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Overview of ConventionalHemodialysis Delivery Devices
Joshua C. Nipper, M.E.
Biomedical Engineer
Gastroenterology and Renal Devices Branch
Division of Reproductive, Abdominal and Radiological DevicesOffice 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
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Disclaimer
Any examples in this presentation
are not intended as an endorsement
or criticism of any specifictechnology, device or company
No devices are currently cleared fornocturnal 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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Air
Detector
Blood Leak
Detector
PT
PT = Pressure
Transducer
PT
Venous
clamp
Anticoagulant
Blood from Patient
Blood return toPatient
Dialysate In
Dialysate / UF Out
(green / yellow)
Informational Display
A Standard HD Delivery System
PT
Mixing
System
Conductivity
Meter
Water, Acid
Concentrate,
Bicarbonate
Concentrate In
Saline
Drip Chamber
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Air
Detector
Blood Leak
Detector
PT
PT = Pressure
Transducer
PT
Venous
clamp
Anticoagulant
Blood from Patient
Blood return toPatient
Dialysate In
Dialysate / UF Out
(green / yellow)
Informational Display
A Standard HD Delivery System
PT
Mixing
System
Conductivity
Meter
Pre-
mixed or
sorbent
regenerated
dialysate
Saline
Drip Chamber
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Solute Transfer & Ultrafiltration
C blood > C Dialysate
P blood P Dialysate
Blood Dialysate
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Solute Transfer & Ultrafiltration
C blood > C Dialysate
P blood > 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
TransmembranePressure (TMP)
Dialysate
Waste / DialysateOut
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 MedicalInstrumentation (AAMI) RD:62 standard
Can be designed for multiple patients, orcan be single patient
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Water Treatment Systems
Reverse
Osmosis
DeionizationCarbon Filters
Worker / Polisher
Water Out
Data Out
ater In
Ultrafilter
Pre-
treatment
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Blood Tubing
Serves as basic conduit for blood
Contains a blood pump segment
Can have multiple connection pointsPatient access (arterial & venous)
Pressure transducers with transducer
protectorsAir 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
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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 arecontraindicated 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 bypasssections 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
