Special Controls for Implanted Blood Access Devices for Hemodialysis

Recommended Actions

1. Determine device category and applicable special controls
2. Conduct required performance testing based on device type
3. Perform biocompatibility testing according to ISO 10993
4. Validate sterility and establish shelf-life
5. Prepare comprehensive labeling including all required elements
6. Consider need for clinical testing based on device novelty
7. Document material specifications and compatibility with disinfectants
8. Prepare patient implant card and instructions
9. For coated devices, provide additional coating characterization and performance data
10. Consider pre-submission consultation for novel features or materials

Key Considerations

Clinical testing

• Clinical testing generally not required except for:
  • Subcutaneous catheters
  • A-V shunt cannulae
  • New coatings/materials requiring clinical validation
• Must demonstrate safe and effective use and capture adverse events when required

Non-clinical testing

• Pressure vs flow rates testing for arterial and venous lumens
• Recirculation rates testing in forward and reverse flow
• Priming volumes determination
• Tensile testing of joints and materials
• Air and liquid leakage testing
• Repeated clamping simulation testing
• Mechanical hemolysis testing for new designs
• Chemical tolerance testing to disinfection agents

Labelling

• Must include arterial and venous pressure vs flow rates
• Must specify forward and reverse recirculation rates
• Must provide priming volumes
• Must specify expiration date
• Must identify incompatible disinfecting agents
• Must include patient implant card
• Must include comprehensive instructions for preparation, care, maintenance and removal

Biocompatibility

• Components in human contact must be demonstrated biocompatible
• Testing should follow ISO 10993 for:
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Systemic toxicity
  • Sub-chronic toxicity
  • Implantation
  • Hemocompatibility
  • Genotoxicity

Safety

• Must demonstrate device performs as intended under anticipated conditions
• Must include sterility validation
• Must support shelf-life claims
• Special safety considerations for subcutaneous catheters and A-V shunt cannulae

Other considerations

• Special requirements for coatings and additives including:
  • Material characterization
  • Duration of effectiveness
  • Performance data
  • Appropriate warnings for allergens

    Relevant Guidances

• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
• Submission Requirements for Terminally Sterilized Medical Devices

Related references and norms

• ISO 10993: Biological Evaluation of Medical Devices
• ISO 10555-1: Sterile, single-use intravascular catheters – General requirements
• ISO 80369: Small-bore connectors for liquids and gases in healthcare applications
• ASTM F1830-97: Standard practice for selection of blood for in vitro evaluation of blood pumps
• ASTM F1841-97: Standard practice for assessment of hemolysis in continuous flow blood pumps
• ASTM F1980-7: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

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Original guidance

• Special Controls for Implanted Blood Access Devices for Hemodialysis
• HTML / PDF
• Issue date: 2016-01-21
• Last changed date: 2019-02-09
• Status: FINAL
• Official FDA topics: Medical Devices
• ReguVirta summary file ID: e7c69ae09d4d7b94d2c06c1b3eeb35d6