), 1. Joint Meeting mit der Koreanischen Gesellschaft für Neurochirurgie (KNS), 2016
  • E.-M. Zeißig, A. Janß, J. Dell’Anna-Pudlik, M. Ziefle & K. Radermacher: Development and experimental evaluation of an alarm concept for an integrated surgical workstation. Biomedizinische Technik / Biomedical Engineering, 2016, 61(2), pp. 199–209
  • J. Benzko, L. Krause, A. Janß, B. Marschollek, P. Merz, J. Dell’Anna & K. Radermacher: Modular User Interface Design for Integrated Surgical Workplaces. Biomedizinische Technik, 2015, 61(2), pp. 183-197
  • M. Blaar, A. Janß, J. Dell’Anna, A. Höllig, K. Radermacher & H. Clusmann: Bottlenecks and needs in human-human and human-machine interaction – a view from and into the neurosurgical OR. Biomedizinische Technik, 2015, 61(2), pp. 135-146
  • H. Clusmann, M. Blaar, J. Dell’Anna, A. Janß, A. Höllig & K. Radermacher: A critical view into the neurosurgical OR: bottlenecks and perspectives in human-human and human-machine interaction. Proceedings of The European Association of Neurosurgical Societies – EANS 2015, Annual Meeting “Technical advances in Neurosurgery”, 2015
  • H. Clusmann, A. Janß, J. Dell’Anna & K. Radermacher: Improvement of Human-Machine-Interaction and Workflow in the OR by central surgical workstations in an Open-Network approach. Proceedings of The European Association of Neurosurgical Societies – EANS 2015, Annual Meeting “Technical advances in Neurosurgery”, 2015
  • A. Janß, P. Merz, J. Dell’Anna, M. Strake & K. Radermacher: Application of Medical Device User Interface Profiles for Human-Risk Analysis of Open Integrated OR Systems. Proceedings of the 49th DGBMT Annual Conference, 60(1), 2015, pp. 300
  • K. Radermacher & A. Janß: Usability engineering approach towards secure open networks in the integrated operating room of the future. Proc. IUPESM 2015 WORLD CONGRESS ON MEDICAL PHYSICS & BIOMEDICAL ENGINEERING, 2015, pp. 421
  • J. Benzko, A. Janß, J. Dell’Anna & K. Radermacher: Man-Machine Interfaces in the Operating Room. Proceedings of the 48th DGBMT Annual Conference, 59(1), 2014, pp. 430
  • J. Dell’Anna, A. Janß, M. Blaar, A. Höllig, H. Clusmann & K. Radermacher: Analysis of User-Induced Risks in the Neurosurgical OR. Proceedings of the 5th International Conference on Applied Human Factors and Ergonomics 2014, 2014, pp. 352-358
  • A. Janß, J. Benzko, P. Merz, J. Dell’Anna, M. Strake & K. Radermacher: Development of Medical Device UI-Profiles for Reliable and Safe Human-Machine-Interaction in the Integrated Operating Room of the Future. Proceedings of the 5th International Conference on Applied Human Factors and Ergonomics 2014, 2014, pp. 1855-1860
  • A. Janß & K. Radermacher: Usability First – Modellbasierter Ansatz zur nutzungsorientierten Risikoanalyse von Medizinprodukten. Bundesgesundheitsblatt – Gesundheitsforschung – Gesundheitsschutz. Themenschwerpunkt: Sicherheit von Medizinprodukten – Neueste Entwicklungen, 2014, 57(12), pp. 1384-1392

The next public presentation of the results will take place at the conhIT2017 between the 25th and 27th of April in Berlin. The group “Human-Machine-Interaction and Risk Management” is working intensively within the framework of the EFRE project ZiMT (Certified Integrated Medical Technology, Duration: 01.07.2016-30.06.2019).

Figure 1: GUI Framework of a surgical workstation
Figure 2: Universal-Footswitch for ENT, orthopaedics and neuro-surgery
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