Integrating machine-readable user interface requirements into open networked operating rooms.

Abstract

Comprehensive risk management (RM) and usability engineering (UE) must be performed to enable safe and usable interoperable medical device systems (according to IEEE 11073 SDC). This has to be fulfilled by applying recognized standards such as ISO 14971 (RM) and IEC 62366-1 (UE). Addressing the complexity of use cases with multiple network participants requires defining use context, hazardous situations, user profiles, user interfaces, system function contributions, limitations, configurations, and required conditions for safe use. We propose extending the categories mentioned in IEEE 11073-10700 with standardized user interface requirements provided by medical device manufacturers. A consumer of networked services can consider those UI Profiles containing design-, risk-, and process-related UI requirements during its design phase, usability engineering process, and risk management. This allows a systematic deficiency analysis prior to device usage, encompassing human-induced risks and thereby enhancing usability, patient safety, and finally operational efficiency. Using benchmarked, verified, and tested UI controls to create user interfaces that fulfill those requirements automatically might also be a solution for the future. This work presents an architectural overview incorporating ISO IEEE 11073-10700 standard requirements. Significantly, it extends these standards by introducing categories that enhance support for the usability engineering and risk management process, emphasizing the role of UI Profiles in achieving safe and usable operating room environments with more flexibility regarding interoperability and enabling a human-induced risk analysis prior to device usage. The number of surveyed manufacturers (8) and the need for real-world validation are limitations of this work, which should be validated by future work.