The AAMI committee met yesterday. There are a few changes coming up. The committee is going to investigate adopting IEC 60601 (they want to adopt 60601-2-16:2008 but this requires adopting the entire 60601). If adopted, RD5 will go away. This mainly applies to the machine manufacturers. I don't know how much impact it will have for the users.

Also, the committee is going to investigate adopting ISO 13958 (to replace RD61), ISO 13959 and 26722 (to replace RD62), ISO 11663 and ISO 23500 which is still being developed (to replace RD52). ISO stands for International Standard Organization; this is what the rest of the world uses instead of AAMI. If adopted, these documents will become AAMI/ANSI/ISO xxxxx. The good news is that these documents are very similar to the AAMI documents....but there are a few differences. I don't have a list yet. The one difference most of you have complained about is the use of TGEA instead of TSA for bacteria, and counting the sample for 5 days instead of 48 hours. And the bacteria limit being 100 cfu/ml instead of 200 (action is still at 50).

If you want to order a copy of these ISO documents, go to http://www.iso.org/iso/home.htm

My personal opinion is that if your machine has an ultrafilter downstream of where bicarb is injected, there should not be a water bacteria criteria and you should not have a problem meeting the dialysate limit. Bottom line...all machines should have an ultrafilter downstream of where the bicarb is injected.

Keep in mind that 50 cfu/ml means there are 50 colonies of bacteria in every ml of water (or 50,000 colonies in every liter). If your dialysate flow is 800 ml/min and you treat a patient for 4 hours, this becomes:

50 x 800 x 60 x 4 = 9,600,000 colonies

The dialyzer will be exposed to 9,600,000 colonies of bacteria per treatment. If your dialysate is 5 cfu/ml, this will expose the dialyzer to 960,000 colonies per treatment. And, even at 0.5 cfu/ml, this will expose the dialyzer to 96,000 colonies per treatment. The patient does not get all of this, but the patient will get some. There is plenty of data documenting the affects bacteria has on patients. You can not tell when the bacteria is high or low just by looking at the water. It is much easier and safer to install an ultrafilter to protect the patient.

AAMI can adopt these documents with exceptions, but there probably will not be many exceptions. AAMI was involved in the development of the ISO documents.

If anyone has any major objections to something in these ISO documents, please feel free to contact AAMI or forward them to me.

It is going to take a few years for all of these changes to happen. And once it is done, CMS will take a few more years to adopt them before you will be required to change anything.....but, changes will probably be coming!

quote:

all machines should have an ultrafilter downstream of where the bicarb is injected.

Please clarify "ultrafilter" downstream of where bicarb is injected. Am I missing something as I was not aware any of our K machines have ultrafilters installed in the hydrolics.

Diasafe filter on Fresenius machine and a diaclear filter on the gambro phoenix. These are ultrafilters.

we have installed diaclears on all of our Phoenix machines and out bacteria counts are close to nothing "0". We also have 6 Fres K machines that were purchased with a mandatory Diasafe filter, never any problem. We have 9 portable RO system in our acute program and it has made managing our bioburden much easier.

What happens when a diasafe filter has a fiber leak in it?

Diasafe filters are changed every 3 months and tested weekly. If there is a fiber leak, it should fail test, and the diasfe takes a minute to change. It is very easy and worth it.

the diasafe may just take a few minutes to replace but then you must bring the machine into condo and run pressure, alarm and the diasafe tests then rinse and disinfect the machine before you can okay it for use. an hour including documentation time. if all goes well