Living Day-to-Day with Kidney Dialysis

[FDA]

[1]FDA Home Page [2]Table of Contents

_________________________________________________________________

[U.S. Food and Drug Administration]

Living Day-to-Day with Kidney Dialysis

Quality Improvements Continue for Devices and Clinics

by Rebecca D. Williams

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, Fla.

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 on my stomach if my blood
pressure drops, but other than that, it's not bad."

Robinson is one of approximately 217,000 Americans who receive ongoing
dialysis, at an annual cost of $11.1 billion nationwide. 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--the U.S. mortality rate for dialysis patients is about 23
percent, twice the rate of patients in Western Europe or Japan.

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. And 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 don't. Some are located in
teaching hospitals, while some are in more remote rural 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 percent 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. FDA 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.

_How Dialysis Works_

Dialysis acts as an artificial kidney. There are two types of
treatment: hemodialysis and peritoneal dialysis. About 90 percent 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
32, still has her kidney transplant and is the executive director of
the American Association of Kidney Patients in Tampa, Fla., 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 percent 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. Some patients refuse transplants. For them, says Robinson,
dialysis may be something of a social gathering and a way to be
monitored and cared for by a group of health-care providers that
become like friends.

Dialysis survival in the United States after one year is 77 percent,
according to the National Center for Health Statistics. After five
years it is 28 percent, and after 10 years it is about 10 percent.
Transplant survival rates are higher: 77 percent of patients survive
10 years after a living-relative donor. Many experts point out there
is room for improvement in the survival rate and quality of life for
American dialysis patients.

"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 (see article below, "Take Care
of Your Kidneys").

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

Rebecca D. Williams is a writer in Oak Ridge, Tenn.

_________________________________________________________________

To report a problem with dialysis equipment, call MedWatch at
1-800-FDA-1088.

_________________________________________________________________

Take Care of Your Kidneys

illustration of the urinary system

Healthy kidneys are the body's cleaning crew. Located under the rib
cage in the lower back, these twin bean-shaped organs, each the size
of a fist, filter out extra water, minerals, and toxins dumped into
the blood by the body's other organs.

Kidneys process 18 gallons of blood each hour with a sophisticated
method of excretion, absorption and re-absorption. By the end of each
day, they can produce as much as 7 gallons of urine.

The kidneys are reddish-brown, their concave sides facing each other.
They are cushioned in fat, with only the tops of them protected by the
rib cage. Perched on top of each kidney is an adrenal gland, which
produces many hormones vital to life. The right kidney is a little
lower than the left because it must squeeze under the liver, a large
organ that occupies a large section of the upper right abdominal
cavity.

In the concave section of the kidney is a depression containing blood
vessels, nerves and the ureter, a small tube that carries urine away
from the organ and down to the bladder. The blood-filtering units of
the kidney are microscopic tubes called nephrons.

The leading causes of end-stage renal (kidney) disease are diabetes
and high blood pressure. These two conditions take a toll on blood
vessels, and the kidneys are rich with blood vessels. Managing these
diseases can go a long way toward preventing kidney failure and the
need for dialysis. (See [3]"Diabetes Demands a Triad of Treatments" in
the May-June 1997 FDA Consumer.)

If your kidneys are normal, they don't need special care. A healthy,
balanced diet and enough water to quench thirst are adequate to keep
kidneys working fine. Fad diets, such as those very high in protein,
however, can hurt your kidneys. Drinking very little water, or an
overabundance of water (more than 8 quarts a day), may also damage
these organs.

Other than illnesses, the real kidney killers are drugs--they must
pass through the kidney to be filtered out of the bloodstream. Some
antibiotics, anesthesia medications, and antipsychotic drugs may
damage kidneys. Even over-the-counter painkillers, if taken in large
doses, may lead to kidney failure.

Common household chemicals can also hurt your kidneys. Chemical
solvents, wood alcohol, toluene, carbon tetrachloride (a cleaning
fluid), and ethylene glycol (antifreeze) can damage kidneys if
ingested or inhaled. Be very careful handling any chemical and use it
according to directions.

--R.D.W.

FDA Consumer magazine (January-February 1998)
_________________________________________________________________

[4]FDA Home Page [5]Table of Contents

References

1. http://www.fda.gov/fdahomepage.html
2. http://www.fda.gov/fdac/198_toc.html
3. http://www.fda.gov/fdac/features/1997/497_dia.html
4. http://www.fda.gov/fdahomepage.html
5. http://www.fda.gov/fdac/198_toc.html