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RD-62 Water for Dialysis

 

The Association for the Advancement of Medical Instrumentation (AAMI) develops standards and Recommended Practices for the dialysis industry. One such standard is RD-62, Water for Hemodialysis. This standard was developed as a replacement for the overall standard for dialysis RD-5. In 2001 AAMI released the first version of RD-62 water for dialysis. Since then this has become a standard followed by many dialysis units and know worldwide. This standard, although addressed to industry, has been adopted by most dialysis facilities.

The most important part of this standard is the level of contamination allowed. A table shows the maximum levels of chemical contaminants that may be present in the dialysis water. These contaminants should be checked at least yearly to assure the proper function of the water system. The level of contamination is based on the allowable contamination in drinking water specified by the EPA. Since the water will come in contact with the dialysis membrane, the level was reduced to one-tenth the EPA level for drinking water.

In addition to chemical contaminants the standard gives the maximum microbial contamination. The levels have been set at 200 CFU/ml with an action limit of 50 CFU/ml. The action limit is the level of contamination at which action should be taken to prevent further degradation of the system. Thus, if testing shows a bacterial count of 50 CFU/ml, action such as disinfection of the system should be performed.

The AAMI water document also requires that the pyrogens be checked in the system. The pyrogenic material levels have been set at 2 EU/ml with an action limit of 1 EU/ml. Both the bacterial and pyrogen levels should be tested monthly.

The RD-62 water standard will shortly be replaced by the newest AAMI recommended practice, RD-52 Water for Hemodialysis.

 


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