AAMI TIR58

Description / Abstract: 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 document in no way supersedes Standard Methods for the Examination of Water and Wastewater¹ but rather provides common test methods used within the dialysis industry. The reader is advised to reference FDA approval as appropriate or for those tests that 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 ISO documents, CMS regulations as applicable for sampling guidance.