Clinical Investigation of Nocturnal Home Hemodialysis Delivery Systems
This guidance addresses IDE applications for clinical investigation of hemodialysis delivery systems intended for Nocturnal Home Hemodialysis (NHHD). NHHD is defined as chronic hemodialysis performed at home while the patient is sleeping, typically at night, up to 7 times per week, for 6-10 hours per treatment, administered by the patient or trained partner. The guidance covers sorbent regenerated dialysate delivery systems, hemodialysis systems and accessories, and high permeability hemodialysis systems when used for NHHD.
What You Need to Know? 👇
What documentation level is required for nocturnal home hemodialysis systems under the new FDA software guidance?
Nocturnal home hemodialysis systems should generally address recommendations for an Enhanced Documentation Level under FDA’s 2023 “Content of Premarket Submissions for Device Software Functions” guidance, replacing the previous Major Level of Concern classification.
Are nocturnal home hemodialysis devices considered significant risk devices requiring IDE approval?
Yes, FDA considers NHHD systems significant risk devices under 21 CFR 812.3(m), requiring FDA-approved IDE applications and compliance with institutional review board regulations and informed consent requirements before clinical investigation.
What key safety features must be incorporated in nocturnal home hemodialysis systems?
Essential features include disinfection capabilities, conductivity monitors, air detectors, blood leak detectors, patient disconnect preventers, temperature monitors, anticoagulant systems, remote monitoring access ports, and fail-safe designs for power failures.
What biocompatibility testing is required for NHHD system components?
Biocompatibility testing following FDA-modified ISO-10993 is required for all direct and indirect patient-fluid contacting components, or alternatively, leach testing with risk assessment for dialysate-contacting materials may be conducted.
Is a care partner required during nocturnal home hemodialysis clinical studies?
Yes, FDA recommends all NHHD studies incorporate a care partner present throughout dialysis treatment, regardless of real-time remote monitoring capabilities. Remote monitoring alone is insufficient for patient safety monitoring.
What training requirements must be included in NHHD clinical study protocols?
Training must cover complete hemodialysis procedures, vascular access care, device troubleshooting, emergency procedures, maintenance, supply management, and environmental requirements. Success should be evaluated through practical tests and written assessments.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive testing plan covering all required non-clinical testing aspects
- Design and validate robust safety features and alarms suitable for home/nocturnal use
- Create detailed training program for users and care partners
- Develop comprehensive labeling including user manual and patient materials
- Establish home environment assessment protocol
- Design monitoring protocol including care partner presence requirements
- Create water quality and dialysate monitoring procedures if applicable
- Implement human factors validation program
- Develop detailed investigational plan including in-clinic and home use periods
- Establish clear subject selection criteria including home environment suitability
Key Considerations
Clinical testing
- Study should include in-clinic period followed by home-use period
- Compare assessments between in-clinic and home use periods
- Evaluate adverse events, ability to deliver prescribed treatments, and device reliability
- Care partner must be present throughout dialysis treatment
- Remote monitoring should not be sole method of patient monitoring
Non-clinical testing
- Functional testing under standard and worst-case conditions
- System-level hazard analysis including use errors
- Electrical safety testing
- EMC testing at 10 V/m level for home environment
- Performance testing of remote alarm transmission capabilities
- Testing of dedicated tubing sets if applicable
Human Factors
- Validation of patient/user interface considering human factors and ergonomics
- Non-clinical usability study demonstrating safe device performance by prospective users
- Training evaluation and assessment of user comprehension
- Practical tests to assess subject’s understanding
Software
- Major level of concern documentation required
- Software validation according to FDA guidance
Labelling
- Operator’s manual with therapy background, device description, operation instructions
- Patient labeling in layman’s terms
- Pre-treatment setup checklist
- List of alarms and troubleshooting directions
- Environmental requirements and supplies needed
Biocompatibility
- Testing for all direct/indirect patient-fluid contacting components
- Tests appropriate for duration and level of patient contact
- Alternative leach testing and risk assessment for indirect contact materials
Safety
- Multiple safety features required (air detection, blood leak detection, etc.)
- Alarms must be able to awaken sleeping users
- Fail-safe design features for power failure
- Disinfection and cleaning capabilities
Other considerations
- Water quality monitoring for systems not using pre-mixed dialysate
- Home environment inspection requirements
- Training requirements for users and care partners
- Supply management procedures
Relevant Guidances đź”—
- Design Considerations for Medical Devices Intended for Home Use
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms đź“‚
- IEC 60601-1: Medical Electrical Equipment – Part 1: General Requirements for Safety
- IEC 60601-1-2: Medical Electrical Equipment – Part 1-2: General Requirements for Safety; Electromagnetic Compatibility
- IEC 60601-1-8: Medical electrical equipment Part 1-8: General requirements for safety - Collateral standard: general requirements, tests and guidance for alarm systems
- ISO 14972: Risk management standard
- AAMI/ANSI HE74:2001: Human Factors Design Process for Medical Devices
- AAMI RD62:2001: Water treatment equipment for hemodialysis applications