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Dialysis deaths spark recall Manufacturer pulls more than 10,000 blood tubing sets; 'We're still investigating'; Faulty equipment may have caused illnesses at clinics

THE BALTIMORE SUN

Health authorities concluded yesterday that something as simple as a blocked tube in dialysis equipment may have killed two men in Maryland and sickened more than 30 dialysis patients nationwide.

Specifically, the tube that carries blood from the patient to the machine was partially blocked, according to the manufacturer, Gambro Healthcare. The Colorado-based company recalled more than 10,000 of these blood tubing sets last night. Officials were trying to contact 31 dialysis clinics in many states that had been sent the defective equipment.

The problem first cropped up in Maryland, Nebraska and Massachusetts last week. Investigators had suspected a piece of equipment that all the clinics shared, because patients had similar symptoms. The strange cluster of cases sparked the closure of several centers in these states, including three in Maryland, and frightened thousand of dialysis patients across the country.

Two men treated at Bon Secours Baltimore Health System's dialysis clinics died, but scientists are trying to determine if defective tubing was to blame. One elderly man died of a heart attack at St. Agnes Hospital. A second man died at North Arundel Hospital. Officials would not release further details.

Eleven other Maryland patients remained hospitalized last night, the majority at Bon Secours Hospital, said Dr. Juan Beltran, medical director of the hospital's dialysis program. Two of these patients were in intensive care after unrelated surgery.

The three Bon Secours dialysis clinics where patients had gotten sick are set to re-open today, according to officials with Bon Secours. The clinics are located at 2000 W. Baltimore St., 5208 Baltimore National Pike in Charing Cross, and 120 N. Langley Road in Glen Burnie. The faulty tubing has been removed from the three centers. But Dr. Diane Dwyer, director of epidemiology and disease control at the state Department of Health and Mental Hygiene,said she is working with another dialysis clinic in Maryland, which also received a shipment of the defective product.

She would not identify the center because the investigation is incomplete. She said that the damaged tubes have not been used, and there have been no additional cases.

Dwyer was one of many investigators collaborating by phone and fax over the Memorial Day weekend. The national Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and state health authorities were all involved.

Dwyer said she was relieved that they found the answer so quickly.

'Product recall issue'

"The hospital [Bon Secours] is entirely safe. There was risk to no one except dialysis patients," Dwyer said. "This isn't a health care issue. This is a product recall issue."

But investigators must still determine why just 13 of the 300 Marylanders who were dialyzed with those faulty tubes got sick.

"Other people were exposed, but we only had these 13 cases," Dwyer said. "We're still investigating why."

Other states are also looking for answers.

In Lincoln, Neb., 14 people suffered shortness of breath, chest pains and other symptoms while undergoing dialysis in a hospital and a dialysis clinic. Four of the 14 were hospitalized, and at one point, one patient was in critical condition.

In Burlington, Mass., a northwest suburb of Boston, five patients were hospitalized with a similar syndrome, and a seven-bed dialysis unit was shut down. Officials at Lahey Clinic Medical Center said last night that one patient had been discharged and they planned to reopen their clinic today.

How dialysis works

Dialysis patients already suffer from serious medical problems, such as diabetes and high blood pressure, and because their kidneys do not work, they must rely on dialysis to live. They go to a clinic three times weekly to have machines cleanse their blood of waste products.

That means that a patient's blood must go through a tube into a machine to be filtered, then brought back out by another tube to the patient.

The faulty tubing was apparently partially blocked in one section, causing pressure or turbulence in the bloodstream. This produces a serious condition called hemolysis, doctors said.

In hemolysis, red blood cells break and burst, losing their precious cargo of oxygen. Some of the patients affected by this condition started experiencing shortness of breath, chest pain and other symptoms while they were undergoing dialysis. Others developed symptoms later. Depending on a patient's condition, hemolysis can spark a range of health problems, from a simple symptom in one person, to a catastrophe in another, said Dr. Bayinnah Shabazz, a nephrologist at Bon Secours who treated many of the patients.

Vulnerability

The entire episode highlights the vulnerability of the roughly 200,000 dialysis patients nationwide, whose health hinges on equipment being sterile, water being purified and alert staffers watching for problems. The population of dialysis patients is growing by about 7 percent to 9 percent a year.

One Baltimore dialysis patient who did not want to be identified said she was upset.

She's been having dialysis for the past five years because of her diabetes and hypertension. "I know what this is about: You either do or you don't. You live by going or you die by not going," said the 73-year-old woman.

Along with 150 other dialysis patients, she was called at home Saturday afternoon and told to go to an Independent Dialysis Foundation clinic, because hers was closed. She reported that the clinic took good care of her.

All the displaced patients were shifted to centers run by Independent Dialysis Foundation, a Maryland company that runs nine free-standing dialysis centers and a few hospital-based ones. Stella Carton, the company's director of operations, said she called in staff during the holiday weekend and opened two sites that are usually closed Saturday evening and Sunday. They managed to get in dialysis sessions for Bon Secours' more than 150 patients during that time. If the clinic closures had occurred in the middle of a week, when their own patients are getting dialyzed, Carton said they could have created more shifts late in the evenings and overnight.

"It was a lot of team effort and a lot of work to get this all accomplished," Carton said. "The staff knew there was a crisis, and they were very willing to come in."

At other centers, such as the White Marsh Dialysis Center, administrators were on the alert, asking nurses to check patients' vital signs every 15 to 30 minutes. Jonathan Hazman, the center's president and administrator, said he worries that in the push to cut costs, patient care at some centers is suffering.

'On their toes'

But for now, at least, he said, "this has everybody in the industry on their toes."

Dialysis centers have come under increased scrutiny. Two years ago, the General Assembly passed a law that gives state officials stronger authority over dialysis centers, including the ability to revoke or restrict a license. New regulations under the law are going through the approval process, said Carol Benner, director of licensing and certification administration at the health department.

Benner's office already surveys dialysis clinics, but the office is only able to get to about 10 percent of clinics a year. A separate program, the kidney disease program, inspects clinics once a year, but has little enforcement power.

In dialysis centers, inspectors typically look at such areas as cleanliness, infection control and the qualifications of the staff. They also examine quality control, the equipment, and preventive maintenance on the equipment.

"So much is happening outside of a hospital today that there are growing concerns about quality," Benner said. Ambulatory surgery centers, birthing centers and diagnostic centers will also be included under the new rules.

Pub Date: 5/26/98

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