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U.S. Department of Health and Human Services

Advisory Committees

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Brief Summary From the Gastroenterology and Urology Devices Panel – June 8, 2005

On June 8, 2005, the Gastroenterology and Urology Devices Advisory Panel met to discuss and make recommendations regarding general issues related to the premarket requirements for the safe and effective use of hemodialysis equipment labeled for nocturnal home hemodialysis (NHHD) therapies.

The panel members gave their recommendations regarding the safety features that the hemodialysis machines should include and safeguards that the patient should use in order to make this practice as safe as possible. The panel members gave recommendations on the monitors and alarms for the sleeping patient. They discussed that the quality of water at home should be the same as the clinic. The major risk of NHHD was thought to be inadvertent disconnection of the blood lines. The panel discussed study design for small clinical trials prior to product clearance to demonstrate safety and effectiveness of these products. The panel stated that training the patient for NHHD is the physician’s responsibility. They also discussed the training the manufacturer is responsible for, namely training to use the device properly. The panel thought patient labeling is best incorporated into the machine and physician labeling should include a discussion of how the device was determined to be safe and effective

Contact: Jeffrey Cooper, D.V.M., Executive Secretary, 301-594-1220, x121

Transcripts may be purchased from: (Written Request Only)

Neal R. Gross & Company
1323 Rhode Island Avenue, N.W
Washington, D.C. 20005
202-234-4433

-or-

Transcripts or Executive Summaries may be purchased from:

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

Advisory Committee Database