Applying Human Factors Engineering and Usability Engineering to Medical Devices
This guidance assists medical device manufacturers in applying Human Factors Engineering (HFE) and Usability Engineering (UE) principles during device development to optimize safety and effectiveness for intended users. It focuses on minimizing use errors and resulting harm through proper design of the device user interface, including all points of interaction between users and the device.
Recommended Actions
- Establish HFE/UE processes as part of design controls and risk management
- Conduct preliminary analyses to identify:
- Critical tasks and use scenarios
- User characteristics and capabilities
- Use environment conditions
- Known use problems with similar devices
- Implement iterative design and testing:
- Conduct formative evaluations during development
- Apply risk control measures
- Validate design changes
- Perform human factors validation testing:
- Use representative users and use conditions
- Test all critical tasks
- Document results and analysis
- Address any remaining use-related risks
- Prepare HFE/UE documentation:
- Document processes and results
- Include in design history file
- Submit report in premarket submissions when required
- Monitor post-market performance and address any emerging use-related issues
Key Considerations
Non-clinical testing
- Conduct simulated-use human factors validation testing with minimum 15 participants per distinct user group
- Test environment should be sufficiently realistic to represent actual conditions of use
- Test participants should represent intended users
- All critical tasks should be performed during testing
- Device user interface should represent final design
Human Factors
- Identify and analyze critical tasks that could lead to serious harm if performed incorrectly
- Consider user characteristics, capabilities and limitations
- Evaluate use environment conditions that could affect device use
- Apply risk management strategies to eliminate or reduce use-related hazards
- Document HFE/UE processes and results
Labeling
- Ensure labeling is clear and understandable for intended users
- Include warnings and instructions for critical tasks
- Validate labeling effectiveness during human factors testing
- Consider labeling as part of overall user interface design
Software
- Evaluate software user interface design
- Consider software-driven controls and displays
- Assess information organization and navigation logic
- Test software interface during human factors validation
Safety
- Identify and analyze use-related hazards and risks
- Implement risk control measures
- Validate effectiveness of safety measures
- Document residual risks and rationale for acceptance
Other considerations
- Consider training requirements and validate training effectiveness
- Evaluate device modifications and their impact on usability
- Document HFE/UE processes in design history file
- Submit HFE/UE report in premarket submissions when required
Relevant Guidances
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- List of Device Types That Require Human Factors Data in Premarket Submissions (Draft)
- Design Considerations for Medical Devices Intended for Home Use
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Content of Premarket Submissions for Device Software Functions
- Design Considerations and Recommendations for Interoperable Medical Devices
Related references and norms
- AAMI/ANSI HE75: Human Factors Engineering – Design of Medical Devices
- ANSI/AAMI/IEC 62366: Medical devices – Application of usability engineering to medical devices
- ANSI/AAMI/ISO 14971: Medical Devices – Application of risk management to medical devices
- IEC 60601-1-6: Medical electrical equipment – General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-8: Medical electrical equipment — General requirements for alarm systems
- IEC 60601-1-11: Requirements for medical electrical equipment used in home healthcare environment
Original guidance
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- HTML / PDF
- Issue date: 2016-02-03
- Last changed date: 2019-02-09
- Status: FINAL
- Official FDA topics: Physical Medicine, Errors, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Clinical Chemistry & Clinical Toxicology, Orthopedic, Nose & Throat, Hematology & Pathology, Gastroenterology-Urology, 510(k), Premarket, Ear, Immunology & Microbiology, Radiology, Safety - Issues, Ophthalmic, Medical Devices, Obstetrical & Gynecological, Cardiovascular, Labeling, General Hospital & Personal Use, Molecular and Clinical Genetics, Digital Health, Postmarket, General & Plastic Surgery, Premarket Approval (PMA), Anesthesiology, and Problems, Dental, Neurological
- ReguVirta summary file ID: 642ee2c03298e21339a6dfc8e5f2a206
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