A Way of Life

As he has for the last seven years, Tony Robinson, 47, heads straight from work on Monday, Wednesday, and Friday afternoons to a nearby hemodialysis center in Orlando, Florida.

A nurse gives him a checkup, then Robinson settles into one of the recliners circling the room. Propping his left arm up, he allows a technician to slip two needles into blood vessels near his wrist. The needles—one to capture the blood and the other to return it—are attached to plastic tubes leading to a dialysis machine beside the chair.

For the next three hours, this device, which looks like a tall, narrow, automated teller machine, removes wastes and extra fluid from Robinson's blood. He passes the hours by reading, watching the evening news, and sometimes dozing.

Robinson was born with only one kidney. It failed when he was in his 30s, as did a kidney transplant . For now, dialysis keeps him alive.

Except for the initial needle stick, the procedure doesn't hurt. "You never get used to the needles, you just learn to handle them," he says with a laugh. "Sometimes I feel sick to my stomach if my blood pressure drops, but other than that, it's not bad."

Robinson is one of approximately 354,000 Americans who receive ongoing dialysis. Since the late 1960s, the procedure has been used in place of kidneys lost to disease, birth defects, or injury. It can be used temporarily until the kidneys resume function or the patient receives a transplant, or for years if those options are not available.

With dialysis, Robinson and many others like him can live full and active lives. In fact, Robinson works full-time as an investigator with the Food and Drug Administration's Orlando office. His job requires him to walk distances through production plants, climb ladders, and lift boxes to inspect products. He travels to cities all over Florida to conduct inspections. The overnight trips are not a problem as long as he schedules dialysis ahead of time in the cities he visits.

"If a dialysis patient is otherwise healthy, they should be afforded the opportunity to work," says Robinson. "No one should say you're disabled or restricted to certain areas. I travel, go to training, do inspections—and I have since 1990. I've gotten adjusted to arranging things around the treatments."

Dialysis Under Scrutiny

Since the 1960s, surveillance studies have consistently shown that American dialysis patients do not live as long as those in other countries. A number of factors seem to be the cause. As a whole, American clinics perform hemodialysis treatments for a shorter length of time than in other countries, both because reimbursement doesn't increase for lengthier treatments and patients don't want to sit for five or six hours, according to Dr. Garabed Eknoyan, president of the National Kidney Foundation and professor of medicine at Baylor College of Medicine in Houston, Texas. "If you talk to any of the patients, you'll find it's hard to convince them to stay five hours. They come in late and want to leave early."

In addition, says Barbara McCool, a nurse and senior scientist in FDA's Office of Device Evaluation, "We dialyze older and sicker patients than do other countries, including AIDS patients, who do not withstand the rigors of dialysis very well." Because of the need to cut costs, American dialysis clinics reuse much of the dialysis equipment and employ staff who have minimal technical training. Many experts say this may be a risk to patient care.

The quality between clinics within the United States varies as well. Most clinics operate for profit; others do not. Some are located in teaching hospitals, while some are in more remote areas. Some have doctors on site every day, while others only have them on call. These factors result in a wide range of quality of care. "We may all read the same books and have the same science, but we're using it differently," says Eknoyan.

In response to these concerns, many scientific and medical groups, including the National Kidney Foundation and FDA, are working to improve the quality of dialysis care nationwide.

FDA has increased its involvement in regulating the reuse of dialysis equipment. The agency does not inspect dialysis clinics—that is the responsibility of each state health department. FDA approves the equipment used in dialysis, and the agency has begun requiring that hemodialyzer filters and tubes be tested and approved in realistic clinical situations.

For example, in about 80% of hemodialysis treatments, the equipment is reused to cut costs, although it was originally tested, labeled, and approved for one-time use only. FDA is now requiring manufacturers to prove that filters and tubes are safe and effective when reused. The government agency is also taking a closer look at water purifying equipment used in dialysis. Pure water is crucial to hemodialysis, since impurities can kill a patient. FDA has recently begun enforcing regulations that require the manufacturers of water purifiers to prove their devices are safe and effective.

FDA has produced numerous training videos and documents to inform dialysis clinicians about the importance of making sure their equipment is used properly and meets FDA requirements. In addition, the agency has met with many manufacturers of dialysis equipment to help them meet requirements for marketing their devices in the United States. FDA also maintains MedWatch, an adverse events reporting hot line that helps the agency track medical device problems.

"We're hoping to enhance communications with dialysis providers and consumers," says Marie Reid, a nephrology nurse in FDA's Office of Surveillance and Biometrics. "Whenever there's an adverse event, we look at it to identify the problem and learn how we can help prevent it from happening again."

The National Kidney Foundation, as well as others in the renal (kidney) care community, has been trying to improve quality in dialysis clinics nationwide. The foundation led an extensive project for the last two years to develop quality guidelines for dialysis treatment nationwide. If dialysis providers adopt the voluntary guidelines, experts say patients will benefit because the latest information on quality treatment will be available in even the smallest dialysis clinics.

The Dialysis Process

Dialysis acts as an artificial kidney. There are two types of treatment: hemodialysis and peritoneal dialysis. About 90% of dialysis patients receive hemodialysis, in which the blood is circulated outside the body and cleaned inside a machine before returning to the patient.

Before hemodialysis can be done, a doctor must make an entrance, called an access, into the patient's blood vessels. This is done by minor surgery in the leg, arm, or sometimes neck. The best access for most patients is called a fistula. Minor surgery is performed to join an artery to a vein under the skin to make a larger vessel.

If no vessels are suitable for a fistula, the doctor might use a soft plastic tube called a vascular graft to join an artery and vein under the skin. For temporary dialysis in the hospital, a patient might need a catheter implanted into a large vein in the neck. Once the access is made and healed, two needles are inserted in the fistula or graft, one on the artery side and one on the vein side.

Blood drains into the dialysis machine to be cleaned. The machine has two parts, one side for blood and one for a fluid called dialysate. A thin, semipermeable membrane separates the two parts. As dialysate passes on one side of the membrane, and blood on the other, particles of waste from the blood pass through microscopic holes in the membrane and are washed away in the dialysate. Blood cells are too large to go through the membrane and are returned to the body.

The benefits of hemodialysis are that the patient requires no special training, and he or she is monitored regularly by someone trained in providing dialysis.

The other type of treatment, peritoneal dialysis, uses the patient's own peritoneal membrane as a filter. The peritoneal membrane is a sac around the abdominal organs. This membrane (like the dialysis machine membrane) is semipermeable. Waste particles can get through it, but larger blood cells cannot.

The patient has a plastic tube called a peritoneal catheter surgically implanted into the belly. He or she slowly empties about two quarts of dialysate fluid through the catheter into the abdomen. As the patient's blood gets exposed to the dialysate through the peritoneal membrane, impurities in the blood are drawn through the membrane walls and into the dialysate. The patient drains out the dialysate after three or four hours and pours in fresh fluid. The draining takes about half an hour and must be repeated about five times a day. This is called continuous ambulatory peritoneal dialysis (CAPD).

The main benefit of CAPD is freedom—the patient doesn't have to stay at a dialysis clinic several hours a day, three times a week. The dialysate can be exchanged in any well-lit, clean place, and the process is not painful. The drawback to this treatment is that some people get an infection of their peritoneal lining, and the process may not work well enough on very large people.

Children often do a similar type of dialysis called continuous cycling peritoneal dialysis (CCPD). Their treatments can be done at night while they sleep. A machine warms and meters dialysate in and out of their abdomens for 10 hours continuously. Then they are free from treatments during the day.

As a college student in the spring of 1985, Kris Robinson chose CAPD when her kidney (she was born with only one) began to fail.

Doctors quickly determined Robinson would need dialysis until a kidney transplant could be done. Robinson's father was willing and able to give her one of his kidneys, and for several months before the operation was arranged, she drained dialysate in and out of her abdomen five times a day. She became adept at draining it out in the shower, putting fresh fluid in during breakfast, and so on throughout the day.

"I'm extremely independent," Robinson says. "This let me be in charge of my own dialysis. I knew I could do it, and I wanted to be responsible for my own care. I didn't like to have to sit for four hours, three times a week, and I didn't like the idea of dealing with my own blood in such an open way as in hemodialysis."

The transplant from her father was successful and today Robinson, now 40, still has her kidney transplant and is the executive director of the American Association of Kidney Patients in Tampa, Florida, a nonprofit organization dedicated to patient education about dialysis and kidney disease.

One thing all dialysis patients must know a great deal about is diet. They need a good amount of protein and lower amounts of potassium and phosphate, which tend to accumulate in the blood and cannot be removed very well with treatment. French fries, for example, are off-limits, and ice cream and cheese must be eaten with caution. Dialysis patients also must limit fluids because the treatment removes only a certain amount of water. Excess fluids make body tissues swell.

Dialysis in the Future

The first successful artificial kidney was developed in the 1940s by a Dutch physician, Willem J. Kolff. Because of World War II and the Nazi occupation of his country, he improvised many materials. For example, he used sausage-link casing for the semipermeable membrane. Since then, the process of dialysis has been fine-tuned over the years, and semipermeable membranes and dialysate have improved.

Still, dialysis is not a cure. If a person's kidneys are temporarily damaged, dialysis can give them a rest and a chance to recover. But for chronic, end-stage renal disease, a kidney transplant is the only long-term solution that frees a patient from dialysis.

Living relatives can donate a kidney if their remaining organ is healthy. Even with a kidney from a close relative, however, a transplant recipient must take drugs to suppress the immune system from rejecting the organ. There are about three times as many people waiting for transplants as there are kidneys available.

Some dialysis patients are not well enough for the rigors of a transplant operation and the drugs that follow, according to Robinson of the American Association of Kidney Patients. In fact, 20% of dialysis patients are over 65. More than half suffer from other illnesses, such as diabetes and high blood pressure . Some patients receive transplants only to have them rejected by their immune system later. In these cases, what solutions will technology bring?

"I think everything will be different in the future," predicts Eknoyan of the National Kidney Foundation. "People are working on fine-tuning dialysis and improving the technology. For instance, they are trying to develop ways to put essential substances back into the blood while taking the impurities out."

Perhaps kidney transplants, always in shortage, will become easier to get if animals such as pigs are used as donors, Eknoyan adds. But the best treatment, of course, is to protect healthy kidneys in the first place. Diabetes and high blood pressure account for more than half of all cases of end-stage renal disease. Both of these conditions usually can be managed with proper medical care.

Says Eknoyan, "Prevention is going to be a big part of the answer."