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

Area of Science:

• Medical device systems engineering
• Human-computer interaction
• Patient safety research

Background:

• Interoperable medical device systems require robust risk management (RM) and usability engineering (UE).
• Existing standards like ISO 14971 (RM) and IEC 62366-1 (UE) address safety but can be extended for complex networked environments.
• Defining use context, hazardous situations, and user profiles is essential for safe system design.

Purpose of the Study:

• To propose an extension to IEEE 11073-10700 by introducing standardized User Interface (UI) Profiles.
• To enhance the risk management and usability engineering processes for medical devices.
• To enable systematic deficiency analysis and human-induced risk assessment prior to device deployment.

Main Methods:

• Architectural overview incorporating ISO/IEEE 11073-10700 requirements.
• Development of standardized UI Profiles detailing design, risk, and process-related UI requirements.
• Analysis of how UI Profiles support RM and UE in complex medical device systems.

Main Results:

• The proposed UI Profiles extend current standards, offering enhanced support for RM and UE.
• UI Profiles facilitate a systematic analysis of human-induced risks before device usage.
• The approach aims to improve usability, patient safety, and operational efficiency in networked medical environments.

Conclusions:

• Standardized UI Profiles are a valuable addition to medical device interoperability standards.
• Implementing UI Profiles can proactively address usability and safety concerns, particularly in complex systems.
• Future work should include real-world validation with a larger number of manufacturers.