Living Day to Day with Kidney Dialysis
Dialysis Under Scrutiny continued...
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.