A practical, structured template for identifying use-related risks, critical tasks, and risk controls throughout medical device development.
Read our practical guide to use-related risk analysis for an overview of how to build and maintain an effective URRA.
Use-related risk analysis can quickly become difficult to manage when tasks, use errors, hazards, harms, risk controls, and supporting evidence are documented across separate files. This template brings those elements together in a structured workbook designed to make your URRA easier to build, review, update, and trace throughout the human factors engineering process.Sources & Guidance
Project and device summary
Task inventory and analysis
Use-related risk analysis worksheet
Critical task identification
Foreseeable use errors and hazardous situations
Potential harms and severity ratings
Risk controls and mitigation strategies
Known use problems and comparative analysis
Links to supporting research and evaluation evidence
Summary and review worksheets
Sources and guidance references
Use-Related Risk Analysis, or URRA, is the process of identifying how interactions between users, a medical device, and its use environment could contribute to hazardous situations and patient or user harm. A URRA typically examines the tasks users must perform, the use errors that could occur, the circumstances that could lead to those errors, their potential consequences, and the measures used to reduce associated risk.
More than a standalone risk document, the URRA can serve as an important link between user research, task analysis, design decisions, formative usability testing, risk management, and human factors validation.
When maintained throughout development, the URRA creates a traceable record of what could go wrong, why it matters, what has been done about it, and how the resulting controls are evaluated.
Read the URRA Guide
A guide for medical device teams and human factors practitioners seeking practical advice for creating and maintaining a URRA. Use the guide to influence design decisions, formative evaluation, critical task identification, and human factors validation.
The template is designed to support both an initial use-related risk analysis and ongoing refinement as the device, interface, and understanding of users evolve. If you’re building a URRA for the first time or want more context on the process our Practical Guide to Use-Related Risk Analysis walks through the key concepts, inputs, and decisions behind the analysis.
Start by documenting the intended users, use environments, and major tasks associated with the device. From there, identify reasonably foreseeable use errors, hazardous situations, and potential harms associated with those tasks.
For each relevant task, the workbook can be used to document:
Task or use step
Potential use error
Hazardous situation
Potential harm
Severity
Contributing factors
Risk control measures
Critical task determination
Supporting research or evaluation evidence
Reviewer comments and findings
The URRA should be treated as a living part of the development process. Findings from contextual research, cognitive task analysis, heuristic reviews, formative usability studies, design changes, and other human factors activities can all inform and refine the analysis over time.
As the program progresses, the URRA can also help establish a clear rationale for which tasks require particular attention during human factors validation.
Completing the spreadsheet is only part of effective use-related risk management. Determining which use errors are reasonably foreseeable, understanding why they may occur, identifying appropriate risk controls, and establishing which tasks require validation all depend on a strong understanding of users, tasks, environments, and device design.
HF Designworks can support teams throughout the medical device human factors process, including user research, task analysis, use-related risk analysis, interface design, formative usability evaluation, and human factors validation.