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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

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

overview
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
disclaimer
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
hemodialysis delivery systems
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”
slide5

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

slide6

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

solute transfer ultrafiltration
Solute Transfer & Ultrafiltration

C blood > C Dialysate

P blood ≈ P Dialysate

Blood

Dialysate

solute transfer ultrafiltration8
Solute Transfer & Ultrafiltration

C blood > C Dialysate

P blood > P Dialysate

Blood

Dialysate

monitored hd parameters
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
hd alarms
HD Alarms

Typically come in two varieties:

CAUTION

WARNING

standard hd alarms
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
accessory devices
Accessory Devices
  • Water Treatment Systems
  • HD Blood Tubing
  • Remote Monitoring Systems
  • Blood Access Devices
water treatment systems
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
water treatment systems14
Water Treatment Systems

Water In

Water Out

Deionization

Reverse Osmosis

Pre-treatment

Carbon Filters

Worker / Polisher

Ultrafilter

Data Out

blood tubing
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
blood tubing16
Blood Tubing
  • Can be “cassette” based, which limits the number of user connections needed
  • Kinked tubing can cause hemolysis, which can lead to death
remote monitoring systems
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
blood access devices
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
nocturnal home hemodialysis

Nocturnal Home Hemodialysis

Michael Mendelson, D.D.S., M.S.

Biomedical Engineer, Director Health Promotion Officer

Human Factors Science and Engineering Branch