GENERAL PURIFICATION CONSIDERATIONS

Chemical and microbial components that can be found in drinking water meeting U.S. Environmental Protection Agency National Primary Drinking Water Regulations (or equivalent) may have the potential to produce significant negative effects in patients undergoing hemodialysis. It is, therefore, necessary to subject the water to further treatment to reduce these components to acceptable levels. The Water for Hemodialysis monograph provides bacterial and chemical tests that are required to ensure patient safety. Additional testing is recommended as follows:

1. Excess levels of aluminum, fluorides, and chlorine may be found seasonally in drinking water as a result of chemicals used in water treatment. These components should be monitored in Water for Hemodialysis being produced in accordance with established standard operating procedures. The maximum acceptable levels of these and other elements and compounds, as proposed by AAMI (Association for the Advancement of Medical Instrumentation) are listed in Table 1. These attributes should be periodically monitored to ensure they are being controlled by the routine testing performed in accordance with the Water for Hemodialysis monograph.

2. A comprehensive validation testing of the system producing Water for Hemodialysis should be performed initially and periodically thereafter to ensure that the water treatment equipment and system sanitization processes are functioning properly.