Living day-to-day with kidney dialysis: quality improvements continue for devices and clinics

Living day-to-day with kidney dialysis: quality improvements continue for devices and clinics – includes related article on kidney care

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

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

ill-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

accompanying article, “Take Care of Your

Kidneys”).

Says Eknoyan, “Prevention is going to

be a big part of the answer.”

RELATED ARTICLE: Take Care of Your Kidneys

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

“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.

[ILLUSTRATION OMITTED]

Rebecca D. Williams is a writer in Oak

Ridge, Tenn.

COPYRIGHT 1998 U.S. Government Printing Office

COPYRIGHT 2004 Gale Group