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FDA clears Centurion portable dialysis water treatment system with heat disinfection
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The Centurion portable dialysis water treatment system from AmeriWater has been approved for marketing by the U.S. Food and Drug Administration for use in medical facilities or at home. The integrated heat disinfection design of the Centurion disinfects the entire unit in a single step – including the membrane and the delivery lines up to the inlet of the dialysis machine, according to AmeriWater.
The Centurion has a flow rate of 1500 milliliters per minute based on a 50°F supply, according to information provided by AmeriWater. The unit has a built-in UF device to enhance the microbiological quality to UPW levels ie <0.03 Endotoxin units and <0.1 cfu/ml bacteria, making the water suitable not just for hemodialysis but for hemodiafiltration. The Centurion is also equipped touch screen display, optional data logging, backflow protection of the incoming mains water supply, an internal leak detection system, a and “whisper mode” for nocturnal dialysis.
“We’re very excited to introduce this innovative unit which complements our complete line of dialysis water treatment systems for home use, and medical facilities.” said AmeriWater CEO Diane Dolan.