AAMI ISO 23500-3:2019 pdf download – Preparation and quality management of fluids for haemodialysis and related therapies

03-12-2022 comment

AAMI ISO 23500-3:2019 pdf download – Preparation and quality management of fluids for haemodialysis and related therapies
4.2.1 General
Dialysis water shall not contain chemicals at concentrations in excess of those listed in Tables 1 and 2, or as required by national legislation or regulations. Table 1 does not include any recommendation in respect of organic carbon, pesticides and other chemicals such as pharmaceutical products and endocrine disruptors that can be present in feed water. It is technically difficult and costly to measure such substances on a routine basis. The effect of their presence on haemodialysis patients is difficult to define and consequences of exposure are probably of a long-term nature. Furthermore, there is an absence of evidence of their widespread presence in water although it is recognized that inadvertent discharges are possible. In view of this, it is not at present possible to define limits for their presence in water used in the preparation of dialysis fluid. Nanofiltration and reverse osmosis are capable of significant rejection of many such compounds. Granular Activated Carbon (GAC) is also highly effective at removing majority of these chemicals. However, as Granular Activated Carbon is widely used in the removal chlorine/chloramine, their use in the removal or organic carbons, pesticides and other chemicals will be dependent upon the size of the carbon filters and/or beds and users shall be aware of appropriate dimensioning since the majority of carbon valences can be already occupied and not available for further removal activity.
5.1 Dialysis water microbiology
Samples shall be collected where a dialysis machine connects to the water distribution loop, and from a sample point in the distal segment of the loop or where such water enters a mixing tank. Samples should be analysed as soon as possible after collection to avoid unpredictable changes in the microbial population. If samples cannot be analysed within 4 h of collection, they should be stored at <10 °C without freezing until ready to transport to the laboratory for analysis. Sample storage for more than 24 h should be avoided, and sample shipping should be in accordance with the laboratory’s instructions. Total viable counts (standard plate counts) shall be obtained using conventional microbiological assay procedures (pour plate, spread plate, membrane filter techniques). Membrane filtration is the preferred method for this test. Other methods may be used, provided that such methods have been appropriately validated and are comparable to the cited methods. The use of the calibrated loop technique is not acceptable.
The culture medium and incubation times selected should be based on the type of fluid to be analysed e.g. standard dialysis fluid, water used in the preparation of standard dialysis fluid, ultrapure dialysis fluid, water used for the preparation of ultrapure dialysis fluid or fluid used for online therapies such as haemodiafiltration. The method selected, should be based on the analysis of the advantages, disadvantages and sensitivity, of each of the methods detailed above. According to the United States Pharmacopeia, “the decision to use longer incubation times”, should be made after balancing the need for timely information and the type of corrective actions required when alert or action level is exceeded with the ability to recover the microorganisms of interest. The advantages gained by incubating for longer times namely recovery of injured microorganisms, slow growers, or more fastidious microorganisms, should be balanced against the need to have a timely investigation and take corrective action, as well as the ability of these microorganisms to detrimentally affect products or processes” [e.g. patient safety].

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