Copying with Kidney Dialysis

by Food and Drug Administration (FDA)

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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.