Safety and Performance of Enteral Device Connectors to Reduce Misconnection Risks
This guidance applies to connectors used in enteral devices intended for administration of fluids and nutritional substances, regulated under 21 CFR 876.5980. This includes enteral feeding tubes, transition connectors, gastrostomy tubes, gastrointestinal tubes, gastrojejunal tubes, nasogastric tubes, nasoduodenal tubes, as well as extension/administration sets and feeding reservoirs/spikes/syringes. It also covers side ports and adapter connections but excludes balloon inflation ports.
What You Need to Know? 👇
What are the key safety requirements for enteral connectors to prevent misconnections?
Enteral connectors must conform to AAMI/CN3:2014 (PS) Part 3 standards, be made of rigid/semi-rigid materials with modulus >700 MPa, and undergo mechanical testing to demonstrate non-interconnectability with non-enteral devices like IV lines.
Why are color-coding and labeling alone insufficient for enteral connector safety?
Color-coding and labeling by themselves cannot adequately mitigate misconnection risks, especially with similarly colored IV PICC lines. Physical incompatibility through proper connector design is required to prevent dangerous misconnections that have caused patient deaths.
What testing is required for proprietary enteral connectors that don’t meet AAMI standards?
Proprietary connectors must undergo mechanical force testing per AAMI/ANSI/ISO 80369-1 against representative market samples of non-enteral connectors, plus risk assessment, usability testing, and full test reports in 510(k) submissions.
How should manufacturers handle side ports on enteral feeding tubes?
Side ports for flushing/medication should be tested like main enteral connectors using rigid materials and mechanical testing. Balloon inflation ports have different risk profiles but still require risk identification and mitigation strategies.
What labeling recommendations does FDA provide for enteral devices?
Avoid terms like “enteral-only” and “Non-IV.” Use clear statements like “The device connection is intended to connect to [compatible devices]” and specify tested applications that demonstrate reduced misconnection likelihood.
When is a new 510(k) submission required for enteral connector modifications?
If modifications to conform to AAMI/CN3:2014 Part 3 would normally trigger a new 510(k), FDA accepts a declaration of conformity in an “add-to-file.” However, proprietary/transition connectors require full 510(k) submissions.
What You Need to Do 👇
Recommended Actions
- Design and test enteral connectors according to AAMI/CN3:2014 (PS)
- Conduct material testing to ensure compliance with rigidity requirements
- Perform mechanical testing to demonstrate non-interconnectability
- Complete comprehensive risk assessment
- Develop appropriate labeling that avoids misleading terms
- Conduct human factors testing for proprietary connectors
- Document all testing and validation in 510(k) submissions
- Consider transition strategy if needed for existing devices
- Implement quality control measures for connector compatibility
- Monitor and report any misconnection incidents
Key Considerations
Non-clinical testing
- Mechanical force testing following AAMI/ANSI/ISO 80369-1 or equivalent to demonstrate non-interconnectability with other healthcare connectors
- Testing against common connectors from intravascular, hypodermic, breathing, urinary, limb cuff inflation and neuraxial devices
- Connectors should not provide secure connection when assembled with moderate force and should easily disengage
Human Factors
- Usability and human factors testing required for proprietary connectors claiming non-interconnectability
- Testing should confirm no unacceptable risks
- Follow AAMI/ANSI HE75 standard
Labelling
- Simplified labeling strategy for easy interpretation
- Avoid terms like “enteral-only” and “Non-IV”
- Include specific compatible devices
- Include warnings about potential misconnections
- Can include color-coding and imprinting as additional features
Safety
- Connectors must be made of rigid or semi-rigid materials with modulus of elasticity >700 MPa
- Risk assessment required to demonstrate misconnection risks are effectively mitigated
- Color-coding and labeling alone are not sufficient safety measures
Other considerations
- Side ports for flushing/drug administration need similar testing as main connectors
- Transition connectors may be temporarily necessary within GI applications
- Syringes for enteral feeding should only attach to enteral connectors
Relevant Guidances đź”—
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Design Considerations for Medical Devices Intended for Home Use
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
Related references and norms đź“‚
- AAMI/CN3:2014 (PS): Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
- AAMI/CN20:2014 (PS): Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods
- AAMI/ANSI/ISO 80369-1: Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
- ASTM D747: Standard Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
- ASTM D790: Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
- AAMI/ANSI HE75: Human Factors Engineering – Design of medical devices