Sharps Injury Prevention Features in Medical Devices: Testing and Documentation Requirements
This guidance document is focused on medical devices that contain a sharps injury prevention feature, which is designed with a component or attachment (either active or passive) that protects users from sharps injuries. The guidance specifically excludes sharps containers and needle recapping devices.
Recommended Actions
- Conduct comprehensive risk analysis before submission
- Perform complete bench testing program including:
- Material strength testing
- Activation/deactivation forces
- Fluid flow and accuracy testing
- Microbial ingress testing (if applicable)
- Execute simulated clinical use testing with:
- Appropriate sample size (recommended 500 devices)
- Multiple healthcare professional evaluators
- Documented training protocol
- Complete data collection forms
- Prepare detailed device documentation including:
- Complete material composition
- Physical specifications
- Mechanical specifications
- Design features comparison to predicates
- Develop comprehensive labeling including:
- Clear instructions for use
- Safety warnings
- Training materials
- Compatibility information
- Ensure compliance with:
- Design controls
- Sterilization requirements
- Biocompatibility testing
- Applicable standards
- Submit 510(k) with complete documentation of all testing and evaluations
Key Considerations
Clinical testing
- Simulated clinical use testing required with healthcare professionals
- Study design should include sufficient evaluators and sample size
- Testing should simulate critical clinical variables
- Report forms should capture detailed user feedback
- Failed tests must be reported and explained
Non-clinical testing
- Bench testing under dry and wet conditions
- Testing should assess forces, activations, puncture resistance, fluid flow, accuracy
- Material strength testing (tensile, flexural, elongation)
- Microbial ingress testing for needleless devices
Human Factors
- User should easily identify when safety feature is activated
- Single-handed technique should be possible
- Safety feature should remain protective through disposal
- Color coding should follow user conventions
- Training needs should be evaluated
Labeling
- Clear intended use statement
- Detailed directions for use with illustrations
- Instructions for activation/deactivation
- Precautions related to hand size/dexterity
- Warnings about fluid leakage
- Device description and compatibility information
Biocompatibility
- Testing according to ISO 10993-1
- Selection of appropriate tests based on duration and contact
- Documentation of pass/fail criteria
Safety
- Device must maintain sterility (SAL of 1x10-6)
- Safety feature must not be deactivatable once activated
- Shields must fully enclose sharp and prevent finger access
Other considerations
- Design controls per 21 CFR 820.30
- Risk analysis required
- Material composition details needed
- Physical and mechanical specifications required
Relevant Guidances
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Design Controls for Medical Device Manufacturers
Related references and norms
- ISO 594: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Equipment
- ANSI/AAMI HE48-1993: Human factors engineering guidelines and preferred practices for the design of medical devices
- ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
Original guidance
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