Dialysis Monitoring
Renal dialysis facilities operate under the American National Standards for Hemodialysis Systems guidelines, which are developed by the Association for the Advancement of Medical Instrumentation (AAMI). The general requirements state that water used to make up dialysis solutions, sanitant and rinse for multiple use dialyzers as well as dialysis solutions (such as dialysate), shall be monitored for bacteria at least once per month.
In June 2001, AAMI revised the bacteriology guidelines for water used to prepare dialysate (also known as dialysis water). The thresholds remain the same for both water used in the preparation of dialysate and dialysis water, which should not contain total viable microbial counts ≥200 cfu/mL and ≥2000 cfu/mL, respectively.1,2 The revised guidelines now exclude the calibrated loop method and the use of blood and chocolate agars. AAMI recommends utilizing the following methods to obtain total viable counts:
- Spread plate method performed with Tryptic Soy Agar (TSA) or equivalent nutrient media
- Membrane filtration method performed with Tryptic Soy Agar or equivalent nutrient media, including commercial water testing devices1,2 such as Millipore Samplers.
Monitoring Bacterial Quality by Allowing Trend Analysis
Samplers have not only been used to analyze water in the pharmaceutical, food, and beverage industries for over 15 years, but have also been recommended for the testing of dialysis water and dialysate over the last 10 years.6 Samplers provide a means of monitoring the bacterial quality of dialysis water purification and dialysate distribution systems by allowing trend analysis of the resulting counts. Millipore Samplers offer a quick, simple and accurate way to assess the bacterial quality of dialysis water and dialysate.Millipore’s HPC and Total Count Samplers are self-contained, ready-to-use devices, individually packaged and sterilized. The HPC Sampler uses Heterotrophic Plate Count Agar as described in Standard Methods for the Examination of Water and Wastewater.3 It also is an American Society for Testing and Materials (ASTM) recognized method for the detection of heterotrophic bacteria in water.5. The Total Count Sampler uses Plate Count Aga, which can also be found in Standard Methods.4
Millipore Samplers Offer a Convenient Alternative to the Standard Methods MF Method for Routine Monitoring
Traditional microbiological tests are not suitable for the dialysis center because they often require media preparation and microbiological laboratory equipment not typically found in such a facility. Each Sampler consists of a plastic paddle, an air vent on the back of the paddle, a Millipore membrane filter with a 0.45 µm pore size, which is in contact with a pad containing nutrient medium, and a plastic case for sampling and incubating.This configuration allows 1 mL of sample to be drawn through the filter by capillary action. The sample liquid then re-hydrates the nutrient medium contained in the absorbent pad and the microorganisms in the sample adsorb to the filter surface. During incubation, nutrients from the medium diffuse through the filter to promote the growth of the microorganisms into a visible colony. The filter is marked with a grid to aid in counting the colonies on the surface.
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1Association for the Advancement of Medical Instrumentation.Hemodialysis Systems. ANSI/AAMI RD5-1992. Arlington, VA: AAMI, 1993 American National Standard
2Association for the Advancement of Medical Instrumentation. Water treatment equipment for hemodialysis applications. ANSI/AAMI RD62:2001 (ANSI approval pending). Arlington,VA:AAMI, 2001 American National Standard
3American Public Health Association, American Water Works Association and Water Environment Federation, 9215 Heterotrophic Plate Count, Standard Methods for the Examination of Water and Wastewater 20 th Edition,1998. Note: m-HPC Samplers contains: Peptone,20 g/L; Gelatin,25 g/L; Glycerol, 10 mL/L and no Agar.
4American Public Health Association, American Water Works Association and Water Environment Federation, 9215 Heterotrophic Plate Count, Standard Methods for the Examination of Water and Wastewater 20 th Edition,1998. Note:Total Count Samplers contain:Tryptone, 5 g/L; Yeast Extract, 2.5 g/L; Glucose, 1 g/L and no Agar (plate count medium).
5American Society for Testing and Materials (ASTM), Standard Test Method for On-Site Screening of Heterotrophic Bacteria in Water, Designation F 488-95, Annual Book of ASTM Standards Vol.11.02 Water (II), ASTM, West Conshohohocken, PA, pp 1013-1017.
6Arduino, M.J., Bland, LA, Aguero, S.M., Carson, L., Ridgeway, M., Favero, M.S., Comparison of Microbiologic Assay Methods for Hemodialysis Fluids, J. Clin. Micro Vol.29, pp 592-594, 1991.
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