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Overview of Conventional Hemodialysis Delivery Devices

Overview of Conventional Hemodialysis Delivery Devices. Joshua C. Nipper, M.E. Biomedical Engineer Gastroenterology and Renal Devices Branch Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health June 8, 2005.

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Overview of Conventional Hemodialysis Delivery Devices

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  1. Overview of Conventional Hemodialysis Delivery Devices Joshua C. Nipper, M.E. Biomedical Engineer Gastroenterology and Renal Devices Branch Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health June 8, 2005

  2. Overview • Conventional Hemodialysis (HD) Systems • A “standard” device • Monitored parameters • Alarms • Accessory Devices • Water treatment systems • Hemodialysis blood tubing • Remote monitoring systems • Blood access devices

  3. Disclaimer • Any examples in this presentation are not intended as an endorsement or criticism of any specific technology, device or company • No devices are currently cleared for nocturnal home hemodialysis

  4. Hemodialysis Delivery Systems • Classified under two different sections of the Code of Federal Regulations (CFR): • 21 CFR §876.5820 for a low permeability system • 21 CFR §876.5860 for a high permeability system (ultrafiltration controller) • Suggestions for the content of a 510(k) submission found in the FDA guidance document: “Guidance for the Content of Premarket Notifications for Hemodialysis Delivery System”

  5. A “Standard” HD Delivery System Informational Display Saline PT = Pressure Transducer Anticoagulant PT Blood from Patient Dialysate / UF Out (green / yellow) Blood Leak Detector Conductivity Meter PT Mixing System Dialysate In Water, Acid Concentrate, Bicarbonate Concentrate In PT Venous clamp Drip Chamber Air Detector Blood return to Patient

  6. A “Standard” HD Delivery System Informational Display Saline PT = Pressure Transducer Anticoagulant PT Blood from Patient Dialysate / UF Out (green / yellow) Blood Leak Detector Conductivity Meter PT Mixing System Pre-mixed or sorbent regenerated dialysate Dialysate In PT Venous clamp Drip Chamber Air Detector Blood return to Patient

  7. Solute Transfer & Ultrafiltration C blood > C Dialysate P blood ≈ P Dialysate Blood Dialysate

  8. Solute Transfer & Ultrafiltration C blood > C Dialysate P blood > P Dialysate Blood Dialysate

  9. Monitored HD Parameters • Blood and dialysate flow rates (pump speed) • Pressure • Arterial • Venous • Dialysate • Waste / Dialysate Out • Transmembrane Pressure (TMP) • Patient fluid removed (UF) • Temperature

  10. HD Alarms Typically come in two varieties: CAUTION WARNING

  11. Temperature Blood leak Flow rates Pressure Arterial Venous Transmembrane Pressure (TMP) Dialysate Waste / Dialysate Out Excessive UF Air embolism Conductivity / pH Water quality System alarms Vascular access disconnection – venous pressure? Standard HD Alarms

  12. Accessory Devices • Water Treatment Systems • HD Blood Tubing • Remote Monitoring Systems • Blood Access Devices

  13. Water Treatment Systems • Classified under 21 CFR §876.5665 • Guidance for The Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis • Converts potable water to purified water meeting the requirements of the Association for the Advancement for Medical Instrumentation (AAMI) RD:62 standard • Can be designed for multiple patients, or can be single patient

  14. Water Treatment Systems Water In Water Out Deionization Reverse Osmosis Pre-treatment Carbon Filters Worker / Polisher Ultrafilter Data Out

  15. Blood Tubing • Serves as basic conduit for blood • Contains a “blood pump” segment • Can have multiple connection points • Patient access (arterial & venous) • Pressure transducers with transducer protectors • Air detectors • Roller / peristaltic blood pump

  16. Blood Tubing • Can be “cassette” based, which limits the number of user connections needed • Kinked tubing can cause hemolysis, which can lead to death

  17. Remote Monitoring Systems • Can be used for data transmission • Connect HD machine to Internet via modem or broadband connection • Can transmit real time alarms, and/or completed treatment data • FDA labels current systems are contraindicated as the sole method of monitoring a patient during hemodialysis

  18. Blood Access Devices • Long-term, cuffed HD Catheters • Single or double lumen • Contain luer locks meeting ISO standards for connection to blood tubing • Arterio-Venous (AV) Grafts • Implanted prosthesis designed to bypass sections of native vessels • AV Fistulas • Surgical procedure, not a device regulated by FDA • Fistula needles are medical devices, and contain the same luer locks as catheters

  19. Nocturnal Home Hemodialysis Michael Mendelson, D.D.S., M.S. Biomedical Engineer, Director Health Promotion Officer Human Factors Science and Engineering Branch

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