Ensuring the chemical and microbiological safety of water for hemodialysis or hemodiafiltration: Adapted clinical guidelines of the Ukrainian Association of Nephrologists and Kidney Transplant Specialists

  • M. Kolesnyk Ukrainian Association of Nephrologists and Kidney Transplant Specialists https://orcid.org/0000-0001-6658-3729
  • L. Korol Ukrainian Association of Nephrologists and Kidney Transplant Specialists https://orcid.org/0000-0002-5484-0326
  • E. Krasiuk Ukrainian Association of Nephrologists and Kidney Transplant Specialists
  • V. Novakivskyy Ukrainian Association of Nephrologists and Kidney Transplant Specialists
  • B. Tkachuk Ukrainian Association of Nephrologists and Kidney Transplant Specialists
  • T. Kostynenko Ukrainian Association of Nephrologists and Kidney Transplant Specialists
  • K. Zakon Ukrainian Association of Nephrologists and Kidney Transplant Specialists

Abstract

The purpose of these recommendations is to provide information on regulations, the required scope of action, and forms for recording measures to ensure the chemical and microbiological safety of water used in hemodialysis and hemofiltration.

For patients with chronic kidney disease stage VI, the quality of water is just as vital as treatment itself, since water makes up 98% of the dialysis solution.

Safe and effective hemodialysis can be carried out only after multi-stage water purification, especially given that the centralized water supply in Ukraine does not meet the required standards.

The use of low-quality water is associated with an increased risk of cardiovascular diseases, mortality in dialysis patients, and adverse effects on indicators of oxidative stress and inflammation, as well as decreased immune function and bone integrity.

It is necessary to ensure compliance with ISO standards to guarantee the chemical and microbiological safety of water through continuous monitoring, both internal and external, with the involvement of health care institutions and dialysis centers.

Standard operating procedures (SOPs) regarding technical, chemical, and microbiological monitoring of water quality for HD/HF define the frequency of testing and the responsible personnel for ensuring compliance.

If the water quality does not meet the required parameters for hemodialysis, dialysis is not carried out, and appropriate corrective actions are taken to eliminate the cause.

Downloads

Download data is not yet available.

References

Canaud B, Lucena R, Ward R. Water and dialysis fluid purity for contemporary hemodialysis. Semin Dial.2025;38:12-24. doi: 10.1111/sdi.13174.

ISO 23500-1:2019, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies [Internet]. ISO. International Organization for Standardization. 2019 [cited June 03 2025].

Fresenius Medical CARE 5008 operating instructions manual. Manuals Library. Fresenius Medical Care. [Internet]. 2021. Available from: https://www.manualslib.com/manual/1604268/Fresenius-Medical-Care-5008.html.

Australian drinking Water Guidelines National Health and Medical Research Council. NHMRC. [Internet]. 2011. Available from: https://www.nhmrc.gov.au/about-us/publications/australian-drinking-water-guidelines.

Department for Health and Wellbeing. South Australian Hemodialysis Guidelines: Routine Water Testing and Reverse Osmosis Monitoring. Adelaide: Government of South Australia; 2015.

Bentham R. AS/NZS 5369: The new standard for Reverse Osmosis Water and microbial contaminants [Internet]. Built Water Solutions Pty Ltd; 2022 Mar 8 [updated 2024 Oct 10; cited YYYY Mon DD]. Available from: https://www.builtwatersolutions.com.au/single-post/reverse-osmosis-water-and-microbial-contaminants

Kidney Health Australia. CPG002: Clinical Practice Guideline. Melbourne: Kidney Health Australia; 2024. ISBN: 978-1-76083-415-9.

Kallenbach JZ. Review of Hemodialysis for Nurses and Dialysis Personnel. 10th ed. St. Louis: Mosby; 2020. eBook ISBN: 9780323674416.

Susantitaphong P, Riella C, Jaber BL. Effect of ultrapure dialysate on markers of inflammation, oxidative stress, nutrition and anemia parameters: a meta-analysis Nephrol Dial Transplant. 2013;28(2):438-46. doi: 10.1093/ndt/gfs514.

Zimmermann J, Herrlinger S, Pruy A, Metzger T, Wanner C. Inflammation enhances cardiovascular risk and mortality in hemodialysis patients. Kidney Int. 1999 Feb;55(2):648-58. doi: 10.1046/j.1523-1755.1999.00273.x.

Nou E, Lo J, Grinspoon SK. Inflammation, immune activation, and cardiovascular disease in HIV. AIDS. 2016;30(10):1495-509. doi: 10.1097/QAD.0000000000001109.

Gama-Axelsson T, Heimbürger O, Stenvinkel P, Bárány P, Lindholm B, Qureshi AR. Serum albumin as predictor of nutritional status in patients with ESRDClin J Am Soc Nephrol. 2012;7(9):1446-53. doi: 10.2215/CJN.10251011.

Coulliette AD, Arduino MJ. Hemodialysis and water quality. Semin Dial. 2013;26(4):427-38. doi: 10.1111/sdi.12113.

Sharma S, Bhattacharya A. Drinking Water Contamination and Treatment Techniques. Appl Water Sci. 2017; 7:1043-67. doi: 10.1007/s13201-016-0455-7.

ISO 23500-3:2019. Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies. Geneva: International Organization for Standardization; 2019. Available from: https://www.iso.org/ru/standard/67612.html

ISO 23500-3:2024. Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies. Geneva: International Organization for Standardization; 2024. Available from: https://www.iso.org/standard/84370.html

ISO 23500-5:2024. Preparation and quality management of fluids for haemodialysis and related therapies – Part 5: Quality of dialysis fluid for haemodialysis and related therapies. Geneva: International Organization for Standardization; 2024. Available from: https://www.iso.org/ru/standard/84372.html

ISO 23500-2:2024. Preparation and quality management of fluids for haemodialysis and related therapies – Part 2: Water treatment equipment for haemodialysis applications and related therapies. Geneva: International Organization for Standardization; 2024. Available from: https://www.iso.org/standard/84369.html

ISO 5667-1:2023. Water quality – Sampling – Part 1: Guidance on the design of sampling programmes and sampling techniques. Geneva: International Organization for Standardization; 2023. Available from: https://www.iso.org/standard/84099.html

ISO 5667-3:2018. Water quality – Sampling – Part 3: Preservation and handling of water samples. Geneva: International Organization for Standardization; 2018. Available from: https://www.iso.org/standard/72370.html

ISO 5667-3:2024. Water quality – Sampling – Part 3: Preservation and handling of water samples. Geneva: International Organization for Standardization; 2024. Available from: https://www.iso.org/standard/82273.html

Association for the Advancement of Medical Instrumentation (AAMI). AAMI RD62:2019. Water for hemodialysis and related therapies. Arlington, VA: AAMI; 2019.

WHO Guidelines for Drinking-water Quality, 4th ed., [Internet].2017. Available from: https://www.who.int/publications/i/item/9789241549950.

Winchester JF, Kellum JA, Ronco C, editors. Replacement of renal function by dialysis. 4th ed. Dordrecht: Kluwer Academic Publishers; 1996.

Karkar A, editor. Updates on Hemodialysis [Internet]. IntechOpen; 2023. Available from: http://dx.doi.org/10.5772/intechopen.105316.

Al-Mutaz IS, et al. Water desalination in the Kingdom of Saudi Arabia. Water Research. 2001;35(13):3165-3171.

Borges CR, Lascowski KM, Filho NR, Pelayo JS. Microbiological quality of water and dialysate in a haemodialysis unit in Ponta Grossa-PR, Brazil. J Appl Microbiol. 2007;103(5):1791-7. doi: 10.1111/j.1365-2672.2007.03431.x.

Perez-Garcia R, Rodríguez-Benítez PO. Why and how to monitor bacterial contamination of dialysate? Nephrol Dial Transplant. 2000;15(6):760-4. doi: 10.1093/ndt/15.6.760.

Reverse Osmosis – The Basics. [Internet]. Available from: https://puretecwater.com/reverse-osmosis/what-is-reverse-osmos.

Canaud B, Lucena R, Ward R. Water and dialysis fluid purity for contemporary hemodialysis. Semin Dial. 2025;38(1):12-24. doi: 10.1111/sdi.13174.

European Medicines Agency. Guideline on the quality of water for pharmaceutical use [Internet]. Amsterdam: EMA; 2020 Jul 20 [cited 2025 June 03]. (EMA/CHMP/CVMP/QWP/496873/2018). Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-water-pharmaceutical-use_en.pdf

Centers for Disease Control and Prevention (CDC). Water use in dialysis. Dialysis Safety [Internet]. Atlanta (GA): CDC; 26 Mar 2024 [cited 2025 June 03]. Available from: https://www.cdc.gov/dialysis-safety/hcp/recommendations-resources/water-use-in-dialysis.html

Derzhavni budivelni normy (DBN) V.2.2-10:2022 "Zaklady okhorony zdorovia. Budynky i sporudy” (ostatochna redaktsiia iz pravkamy Zmina №1). [Internet]. Available from: https://dbn.co.ua/load/normativy/dbn/v_2_2_10/1-1-0-1805. [In Ukrainian].


Abstract views: 394
PDF Downloads: 194
Published
2025-09-08
How to Cite
Kolesnyk, M., Korol, L., Krasiuk, E., Novakivskyy, V., Tkachuk, B., Kostynenko, T., & Zakon, K. (2025). Ensuring the chemical and microbiological safety of water for hemodialysis or hemodiafiltration: Adapted clinical guidelines of the Ukrainian Association of Nephrologists and Kidney Transplant Specialists. Ukrainian Journal of Nephrology and Dialysis, (3(87), 3-16. https://doi.org/10.31450/ukrjnd.3(87).2025.01

Section
Problems of Organization and Economics of Kidney Care in Ukraine

Most read articles by the same author(s)