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.
Recommended Actions
- Develop comprehensive written policies and procedures for all aspects of dialysis operations
- Implement staff training program with competency assessments
- Establish equipment maintenance and calibration schedules
- Create monitoring protocols for water quality, dialysate, and patient safety
- Document all quality control testing and results
- Develop incident reporting and investigation procedures
- Conduct regular audits of procedures and documentation
- Review and update quality assurance program annually
- Maintain records of all quality assurance activities
- Ensure proper handling and storage of supplies and chemicals
- Follow infection control and safety protocols
- Monitor patient outcomes and adverse events
- Validate all reprocessing procedures
- Calibrate test equipment regularly
- 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
- Quality assurance program documentation
- Regular review and updates of procedures
- Incident reporting and investigation
- Equipment maintenance records
Relevant Guidances
- Hemodialysis Blood Tubing Sets - Performance, Testing, and Labeling Requirements
- Clinical Investigation of Nocturnal Home Hemodialysis Delivery Systems
- Special Controls for Implanted Blood Access Devices for Hemodialysis
Related references and norms
- 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
This post is licensed under CC BY 4.0 by the author.