Ever since 1976, water treatment systems for dialysis have been classified as Class II medical devices by the FDA. High flux dialyzers and hemodialysis machines fall into this same category. Since then many documents have been published including one back in 1989 from the FDA titled, A Manual on Water Treatment for Hemodialysis. Per the FDA, water treatment equipment, devices, and systems used for hemodialysis and related therapies must comply with ANSI/AAMI Standards.
Manufacturers and suppliers that wish to promote and sell equipment as medical devices must obtain clearance from the FDA prior to going to market. This Premarket Notification process and subsequent clearance is known as a 510(k). A formal and detailed submittal process is required. Those requirements are published in the Code of Federal Regulations (CFR) title 21.
Equipment must be manufactured under strict guidelines and in accordance with Quality System regulations. The FDA can and does inspect manufacturer’s facilities, looking over complaints, documented procedures, training logs, and other areas to ensure compliance. The FDA can and will also investigate situations involving patient injury to help determine if there were any malfunctions attributed to a medical device.
The FDA’s intent is to promote patient safety and well-being. In the event it might be required, the device itself or even critical components within these medical devices could be traced and recalled as necessary. A warning letter or even a cease-and-desist notification could be issued if a subsequent audit reveals serve negligence or non-compliant practices. Information about medical device manufacturers is published and can be found on the Internet.
Despite the FDA’s governing body and its establishment of water treatment systems for hemodialysis as a medical device classification, the medical director is still ultimately responsible for the selection and operation of the water treatment system since water is considered part of the patient’s prescription.