Overview of Conventional Hemodialysis Delivery Devices

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

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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

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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

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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
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Solute Transfer Ultrafiltration
C blood gt C Dialysate P blood P Dialysate
Blood
Dialysate
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Solute Transfer Ultrafiltration
C blood gt C Dialysate P blood gt P Dialysate
Blood
Dialysate
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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

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HD Alarms

• Typically come in two varieties

CAUTION
WARNING
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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?

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Accessory Devices

• Water Treatment Systems
• HD Blood Tubing
• Remote Monitoring Systems
• Blood Access Devices

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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)
  RD62 standard
• Can be designed for multiple patients, or can be
  single patient

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

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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

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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

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Nocturnal Home Hemodialysis

• Michael Mendelson, D.D.S., M.S.
• Biomedical Engineer, Director Health Promotion
  Officer
• Human Factors Science and Engineering Branch