Endotoxin quality of ultrapure dialysis fluid for online hemodiafiltration in several hemodialysis centers

Abstract

Globally, the nephrology community is seeing a rise in the use of high-flux membranes and ultrapure water in hemodialysis (HD) machines. However, data on HD water quality could be more extensive in low- and middle-income countries. The Ministry of Health in Iraq issued a rule requiring a gradual modification in the HD water treatment system to adopt ultrapure water in all dialysis centers. The current study aimed to monitor the endotoxin of ultrapure dialysis fluid at several centers in Iraq and the clinical benefits of its use. This work evaluated the quality of ultrapure water used for dialysis in twenty-one dialysis centers within various Iraqi province hospitals. The samples were collected for 4 months from January to April 2022. Endotoxin tests in ultrapure dialysis fluid were measured by Gel Clot assay. Results showed an unacceptable difference in the ultrapure dialysis fluid's quality compared to the international standard (ANSI/AAMI/ISO-23500). Endotoxin levels in 33% of ultrapure dialysis fluid above 0.03 EU/ml, exceeding recommended international standards. The findings highlight the importance of assessing water quality in medical facilities to ensure patient safety and encourage sanitary monitoring of this procedure as a healthcare promoter. Keywords: Ultrapure water; Hemodiafiltration; Dialysis fluid; Endotoxin; Public Health Reform.