FDA Issues Dialysis Alert

The FDA is issuing a nationwide safety alert over malfunctioning dialysis equipment that may have exposed patients to each other's blood.

The malfunctions have been reported at four treatment centers in New Jersey, Arizona, Florida and Pennsylvania, FDA officials said Tuesday.

A dialysis machine filters a patient's blood through an artificial kidney when his own kidneys don't work. The machine controls blood that flows through tubing to the machine, where poisons are cleansed from the blood through a filter.

The risk that patients were exposed to others' blood, and thus to blood-borne diseases, is "extremely remote," said Steven Niedelman, an enforcement director for the FDA's Center for Medical Devices and Radiological Health in Rockville, Md.

But he said there is a concern because traces of blood were found in tubing inside the machines. There has been no evidence that any blood has passed through internal filters, though in several instances it has breached a quarter-sized external filter that normally is impervious to penetration.

"We don't really know the extent of the problem or what's causing the problem, so it's really a concern to us," Niedelman said.

FDA spokeswoman Sharon Snider said the agency hasn't confirmed the tubing is the cause of the problem.

The manufacturer of blood-tubing used in the dialysis procedure, Miami-based Nissho Nipro Corp. Ltd., told the FDA on Friday it is voluntarily recalling 154,000 tubing sets nationwide as a precaution. The company has distributed 2.1 million tubing sets in the United States during the past year.

"Nissho Nipro is aware of reports from four facilities that use dialysis machines where small amounts of blood may have penetrated through the filters of its blood tubing to contaminate machines," the company said in a statement.

Tom Kelly, a spokesman for Nipro's distributor, Althin Medical, added, "We don't know if there's a problem with the lines. There are several instances where there's been reported blood contamination in the pressurizing monitoring lines in the dialysis machine."

Officials at St. Mary's Hospital in Tucson said last month that 121 kidney dialysis patients faced months of blood tests to determine whether they were exposed to blood of other patients possibly infected with HIV, hepatitis or other infections.

Since December, there also have been incidents of blood contamination of dialysis equipment detected at Total Renal Care, a dialysis center in Miami Lakes, Fla; Lee Regional Hospital in Johnstown, Pa., and Bayonne Hospital in Bayonne, N.J., the FDA said.

Niedelman said the FDA hasn't investigated the Johnstown or Bayonne facilities yet. The other situations are reported to be similar incidents, Niedelman said.

Patricia Katarski, director of marketing for University of Pittsburgh Medical Center-Lee Regional Hospital, in Johnstown, said hospital staffers expressed concern about the tubing in February during a rgular quality control check.

The hospital notified Althin, the distributor, and reported it to the FDA. No patient contamination was found, she said.

Spokeswoman Michelle Weiss said Bayonne Hospital, which completed 13,671 dialysis treatments in 1998, used Althin-provided tubing for two days in January. The equipment was taken out of service after nurses became concerned about a problem moving blood through the middle of the line.

"A limited number of patients" were treated with the tubing and no one was contaminated, Weiss said.

In Tucson, St. Mary's officials said they believe the tubing somehow may have allowed minute amounts of blood to penetrate the machine.

Niedelman said in no instances was there "any bloody mess" inside a machine. "It's that the blood entered the machine, but did not go all through the machine," he said.

Written By Arthur H. Rotstein