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

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

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

A Standard HD Delivery System Informational Display

PT = Pressure Transducer Anticoagulant PT Saline

Blood from Patient

Blood Leak Detector

Dialysate / UF Out (green / yellow)

PT
Conductivity Meter

Dialysate In
PT

Mixing System

Water, Acid Concentrate, Bicarbonate Concentrate In

Air Detector Venous clamp

Drip Chamber

Blood return to 5 Patient

A Standard HD Delivery System Informational Display

PT = Pressure Transducer Anticoagulant PT Saline

Blood from Patient

Blood Leak Detector

Dialysate / UF Out (green / yellow)

PT
Conductivity Meter

Dialysate In
PT

Mixing System

Pre-mixed or sorbent regenerated dialysate

Drip Chamber

Air Detector

Venous clamp

Blood return to 6 Patient

Solute Transfer & Ultrafiltration

C blood > C Dialysate

P blood P Dialysate

Blood

Dialysate

Solute Transfer & Ultrafiltration

C blood > C Dialysate

P blood > P Dialysate

Blood

Dialysate

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) RD:62 standard Can be designed for multiple patients, or can be single patient
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Water Treatment Systems

Water In

Water Out Reverse Deionization Osmosis Ultrafilter

Pretreatment

Carbon Filters Worker / Polisher

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

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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 are contraindicated as the sole method of monitoring a patient during hemodialysis 17

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 18

Nocturnal Home Hemodialysis

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

Biomedical Engineer, Director Health Promotion Officer
Human Factors Science and Engineering Branch