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AAMI
Oct 12, 2022 19:27:58 GMT
Post by groom on Oct 12, 2022 19:27:58 GMT
What are the AAMI standards now for hemodialysis? I have looked online and found different answers. I'm sure it's changed over the past years.
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AAMI
Oct 12, 2022 20:06:52 GMT
Post by Chuck Weddle on Oct 12, 2022 20:06:52 GMT
The most recent document is 23500 and is published in about 6 parts.
RD52 and RD62 remain the documents that are enforced by CMS
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AAMI
Oct 12, 2022 23:38:08 GMT
Post by Guest74 on Oct 12, 2022 23:38:08 GMT
In doing an internet search, I can see the confusion. AAMI standards have become more strict, but the old standards never get taken down. Damn Google. Microbiological Level Standard Dialysis Fluid - Colony Forming Units < 100 CFU/mL, Endotoxin Units < 0.50 EU/mL Standard Dialysis Fluid Action Level ≥ 50 CFU/mL, ≥0.25 EU/mL Microbiological Level Water Standard - Colony Forming Units < 100 CFU/mL, Endotoxin Units < 0.25 EU/mL Water Action Level - ≥ 50 CFU/mL, ≥0.125 EU/mL Dialysis fluid is dialysate. CMS still follows the old standards from 2008. In order for CMS to make a change, they have to post the proposed change in the Federal Register and allow time for comments. If you decide to adopt the new AAMI standards as your policy, you must follow them. CMS can ding for not following your own policies and procedures. dialysiswatersolution.com/regulations-and-guidelines/ansiaami/ |
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AAMI
Oct 13, 2022 9:43:18 GMT
Post by Chuck Weddle on Oct 13, 2022 9:43:18 GMT
In doing an internet search, I can see the confusion. AAMI standards have become more strict, but the old standards never get taken down. Damn Google. Microbiological Level Standard Dialysis Fluid - Colony Forming Units < 100 CFU/mL, Endotoxin Units < 0.50 EU/mL Standard Dialysis Fluid Action Level ≥ 50 CFU/mL, ≥0.25 EU/mL Microbiological Level Water Standard - Colony Forming Units < 100 CFU/mL, Endotoxin Units < 0.25 EU/mL Water Action Level - ≥ 50 CFU/mL, ≥0.125 EU/mL Dialysis fluid is dialysate. CMS still follows the old standards from 2008. In order for CMS to make a change, they have to post the proposed change in the Federal Register and allow time for comments. If you decide to adopt the new AAMI standards as your policy, you must follow them. CMS can ding for not following your own policies and procedures. dialysiswatersolution.com/regulations-and-guidelines/ansiaami/ Just to clear up any confusion. These levels are from 23500 and are not enforceable by CMS unless they are incorporated into your company policy. The 23500 standard states: 4.1.2 Microbiological requirements for standard dialysis fluid
Standard dialysis fluid shall contain a total viable microbial count of less than 100 CFU/ml (when tested in accordance with Clause 5) and an endotoxin concentration of less than 0,5 EU/ml (when tested in accordance with Clause 5). Action levels for the total viable microbial count and endotoxin concentration in dialysis fluid should also be set based on knowledge of the microbial dynamics of the system. Typically, the action levels are set at 50% of the maximum allowable levels for total microbial count and endotoxin; other levels can be set. The RD52:2004 ( Enforced by CMS) states: 4.1.2 Bacteriology of water
Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for reuse, shall contain a total viable microbial count lower than 200 CFU/mL and an endotoxin concentration lower than 2 EU/mL. The action level for the total viable microbial count in the product water shall be 50 CFU/mL, and the action level for the endotoxin concentration shall be 1 EU/mL. If those action levels are observed in the product water, corrective measures shall promptly be taken to reduce the levels. The manufacturer or supplier of a complete water treatment and distribution system shall demonstrate that the complete water treatment, storage, and distribution system is capable of meeting the requirements of RD52 at the time of installation. |
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AAMI
Oct 14, 2022 15:15:09 GMT
Post by groom on Oct 14, 2022 15:15:09 GMT
So I'm a little confused. So you're saying the AAMI standards that CMS enforces and which we (Fresenius) should be using is, 4.1.2 Bacteriology of water? I'm just trying to get this all straight for my upcoming BONENT chbt certification
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AAMI
Oct 14, 2022 15:22:07 GMT
Post by groom on Oct 14, 2022 15:22:07 GMT
So I'm a little confused. So you're saying the AAMI standards that CMS enforces and which we (Fresenius) should be using is, 4.1.2 Bacteriology of water? I'm just trying to get this all straight for my upcoming BONENT chbt certification Which I know the Bonent is not company oriented, so it won't matter what Fresenius uses. I guess what my question is, is what would be the correct answer on the CHBT certification test? |
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AAMI
Oct 14, 2022 15:28:15 GMT
Post by Chuck Weddle on Oct 14, 2022 15:28:15 GMT
So I'm a little confused. So you're saying the AAMI standards that CMS enforces and which we (Fresenius) should be using is, 4.1.2 Bacteriology of water? I'm just trying to get this all straight for my upcoming BONENT chbt certification It's probably best to be familiar with both standards. All of the questions are multiple choice so you should be able to determine which answer is correct. That said and just my opinion..... the last I heard their CHT exam is way out of date so I doubt the CHBT is any more current. I would concentrate more on RD52 and RD62. |
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AAMI
Oct 14, 2022 17:04:01 GMT
Post by dave74 on Oct 14, 2022 17:04:01 GMT
I have to agree with Chuck. When I worked for a DaVita affiliate, I couldn't order the AAMI standards because the cost is high and because DaVita's policies and procedures are based on AAMI standards.
How could you expect someone to know AAMI standards if they don't have access to the book?
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AAMI
Oct 15, 2022 2:18:29 GMT
via mobile
Post by bimitiri on Oct 15, 2022 2:18:29 GMT
AAMI now inline with ISO 23500.
I currently based in Australia and we used to follow both AAMI and Iso 11663 standards depending on the clients.
in 2019, iso 11663 became ISO 23500-5 . Thus there now only ISO 23500
For reverse osmosis machine,
Bacteria count (CFU)< 100
Endotoxin (LAL ) < 0.25
For dialysis machine without endotoxin/ultrapure filter
Bacteria count (CFU)< 100
Endotoxin (LAL ) < 0.25
For dialysis machine ( HD treatment only) with endotoxin/ ultrapure filter
Bacteria count (CFU)< 0.1
Endotoxin (LAL ) < 0.03
For dialysis machine ( HDF treatment) with two endotoxin / ultrapure filters ~ to allow online substitute fluid
Bacteria count (CFU)< 0.1
Endotoxin (LAL ) < 0.01
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AAMI
Oct 20, 2022 20:51:18 GMT
Post by CafeRacer68 on Oct 20, 2022 20:51:18 GMT
just going to bum off this thread can someone send me a updated Water testing methodologies?
MODERATORS NOTE: The sharing of copyrighted materials is not allowed.
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AAMI
Oct 20, 2022 20:55:54 GMT
Post by Chuck Weddle on Oct 20, 2022 20:55:54 GMT
just going to bum off this thread can someone send me a updated Water testing methodologies? I have no idea what you're asking for. |
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AAMI
Oct 20, 2022 22:03:38 GMT
Post by dave74 on Oct 20, 2022 22:03:38 GMT
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AAMI
Oct 20, 2022 23:13:01 GMT
Post by dave74 on Oct 20, 2022 23:13:01 GMT
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AAMI
Oct 21, 2022 9:35:30 GMT
Post by Chuck Weddle on Oct 21, 2022 9:35:30 GMT
Thanks, Dave!
I (my company) bought 23500 August of last year and I honestly have only begun to digest it. I never even noticed the TIR documents. Even though purchased in 2021, my copy of TIR58 is from 2014. I feel a little ripped off!
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AAMI
Oct 21, 2022 17:51:53 GMT
Post by CafeRacer68 on Oct 21, 2022 17:51:53 GMT
Yes that's what I was asking for, but at $240 I might as well buy the full collection. just wish it was an official book instead of PDF
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