NN&I - May 2010
Facility Management 48 Nephrology News & Issues May 2010www.nephronline.comWater treatment companies and sys -tem integrators have used current puri -fication procedures in the dialysis clin -ic safely and effectively for more than 25 years. These techniques have helped to address potential contamination of water, which is the only common - and the most vital - ingredient in the dialy-sis process. However, emerging tech-nologies and processes are creating higher levels of purity available for this process, which ensure greater safety and care for dialysis patients. Water purity and patient safety By virtue of its sources (surface or ground), all tap water naturally con-tains inorganic and organic contami -nation. It is common knowledge that municipal water suppliers treat water with fluoride, aluminum salts, and free chlorine or chloramines in accordance with Environmental Protection Agency regulations. Despite (or because of) this treatment process, the resulting tap water, which serves as the feed water source for nearly every dialysis facility in the country, is, by definition, contaminated. It is tempting to assume that the water used in hemodialysis is very pure. You may be surprised to learn that current standards are far less than you might expect. For example, the U.S. Food & Drug Administration current -ly requires a higher quality of water for manufacturing toothpaste, suntan lotion, and lipstick than it does to perform dialysis. The companies that produce these products are held to the United States Pharmacopeia (USP) standard for purified water in the pro-duction process. The technology exists, The future of water for dialysis By Chris Fournier Mr. Fournier is the vice president of marketing for Mar Cor Purification, based in Plymouth, Minn. He has been involved in water, filtration, and disinfection products for the dialysis and pharmaceutical markets for over 15 years with companies including Millipore, U.S. Filter, and General Electric. Comparison of water quality standards AAMI/ANSI RD62:2006 USP Monograph Water for Hemodialysis USP WFI WaterMicrobial Specification <200 cfu/ml Microbial Specification <100 cfu/ml Microbial Specification <10 cfu/100ml Microbial Action Level 50 cfu/ml Microbial Action Level 50 cfu/ml Microbial Action Level 5 cfu/ml Endotoxin Specification <2 EU/ml Endotoxin Specification <2 EU/ml Endotoxin Specification <0.25 EU/ml Endotoxin Action Level <1 EU/ml Endotoxin Action Level <1 EU/ml Endotoxin Action Level <0.125 EU/ml Inorganic Specification <20 microsiemen/cm Inorganic Specification <1.3 microsiemen/cm Inorganic Specification <1.3 microsiemen/cm Organic Specification No Requirement Organic Specification <500 ppb C Organic Specification <500 ppb C AAMI/ANSI RD62:2006 EP Monograph Water for Hemodialysis ISO 13959Microbial Specification <200 cfu/ml Microbial Specification <100 cfu/ml Microbial Specification <100 cfu/100ml Microbial Action Level 50 cfu/ml Microbial Action Level 50 cfu/ml Microbial Action Level 50 cfu/ml Endotoxin Specification <2 EU/ml Endotoxin Specification <0.25 EU/ml Endotoxin Specification <0.25 EU/ml Endotoxin Action Level <1 EU/ml Endotoxin Action Level <0.125 EU/ml Endotoxin Action Level <0.125 EU/ml Inorganic Specification <20 microsiemen/cm Inorganic Specification < 5.1 microsiemen/cm, plus limits for nitrate, aluminum, heavy metals Inorganic Specification < 1.3 microsiemen/cm Organic Specification No Requirement Organic Specification <500 ppb C Organic Specification <500 ppb C and is well proven, that reduction in inorganic material is very reliable. The challenge comes from controlling the growth of bacteria.Because water purity standards for hemodialysis in the United States trail other countries' standards, dialysis patients may be exposed to a high-er level of contamination. While this microscopic amount of bacterial or other contamination most likely would not pose a risk to the majority of the population, even small amounts of contamination can have an effect on patient outcomes. Several studies have shown that better patient outcome is a direct result of higher water quality. Focusing on the core problem To address this most critical aspect of hemodialysis, recent advances in bacteria control for water used in the process have emerged and have had Water Facility Manag(NEW).indd 48 4/19/10 10:10:10 AM
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