June 15, 2004 - The Centers for Disease Control and Prevent , CDC, has released draft guidelines for public comment on isolation precautions. This document will be for use by infection control staff, healthcare epidemiologists, healthcare administrators, and other persons responsible for developing, implementing, and evaluating infection control programs for healthcare settings across the continuum of care. There are numerous references to hemodialysis and peritoneal dialysis throughout the 198-page report.

"Draft CDC Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2004" - PDF Information page and links from the CDC Division of Healthcare Quality Promotion , DHQP, (link is no longer available)

December 5, 2003 - The Centers for Disease Control and Prevent , CDC, has released the full guidelines for environmental infection control in healthcare facilities. There are references to dialysis water systems, hemodialysis machines, PD environments, and dialysate. Guideline for Environmental Infection Control in Heath-Care Facilities" - Here are the major text portions of the document that pertain to dialysis"

6. Dialysis Water Quality and Dialysate. Rationale for Water Treatment in Hemodialysis, hemofiltration, and hemodiafiltration require special water-treatment processes to prevent adverse patient outcomes of dialysis therapy resulting from improper formulation of dialysate with water containing high levels of certain chemical or biological contaminants.

The Association for the Advancement of Medical Instrumentation , AAMI, has established chemical and microbiologic standards for the water used to prepare dialysate, substitution fluid, or to reprocess hemodialyzers for renal replacement therapy.

The AAMI standards address: a, equipment and processes used to purify water for the preparation of concentrates and dialysate and the reprocessing of dialyzers for multiple use and b, the devices used to store and distribute this water. Future revisions to these standards may include hemofiltration and hemodiafiltration. Water treatment systems used in hemodialysis employ several physical and/or chemical processes either singly or in combination , Figure 6, . These systems may be portable units or large systems that feed several rooms. In the United States, >97% of maintenance hemodialysis facilities use RO alone or in combination with deionization.793 Many acute-care facilities use portable hemodialysis machines with attached portable water treatment systems that use either deionization or RO. These machines were exempted from earlier versions of AAMI recommendations, but given current knowledge about toxic exposures to and inflammatory processes in patients new to dialysis, these machines should now come into compliance with current AAMI recommendations for hemodialysis water and dialysate quality.788, 789 Previous recommendations were based on the assumption that acute-care patients did not experience the same degree of adverse effects from short-term, cumulative exposures to either chemicals or microbiologic agents present in hemodialysis fluids compared with the effects encountered by patients during chronic, maintenance dialysis.788, 789 Additionally, JCAHO is reviewing inpatient practices and record-keeping for dialysis , acute and maintenance, for adherence to AAMI standards and recommended practices.

Neither the water used to prepare dialysate nor the dialysate itself needs to be sterile, but tap water can not be used without additional treatment. Infections caused by rapid-growing NTM , e.g., Mycobacterium chelonae and M. abscessus, present a potential risk to hemodialysis patients , especially those in hemodialyzer reuse programs, if disinfection procedures to inactivate mycobacteria in the water , low-level disinfection, and the hemodialyzers , high-level disinfection, are inadequate.31, 32, 633 Other factors associated with microbial contamination in dialysis systems could involve the water treatment system, the water and dialysate distribution systems, and the type of hemodialyzer.666, 667, 794-799 Understanding the various factors and their influence on contamination levels is the key to preventing high levels of microbial contamination in dialysis therapy.

In several studies, pyrogenic reactions were demonstrated to have been caused by lipopolysaccharide or endotoxin associated with gram-negative bacteria.794, 800-803 Early studies demonstrated that parenteral exposure to endotoxin at a concentration of 1 ng/kg body weight/hour was the threshold dose for producing pyrogenic reactions in humans, and that the relative potencies of endotoxin differ by bacterial species.804, 805 Gram-negative water bacteria , e.g., Pseudomonas spp., have been shown to multiply rapidly in a variety of hospital-associated fluids that can be used as supply water for hemodialysis , e.g., distilled water, deionized water, RO water, and softened water, and in dialysate , a balanced salt solution made with this water, .806 Several studies have demonstrated that the attack rates of pyrogenic reactions are directly associated with the number of bacteria in dialysate.666, 667, 807 These studies provided the rationale for setting the heterotrophic bacteria standards in the first AAMI hemodialysis guideline at <2,000 CFU/mL in dialysate and one log lower , <200 CFU/mL, for the water used to prepare dialysate.668, 788 If the level of bacterial contamination exceeded 200 CFU/mL in water, this level could be amplified in the system and effectively constitute a high inoculum for dialysate at the start of a dialysis treatment.807, 808 Pyrogenic reactions did not appear to occur when the level of contamination was below 2,000 CFU/mL in dialysate unless the source of the endotoxin was exogenous to the dialysis system , i.e., present in the community water supply, . Endotoxins in a community water supply have been linked to the development of pyrogenic reactions among dialysis patients.794

Whether endotoxin actually crosses the dialyzer membrane is controversial. Several investigators have shown

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