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Quality Assurance Guidelines for Hemodialysis Devices and Facilities

This guidance provides quality assurance guidelines for hemodialysis devices to ensure safe and effective performance. It covers water treatment equipment, dialysate delivery systems, dialysate concentrates, dialyzers, ancillary devices, anticoagulation, vascular access devices, and reuse of dialyzers. The guidance aims to help dialysis facilities develop and implement facility-specific quality assurance programs.

  1. Develop comprehensive written policies and procedures for all aspects of dialysis operations
  2. Implement staff training program with competency assessments
  3. Establish equipment maintenance and calibration schedules
  4. Create monitoring protocols for water quality, dialysate, and patient safety
  5. Document all quality control testing and results
  6. Develop incident reporting and investigation procedures
  7. Conduct regular audits of procedures and documentation
  8. Review and update quality assurance program annually
  9. Maintain records of all quality assurance activities
  10. Ensure proper handling and storage of supplies and chemicals
  11. Follow infection control and safety protocols
  12. Monitor patient outcomes and adverse events
  13. Validate all reprocessing procedures
  14. Calibrate test equipment regularly
  15. Document staff training and competency

Key Considerations

Clinical testing

  • Monitor patient vital signs and symptoms during dialysis
  • Track adverse events and complications
  • Validate treatment adequacy through lab tests
  • Document all clinical monitoring results

Non-clinical testing

  • Regular testing of water quality and purity
  • Monitor dialysate conductivity, pH, temperature
  • Test equipment alarms and safety features
  • Validate equipment performance specifications
  • Calibrate monitoring devices

Human Factors

  • Staff training and competency assessment
  • Documentation of procedures and protocols
  • Clear communication of roles and responsibilities
  • Regular performance evaluations

Labeling

  • Proper labeling of all solutions and concentrates
  • Documentation of equipment maintenance
  • Clear warning labels and instructions
  • Traceability of disposable items

Biocompatibility

  • Test dialyzer membrane compatibility
  • Monitor patient reactions to materials
  • Validate reprocessing procedures
  • Test for residual chemicals

Safety

  • Follow infection control procedures
  • Handle toxic chemicals appropriately
  • Maintain equipment alarms and safety features
  • Follow proper disinfection protocols

Other considerations

  • AAMI RD5-1981: American National Standard for Hemodialysis Systems
  • AAMI RD16-1984: American National Standard for First Use Hemodialyzers
  • ISO 8637: International Standard for Hemodialyzers, Hemofilters and Hemoconcentrators
  • AAMI RD47: Recommended Practice for Reuse of Hemodialyzers

Original guidance

  • Quality Assurance Guidelines for Hemodialysis Devices and Facilities
  • HTML / PDF
  • Issue date: 1991-02-01
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Gastroenterology-Urology
  • ReguVirta summary file ID: 58b41fee434f5cd7917ff371e99789c9
This post is licensed under CC BY 4.0 by the author.