scope:

This Technical Information Report (TIR) identifies common contaminants as well as the test methods commonly used to monitor contaminants in a hemodialysis water treatment system and product water. The TIR will: 1) identify each contaminant with its chemical symbol, as applicable; 2) list maximum allowable levels and action levels as applicable as found in AAMI/ISO Standards and other pertinent references; 3) identify symptoms in hemodialysis patients associated with exposure to a given contaminant; 4) describe adverse effects of a contaminant on hemodialysis equipment and the water treatment system; and 5) identify test(s) used to detect the contaminants while describing the pros and cons of each method, e.g. interference elements.

This TIR does not supersede Standard Methods for the Examination of Water and Wastewater, but rather provides common test methods used within the dialysis industry. The reader is advised to reference The Food and Drug Administration (FDA) approval as appropriate or for those tests that The Centers for Medicare and Medicaid Services (CMS) requires FDA approved methods (i.e., bacteria and endotoxin testing). This document excludes sampling recommendations. Check the manufacturer's instructions for use, test kit or test method instructions, AAMI and/or International Organization for Standardization (ISO) documents, CMS regulations as applicable for sampling guidance.

Applicability and use

This TIR contains information intended to assist end users in making informed decisions regarding which test methodologies are useful to test for the presence of specific contaminants commonly found in water in settings where hemodialysis is delivered, allowable limits and action levels and substances that can interfere with accurate test results.

Disclaimer: Users of any selected test methodology must understand the level of sensitivity, precision, and accuracy and how the test results will correlate to the selected action level/maximum allowable limits.