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
when he was in
his 30s, as did a
. For now, dialysis keeps him
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
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
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
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.
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
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
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
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
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
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
Says Eknoyan, "Prevention is going to be a big part of the
Please be aware that this information is provided to supplement the care
provided by your physician. It is neither intended nor implied to be a
substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER
IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the
advice of your physician or other qualified health provider prior to
starting any new treatment or with any questions you may have regarding a