Usability and Safety of a National Automated Urine Output Monitoring Device: Mixed-Methods Evaluation Across Simulated and Clinical Settings

Automated urine output monitoring is a promising strategy to optimize clinical management in intensive care units (ICUs), offering improved accuracy, traceability, and reduced manual errors. This study aimed to evaluate the safety, effectiveness, and usability of automated urine measurement devices through a systematic review and the analysis of a novel domestically developed device tailored to the Brazilian hospital context. The systematic review was registered in PROSPERO (registration number to be included) and followed PRISMA guidelines. A total of 553 studies were identified across databases such as PubMed, Cochrane, Scopus, and LILACS, with 15 meeting inclusion criteria. Results indicate that automated devices outperform traditional methods in measurement accuracy and reduce healthcare workers’ exposure to biological materials. However, barriers such as calibration requirements, clinical integration challenges, and lack of formal usability testing still hinder widespread adoption. Complementarily, the usability of the national urine output monitor was assessed through formative testing, summative evaluation, and a clinical trial. The device met international performance standards, with a satisfactory System Usability Scale (SUS) score and positive user feedback. Nonetheless, critical areas for improvement were identified, particularly regarding interface design and visual feedback. These findings underscore the role of usability assessment in the certification of medical devices and position the national urine output monitor as a viable, adaptable solution for the Brazilian healthcare system.