Dialysis Unit Viable Bacteria/Endotoxin (ET) Measurement Results
RO RO Line Dial. Unit
RO Water Tap Water Membrane (Post- RO Water Tank Exit ETRF) Line Viable Bacteria >100 >279 >73.9 >16 >33 (CFU/ml) Endotoxins 41.5 1.96 2.93 3.18 3.37 (EU/ml) JSDT Recommended n/a Viable Bacteria 0.1cfu/ml : ET 0.001 EU/ml Value JSDT Maximum n/a Viable Bacteria 100cfu/ml : ET 0.05 EU/ml Value
※ Values in red exceed JSDT Maximums Collection Date:2018.08.10
① Tap Water Tank Viable Bacteria: ≧ 100cfu/ml (measurement of exact value impossible) ET: 41.5EU/ml
Indonesia’ s public water
supply is not potable, and its use as a source of water for the RO equipment poses a constant problem of contamination.
For comparison, values of tap
water at St. Mary’ s Hospital are:
Viable Bacteria: 20cfu/ml
ET: 1.4EU/ml ② RO Membrane Exit Viable Bacteria: ≧ 279cfu/ml (measurement of exact value impossible) ET: 1.96EU/ml Tap water is highly contaminated; possible leakage of viable bacteria from RO membrane. However, the removal rate of viable bacteria is 95.3%, meaning the membrane is functioning at a ③ RO Tank decent level. Viable Bacteria: ≧ 73.9cfu/ml (measurement of exact value impossible) ET: 2.93EU/ml Although viable bacteria count in the RO tank is decreasing, ET are on the rise. There is a germicidal lamp attached to the pipeline, so this rise is possibly due to the influence of ETs excreted by the destroyed bacteria. ④ RO Line Post-ETRF Viable Bacteria: ≧ 16cfu/ml (measurement of exact value impossible) ET: 3.18EU/ml
Viable bacteria count
is lower post-ETRF but ET values are high, possibly from leakage due to overburdening.
⑤ Dialysis Unit RO Water Pipe
Viable Bacteria: ≧ 33cfu/ml (measurement of exact value impossible) ET: 3.37EU/ml Contamination is present in the fluid line from the machine room to the dialysis department, possibly due to its excessive length. ET values are likely continually high. Thoughts on Current Measurements of Endotoxins and Viable Bacteria Culture Results During our previous visit to RS Unair in April we conducted a viable bacteria culture test of the RO Tank and RO Line, and during this visit we measured levels of both endotoxins (ET) and viable bacteria in five samples from different locations, ranging from the source tap water to inside the dialysis unit itself. As you saw in the table on the first slide, the viable bacteria count in one location exceeded the maximum limit established by JSDT, and ET levels far exceeded maximum limits in all locations except the tap water itself. Causes of these excessively high values could include the tap water being severely tainted with biological contaminants, exceeding the rejection rate of the RO equipment which then leads to leaks. In addition, both the RO tank and the pipe are thought to suffer from latent contamination, and although the RO line is equipped with ETRF, its rejection capacity is most likely saturated. A germicidal lamp is installed, but when viable bacteria are destroyed by the lamp they release ETs, which explains the relatively high ET values compared to viable bacteria count. Using this biologically contaminated dialysis fluid means that patients are constantly exposed to low levels of inflammatory agents, and depending on original patient condition this could result in a number of symptoms including chills, tremors, fever, etc. It is a concern that this dialysis fluid is negatively affecting patient prognoses. The first concrete control measure is to install ETRFs on every dialysis machine. We would like to discuss moving in this direction with NIPRO. In addition, to control contamination it is necessary to consistently clean/disinfect the RO water pipeline, but this is a large-scale project that warrants special attention around residual disinfectant in the line. This is an issue for the future that should be addressed. Moving forward, we would like to formulate a plan for reducing viable bacteria and endotoxins while offering support on basic management of dialysis fluid purification.