Medical Devices with Sharps Injury Prevention Features - Testing, Documentation and Labeling Requirements
This guidance addresses medical devices that contain a sharps injury prevention feature, which is designed with a component or attachment (either active or passive) that protects the user from sharps injuries. The guidance excludes sharps containers and needle recapping devices.
What You Need to Know? 👇
What are the key design requirements for medical devices with sharps injury prevention features?
Devices must allow users to easily identify activation status, remain permanently protective once activated, and enable single-handed activation with hands behind the sharp. Shields must completely enclose needles, retractable sharps must be fully housed, and fixed recessed needles require complete coverage.
What testing is required for sharps injury prevention devices in 510(k) submissions?
Testing includes bench testing under dry and wet conditions, microbial ingress testing for needleless systems, simulated clinical use studies with healthcare professionals, sterilization validation, and biocompatibility assessment. All testing should compare performance against legally marketed predicate devices.
How many devices should be tested in simulated clinical use studies?
FDA recommends testing 500 devices to achieve statistical confidence in performance. This sample size enables detection of grossly defective devices at a 1% level with zero failures expected. Alternative sample sizes require adequate scientific rationale for consideration.
What labeling requirements apply to sharps injury prevention devices?
Labeling must include intended use for injury prevention, positioning instructions for safe operation, aseptic technique guidance, activation/deactivation procedures, disposal instructions, and compatibility information for accessories. Visual aids like illustrations and posters are recommended to clarify directions.
Can manufacturers submit an Abbreviated 510(k) for sharps injury prevention features?
Yes, manufacturers can submit Abbreviated 510(k)s when following this guidance document. The submission must cite this guidance, include a summary report describing device development and testing methods, and demonstrate how identified risks were addressed through design and testing.
What biocompatibility testing is needed for devices with sharps injury prevention features?
Biocompatibility testing should follow ISO-10993 standards, selecting tests appropriate for contact duration and level. If identical materials and processing are used in a predicate device with same contact type, manufacturers may reference the predicate instead of conducting new testing.
What You Need to Do 👇
Recommended Actions
- Implement design controls process according to 21 CFR 820.30
- Conduct comprehensive device testing:
- Bench testing under dry/wet conditions
- Microbial ingress testing if applicable
- Simulated clinical use testing with 500 devices
- Biocompatibility testing
- Prepare detailed device documentation:
- Complete material composition
- Physical and mechanical specifications
- Design features comparison to predicates
- Develop comprehensive labeling including:
- Clear instructions for use
- Safety warnings
- Device description
- Compatibility information for accessories
- Validate sterilization process to achieve SAL 10^-6
- Conduct risk analysis and document risk mitigation measures
- Prepare 510(k) submission incorporating all testing data and documentation
Key Considerations
Non-clinical testing
- Bench testing under dry and wet conditions comparing to similar legally marketed devices
- Testing should assess forces, activations, puncture resistance, fluid flow, accuracy, strength of materials and components
- Microbial ingress testing for needleless devices
- Simulated clinical use testing with healthcare professionals as evaluators
- Statistical considerations for sample size in simulated testing (recommended 500 devices)
Human Factors
- User should easily tell if safety feature is activated
- Once activated, feature cannot be deactivated
- Single-handed technique activation possible
- Shields should completely enclose needle and prevent finger access
- Color usage should have specific purpose and conform to user conventions
Labeling
- Clear identification of intended use for sharps injury prevention
- Detailed directions for safe operation and hand positioning
- Instructions for activation/deactivation and disposal
- Special limitations related to hand size/dexterity
- Warnings about fluid leakage
- Device description including sterility information
- For accessories: compatibility information and connection instructions
Biocompatibility
- Testing according to ISO 10993-1 based on duration and level of contact
- Documentation of pass/fail criteria
- Alternative: identification of predicate device with identical materials/processing
Safety
- Device malfunction prevention through bench testing
- Infection prevention through microbial testing and sterilization
- Sterilization validation to SAL 10^-6
Other considerations
- Design controls under 21 CFR 820.30
- Material composition details including any metallic components
- Physical and mechanical specifications
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Design Controls for Medical Device Manufacturers
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms 📂
- ISO 594: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Equipment
- ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
- ANSI/AAMI HE48-1993: Human factors engineering guidelines and preferred practices for the design of medical devices