Biologically Safe Water Filters

AAMI is considering adopting a number of ISO standards.  The main impact on dialysis water quality would be to lower the bacteria limit to 100 CFU/mL instead of 200 CFU/mL (action is still at 50).  Acute units would be the first to be impacted by tighter standards.

At 50 CFU/mL and a dialysate flow of 800mL/min. an average treatment will expose the dialyzer to 9.6 million colonies of bacteria.  At 5 CFU/mL, it drops to 960,000 colonies/treatment.  The patient will not be impacted by all the bacteria but will be exposed to some.

Bacteria can affect the patient in multiple ways.  Since the dialysis provider cannot tell when the bacteria level is high, it’s easier and safer to install an ultrafilter to protect the patient.  Ultrafilters can also be installed on portable RO units to reduce endotoxin levels in acute units.

Many ultrafilters last 3 months or less.  The DSU from Nephros has a 510k for dialysis approval and lasts 6 months.  This filter utilizes quick connects and can be easily changed.