Which organization sets the standards for dialysis water quality?

• A. AAMI
• B. FDA
• C. CDC
• D. EPA

Answer: (A)

The main idea is who publishes the standards used to ensure water quality for dialysis. AAMI is the organization that creates and maintains the standards for water used in hemodialysis, including what levels of bacteria, endotoxins, and other contaminants are acceptable, as well as requirements for the water treatment system and ongoing testing. Centers rely on these standards to design, operate, and validate their water treatment processes so the dialysate meets safety guidelines.

FDA, CDC, and EPA have important public health and regulatory roles, but they do not provide the specific dialysis water quality standards that clinics implement day to day. Therefore, the best answer is the organization that specializes in medical device and patient-safety standards for dialysis, AAMI.