Water treatment systems used in dialysis are a critical factor in the overall care received by dialysis patients; they also provide one of the greatest hazards to the patients if they are not functioning properly. Standards and testing methodology defined/developed by the Association for the Advancement of Medical Instrumentation (AAMI) - ANSI/AAMI RD62-2006. Based on these standards, The maximum level of bacteria in water used to prepare dialysis fluid and reprocess hemodialyzers must not exceed the AAMI standard of 200 colony forming units (CFU). The AAMI action level is 50 CFU for bacteria in water used to prepare dialysis fluid. Additionally, the maximum level of endotoxin in water used to prepare dialysis fluid and reprocess hemodialyzers must not exceed the AAMI standards of 2 Endotoxin Units per Milliliter (EU/ml). The action level of endotoxin in water used to prepare dialysis fluid is 1 EU/ml.
To meet these requirements, the water system will typically utilize reverse osmosis to yield high purity water. This water must then be well managed in the system to control particle and microbial content, which in turn can lead to endotoxin risk. Suitable prefiltration is necessary for long term use of the reverse osmosis membrane and in-line microfiltration membranes, which can endure regular and at times aggressive sanitization processes, is critical to maintain patient safety.
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