FDA has increased its involvement in regulating the reuse of dialysis equipment. 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. 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.