Simulation-based detection of usability conflicts for an ISO/IEEE 11073 SDC workstation: a spine surgery case study

International Journal of Computer Assisted Radiology and Surgery

Abstract

PURPOSE: Open, vendor-independent networking of medical devices via ISO/IEEE 11073 Service-oriented Device Connectivity (SDC) enables central operating room (OR) workstations. Pure interoperability, however, does not guarantee usability or safety, especially when many devices, roles, and workflow phases interact in a dynamic and unpredictable manner [1]. We present a simulation framework that detects resource, workflow, and usability conflicts in SDC-based workstation setups, demonstrating its application to the procedure of dorsal decompression and spinal fusion. METHODS: The framework combines three inputs: (1) a Business Process Model and Notation (BPMN) workflow of cervical decompression/fusion created together with surgeons, (2) device-specific User Interface (UI) Profiles that encode human-machine interaction requirements, and (3) a structured description of the available OR setup (screens, foot- and handswitches, roles, sterility zones). An assignment engine automatically allocates device functions to input/output resources and validates every assignment against a library of constraints. Detected violations (e.g., capacity, temporal relations, sterility zone, feedback conflicts) are reported, and a conflict-free configuration prototype cockpit interface is developed and evaluated by 11 clinicians. RESULTS: Several types of conflict patterns could be detected through simulation, including input device shortages (pedal mismatches), output device limitations (inability to adequately display parameters), or role capacity overload (one person performs too many tasks). Adjusting the OR setup step by step resolved the existing usability violations, yielding a conflict-free assignment. A formative evaluation with 11 clinicians provided initial feedback indicating that the simulation-derived, conflict-free workstation layout is feasible and usable for the selected tasks in the studied procedure. CONCLUSION: The simulation cannot guarantee perfect usability or conflict-free operation. Its reliability ultimately depends on the fidelity of the BPMN workflow, the correctness and completeness of the encoded usability constraints, and the quality of the available UI Profiles. It nevertheless proves to be an efficient early-stage filter. Our results demonstrate that simulation-based conflict detection can reveal usability and safety issues in SDC OR setups prior to their installation.

Authors 6

1. Okan Yılmaz corresponding Aachen Chair of Medical Engineering

   RWTH Aachen University

   Affiliation as printed

   Chair of Medical Engineering, RWTH Aachen University, 52074, Aachen, Germany. yilmaz@hia.rwth-aachen.de

2. Simon Kißmann Aachen Chair of Medical Engineering

   RWTH Aachen University

   Affiliation as printed

   Chair of Medical Engineering, RWTH Aachen University, 52074, Aachen, Germany

3. Rastislav Pjontek Aachen Department of Neurosurgery

   Universitätsklinikum Aachen

   Affiliation as printed

   Department of Neurosurgery, University Hospital Aachen, 52074, Aachen, Germany

4. Christian Blume Aachen Department of Neurosurgery

   Universitätsklinikum Aachen

   Affiliation as printed

   Department of Neurosurgery, University Hospital Aachen, 52074, Aachen, Germany

5. Klaus Radermacher Aachen Chair of Medical Engineering

   RWTH Aachen University

   Affiliation as printed

   Chair of Medical Engineering, RWTH Aachen University, 52074, Aachen, Germany

6. Armin Janß Aachen Chair of Medical Engineering

   RWTH Aachen University

   Affiliation as printed

   Chair of Medical Engineering, RWTH Aachen University, 52074, Aachen, Germany