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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