anyone willing to share their policy on membrane replacement and what validation of the system is needed before patient use? For example, do you not treat patients or run on DI until culture and AAMI results are received? We are talking about a direct feed CWP.
A dialysis facility’s Medical Director has the ultimate responsibility for ensuring the quality of dialysis water. That is right out of AAMI standards. ANSI/AAMI/ISO 23500-1:2019 page 22.
AAMI makes a broad statement about performing a chemical analysis after making any change that may affect water quality, with the exception of replacing components that are routinely replaced, such as filters. As long as the percent rejection of the new membranes is as expected, our medical director is OK with using the RO while waiting for the results of the chemical analysis. Some people like to send in a sample of the feed water at this time, so they can see exactly how well their RO is performing. We also draw samples for culture and for endotoxin testing.
The current CMS standards recommend going to weekly culture and endotoxin testing for one month after replacing RO membranes. Tag V213. Using an RO with new membranes before the culture and endotoxin results come back would be up to the medical director. Our medical director does not have a problem with this.
As long as your water treatment system was validated when it was first installed, I don't see why it would have to go through another validation process. You only replaced the RO membranes. You didn't change anything in the design of the system. The performance of the new membranes is being monitored whenever the RO is running.
Be sure you flush the new membranes for at least as long as the manufacturer recommends and follow their instructions for the first disinfection. I know of a tech who wiped out two full sets of membranes by not rinsing them long enough and then hitting them with the maximum level of disinfectant allowed.
Much of this is in AAMI's 2022 Complete Dialysis Collection, but it is sometimes difficult to find exactly what you are looking for.
replace them then 4 set of culture and endotoxins. we ran the ro (when no pt's were on, did di for pt days) and made adjustments (replaced both membranes aquaboss) until it was all in spec. used to be 3 draws (we only do 3 draws on new dialysis machines or ones that were oos for more than a month) but our medical director said the new requirements were 4 on replacing membrane so gotta do what he says and if he wants more restrictive requirements we have to do it...you can go more strict, just not less strict than manufacturers recommendations, and if the MD says to go more strict you gotta do it