A DRAFT version of Admendment 3 to RD52 on Acute dialysis is now available on the AAMI website. The document is out for public review. Members can download it FREE; $25 for non-members. Here is your chance to get a free copy and to include your 2 cents worth.

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Larry,

Thank you for posting this. As usual, AAMI has gone to far! Requiring backflow prevention and divert to drain systems will make these "portable" systems not so portable! Water pressure is also a very frequent concern, the backflow device is going to reduce available pressure even further!

How does the general population send comments about this document?

Chuck

Interested parties may submit public review comments, in writing, to:
AAMI
1110 N. Glebe Road
Ste 220
Arlington, VA 22201-4795
ATTN: Cliff Bernier
Fax: 703-276-0793; Email cbernier@aami.org

Besides the backflow prevention and divert to drain, what are the other new initiatives? Bacterology? Endo?

The way I read section E.3.6 Reverse Osmosis of the draft, a divert to drain is recommended but is not a requirement.

"Means of preventing product water from reaching the patient could include an
automated divert to drain valve or an immediate response by the operator to an alarm."

quote:

Originally posted by isolated:
Besides the backflow prevention and divert to drain, what are the other new initiatives? Bacterology? Endo?

Ten minute empty bed contact time for carbon is a big one. They do allow dense block carbon filters if the manufacturer of the filters says they provide the equivalent of a 10 minute EBCT.

Cultures and endotoxin testing from each machine monthly.

Thanks Mr. Clean. Are the limits for Bac-T and endo still the same?

061####,

AAMI lets themselves off the hook because they say that they don't require anything, only reccommend, its CMMS that makes the regulations, even though CMMS adopts the AAMI "reccommendations" by reference as regulations. They also play symantics with words such as should and shall. When the surveyors see the "recommendation", you best believe they're going to require it.

This AAMI committee is rather dominated by water industry representatives(no offense Larry)....one has to wonder if some of the reasons behind some of their "reccomendations" is to sell more stuff.

Chuck

This message has been edited. Last edited by: Chuck W,

As far a CMS required divert-to-drain, I think the wording ""Means of preventing product water from reaching the patient could include an
automated divert to drain valve or an immediate response by the operator to an alarm." gives you enough room not to be required to have a divert-to-drain.

If "an immediate response by the operator to an alarm" is not likely, a divert-to-drain is proably a resonable thing to have in the portable RO.

AAMI has rules on who can interpret AAMI standards. Larry, correct me if I am wrong on that.

The endotoxin and bacterial culture standards remain the same with action levels of 1 EU/ml and 50 CFU/ml and limits of 2 EU/ml and 200 CFU/ml respectively.

Chuck, your supposition on AAMI is unfounded. I took the list of the 32 members of the AAMI Renal Disease and Toxification Committee of 2006 and placed the participants in 6 categories. The distribution was
Federal government 3
University 3
Hospital/Clinic Operator 5
Dialysis Machine Mfr. 11
Other industry 5
Water industry 3 (Larry Alexander + 2 from US Filter)
Research institution 1
Unaffiliated 1

Clearly the water equipment manufacturers or equipment distributors were barely represented at all! Renalweb’s yellow pages list 21 companies under Reverse Osmosis – the primary technology. Of these I recognize 11 as bona fide manufacturers. Neither GE nor Mar Cor was represented nor Ameriwater, Better Water, GEM, etc.

This wouldn’t be a problem except that AAMI does very little to solicit intelligent comment. At the least you would think they would ask for review by manufacturing marketplace participants and more users. The vast majority of dialysis professionals fall into the hospital/clinic operator category.

To this end, my next post on this topic will be some of my comments on the amendment. I hope this will promote more discussion and input. Then someone can package it into AAMI comment protocol.

Thank you Larry for keeping us up to date.

Stephen,

I am going by memory (admittedly poor at times) from a presentation at this years NANT Symposium and seem to remember at least a couple from GE/Osmonics and maybe even representation from Minntech. I also spoke to someone at MarCor last week about the potential ramifications of this ammendment and he stated that they (MarCor) have 2 people on the committee and they have not said anything about it yet.

Chuck

Chuck, of course a lot can change in two years. There was a representative from Minntech on the 2006 committee but I didn’t include him as from the water industry. Since 2006 Cantel Medical owns Minntech, Renal Systems, and Marcor Services. Marcor has a contract with GE Osmonics. So all these people represent one manufacturer. Meanwhile, Siemens, the European equivalent of GE, has purchased US Filter.