Applying User Interface Profiles to Ensure Safe Remote Control within the Open Networked Operating Room in accordance with ISO IEEE 11073 SDC

Abstract: The ISO IEEE 11073 SDC Standard family enables manufacturer independent device connectivity and therefore interoperability in the OR and hospital. Supplementary standards like the Devices Specializations (IEEE 11073-107XX) describe how medical devices present themselves in the network and the requirements other network participants must comply with in order to interact in the sense of a plug-and-play approach. However, these device models and requirements do not include information about Human Machine Interaction (HMI) characteristics like visualization, control types or any other user interface related specifications and guidelines, which are necessary to create a safe and usable remote user interface. This will be relevant for central or mobile OR/ICU cockpits/units. Additional device-based UI specifications and rules are necessary for medical device manufacturers and clinical operators to allow safe and usable remote interfaces, and future-proof plug-and-play solutions.The question of liability in the operation of openly networked medical devices is of course an interesting and important aspect for medical device manufacturers. Here, on the one hand, technical interoperability and, on the other hand, safe HMI in the combined use of medical devices must be guaranteed.A systematic approach to create a safe and usable UI in open networked ORs by providing UI requirements to the network participants within a SDC complemental UI standard (e.g., in DevSpecs or KeyPurposes) would greatly facilitate the conformity assessment process for manufacturers, especially for the controlling network participant (SDC service Consumer), who needs to perform a comprehensive usability evaluation and human-induced risk analysis in a new context of use.The Chair of Medical Engineering (mediTEC) at RWTH Aachen University has addressed these issues and has developed a methodological approach to create a specific User Interface Profile for each medical device type and corresponding HMI design rules, considering risk- and process-related requirements for medical device functions and for input and output devices. This approach defines a set of rules, requirements, and specifications regarding Human Machine Interactions a network subscriber must fulfill to display or operate device properties.The User Interface Profile contains among other things: a list of device properties, grouping information, additional applicable standards, user profile, input and output devices that are suitable and/or required from a risk analysis point of view, screen parameters according to DIN 6868-157 and speaker parameters. In addition, for every device property the following properties must be defined: visibility level, elementary task, criticality, and necessary labeling information.These initial implementations have been integrated and validated by a representative user group (neurosurgeons, orthopedic surgeons and ENT surgeons of the University Clinic RWTH Aachen) within a surgical SDC workstation as a part of a surgical SDC demonstrator (Yilmaz et al. 2020). Looking ahead, parts of the User Interface Profiles will be applied and implemented into the ISO IEEE P11073-10721 draft (using the example of high frequency cutting devices) in collaboration with the leading enterprises in Germany.

Keywords: SDC, IEEE 11073, Devices Specialization, User Interface, Usability, Medical User Interface

DOI: 10.54941/ahfe1002094

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