Use-Related Risk Analyzer Skill

Purpose

The Use-Related Risk Analyzer Skill identifies and evaluates hazards associated with user interaction with medical devices, implementing IEC 62366-1 usability engineering methodology and supporting human factors risk analysis.

Capabilities

• Use scenario identification
• Task analysis decomposition
• Use error categorization (perception, cognition, action)
• Known use problems database search
• Risk mitigation strategy development
• Training vs. design solution recommendations
• User interface risk analysis
• Critical task identification
• Use error root cause analysis
• Usability test planning support
• IFU effectiveness evaluation

Usage Guidelines

When to Use

• Conducting use-related risk analysis
• Planning usability engineering activities
• Designing user interfaces
• Evaluating training effectiveness

Prerequisites

• User profiles defined
• Use environments characterized
• Intended use documented
• Use scenarios identified

Best Practices

• Integrate with ISO 14971 risk management
• Prioritize inherently safe design
• Test with representative users
• Validate critical tasks

Process Integration

This skill integrates with the following processes:

• Human Factors Engineering and Usability
• Medical Device Risk Management (ISO 14971)
• Verification and Validation Test Planning
• Design Control Process Implementation

Dependencies

• IEC 62366-1 standard
• FDA Human Factors guidance
• AAMI HE75 guidelines
• Known problems databases
• User interface standards

Configuration

use-related-risk-analyzer:
  user-profiles:
    - healthcare-professional
    - patient
    - caregiver
    - lay-user
  error-categories:
    - perception-error
    - cognition-error
    - action-error
  use-environments:
    - clinical
    - home
    - emergency

Output Artifacts

• Use-related risk analysis documents
• Task analysis worksheets
• Use error catalogs
• Critical task lists
• Mitigation recommendations
• Usability test specifications
• Training requirements
• IFU content recommendations

Quality Criteria

• All user groups and scenarios analyzed
• Use errors systematically identified
• Critical tasks properly validated
• Mitigation strategies prioritize safe design
• Training addresses residual use risks
• Analysis integrates with ISO 14971