Design Considerations for Medical Devices Intended for Home Use
This guidance assists manufacturers in designing and developing home use devices that comply with safety, effectiveness, and regulatory requirements. It applies to both prescription and over-the-counter medical devices (Class I, II, or III) intended for use in any environment outside professional healthcare facilities.
Recommended Actions
- Develop comprehensive risk management plan addressing home use environment
- Conduct thorough human factors and usability testing
- Design device considering environmental factors and user capabilities
- Implement appropriate safety features and alarm systems
- Create clear, simple labeling and instructions
- Establish customer support and adverse event reporting systems
- Validate device performance in simulated home environments
- Consider training requirements and develop training programs
- Plan for emergency scenarios and backup systems
- Ensure compliance with relevant standards and regulations
Key Considerations
Non-clinical testing
- Test device operation in anticipated temperature ranges
- Test device operation within range of atmospheric pressures
- Test mechanical strength for impact, dropping, rough handling
- Test device operation with varying humidity levels
- Test fluid exposure tolerance
Human Factors
- Consider users’ physical capabilities (size, mobility, dexterity, strength)
- Consider users’ sensory/perceptual abilities (vision, hearing)
- Consider users’ cognitive abilities and literacy levels
- Consider users’ emotional state
- Conduct usability testing under simulated use conditions
- Validate effectiveness of user training programs
Software
- Develop architecture and algorithms for performance, error detection and recovery
- Consider how software upgrades will be performed in home environment
- Validate software according to its level of concern
Cybersecurity
- Address wireless technology security if applicable
- Consider RF wireless coexistence with other devices
- Ensure data integrity for wireless communications
Labeling
- Provide simple, concise, easily understood instructions
- Include clear warnings of hazards
- Provide emergency procedures
- Include proper disposal instructions
- Include cleaning/maintenance instructions
- Provide information about storage requirements
Safety
- Design lockout mechanisms when needed
- Include backup power options for electrical devices
- Ensure EMC compatibility in home environment
- Design appropriate alarm systems
- Consider emergency use scenarios
Other considerations
- Consider environmental factors (location, contaminants, water supply)
- Address maintenance and calibration requirements
- Consider international use requirements
- Provide customer service support
- Implement medical device reporting procedures
Relevant Guidances
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- ANSI/AAMI/ISO14971:2007/(R)2010: Medical devices - Application of risk management to medical devices
- IEC 62304:2006: Medical device software - Software life cycle processes
- ANSI/AAMI ES60601-1:2012: Medical electrical equipment - General requirements for basic safety
- ANSI/AAMI/IEC 60601-1-2:2014: EMC requirements and tests
- ANSI/AAMI HE75:2009: Human factors engineering - Design of medical devices
- ANSI/AAMI/IEC 62366:2007/(R)2013: Medical devices - Application of usability engineering
Original guidance
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