home / skills / a5c-ai / babysitter / use-related-risk-analyzer
This skill helps identify and mitigate use-related hazards in medical devices by applying IEC 62366-1 usability analysis to tasks, interfaces, and training.
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---
name: use-related-risk-analyzer
description: Use-related risk analysis skill for identifying hazards associated with user interaction per IEC 62366-1
allowed-tools:
- Read
- Write
- Glob
- Grep
- Edit
- Bash
metadata:
specialization: biomedical-engineering
domain: science
category: Risk Management
skill-id: BME-SK-009
---
# 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
```yaml
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
This skill performs use-related risk analysis to identify hazards tied to user interaction with medical devices, following IEC 62366-1 usability engineering principles. It produces task decompositions, catalogs use errors, and recommends design or training mitigations to reduce user-caused risks. The outputs are aimed to integrate with ISO 14971 risk management and verification planning.
The skill inspects defined user profiles, use environments, and documented use scenarios to decompose tasks and identify critical tasks. It classifies potential use errors into perception, cognition, and action categories, searches known-problem databases, and generates mitigation options prioritized toward design fixes. It also produces artifacts for usability testing, IFU evaluation, and traces into risk management.
What inputs are required to run an effective analysis?
User profiles, detailed intended use and use scenarios, and characterized use environments are required to produce reliable task analyses and risk recommendations.
Does the skill replace ISO 14971 risk management?
No. It complements ISO 14971 by focusing on use-related hazards and providing artifacts and mitigations that should be integrated into the overall risk management process.