blood exposure from dialysis

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Subj: [HEALTHE] More problems discovered with dialysis machines

More dialysis centers reporting problems, says FDA

Associated Press

By ARTHUR H. ROTSTEIN

TUCSON, Ariz. (May 22, 1999)

The number of dialysis centers around the nation reporting problems with

the machines increased to 11 after a government alert that warned

malfunctioning tubing could expose patients to each other's blood.

Some of the 11 centers and hospitals have alerted their patients to the

equipment problems, including blood leaks inside dialysis machines, and

said they'll conduct regular blood tests for exposure to hepatitis or

HIV.

The Food and Drug Administration issued a nationwide safety alert last

week to all dialysis centers because of the chance that malfunctioning

equipment potentially exposed patients to contaminated blood.

At the time, four centers had reported some problem with tubing used

extensively in the dialysis process.

Since the FDA's alert, another seven centers have notified the agency of

problems, and it is continuing to investigate to determine " the exact

nature of the problem and what is causing it, " spokeswoman Sharon Snider

said Friday.

The machines are used to cleanse the blood of deadly toxins when the

kidneys fail. There is concern because traces of blood were found in

tubing inside the machines, Niedelman, an enforcement director

for the FDA's Center for Medical Devices and Radiological Health in

Rockville, Md., said last week. Filters are supposed to prevent that

from happening.

He said the risk that patients were exposed to blood-borne diseases was

" extremely remote. "

Nipro Medical Corp., which manufactures the tubing, has voluntarily

recalled 154,000 tubing sets.

St. 's Hospital in Tucson, one of the first centers identified, told

its 121 dialysis patients about potential problems. Officials also told

patients they would undergo blood tests for possible exposure to HIV,

hepatitis or other blood-borne infections.

At the University of Pittsburgh Medical Center's Lee Regional Hospital

in stown, Pa., spokeswoman Anne McGrath said no blood leaked within

the dialysis machines and none of 67 patients was exposed.

None of the other centers said anyone had been exposed to contaminated

blood. Several did not return calls seeking comment, and some said

blood testing would be offered.

The other centers are Bayonne Hospital in Bayonne, N.J.; Total Renal

Care in Miami Lakes, Fla.; Dialysis Clinic of Oak Ridge, Tenn.; Maine

General Medical Center in Waterville, Maine; Mercy Hospital Medical

Center in Des Moines, Iowa; Methodist Hospital in Houston; Cape County

Regional Dialysis Center in Cape Girardeau, Mo.; Bay Health Medical

Center in Dover, Del.; and the Veterans Affairs Medical Center in

Wilkes-Barre, Pa.

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