Living Day to Day with Kidney Dialysis
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.