Time to End the Aluminum Crises

[obsidianom]

How many of you even knew the following_---THIS IS FROM THE MAYO CLINIC.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substancesFailure to pay attention to proper specimen collection procedures can cause abnormal results due to specimen contamination, which can lead to misinterpretation and misdiagnosis:

-Special evacuated blood collection tubes are required for aluminum testing.(4) These tubes are readily available (Mayo Medical Laboratories Supply T184) and should always be used.

-Most of the common evacuated blood collection devices have rubber stoppers that are comprised of aluminum-silicate. Simple puncture of the rubber stopper for blood collection is sufficient to contaminate the specimen with aluminum. Typically, blood drawn in standard evacuated blood tubes will be contaminated by 20 to 60 ng/mL aluminum

Maybe most everyone (yourself excluded) who kept up with the SAK RECALL thread?

http://ihatedialysis.com/forum/index.php?topic=31141.msg485340#msg485340

http://ihatedialysis.com/forum/index.php?topic=31141.msg485408#msg485408

BD Vacutainer Plus Royal Blue Stopper Plain Blood Collection Tube, product number 368380 (Supply T184 Metal
Free B-D Tube [No Additive]-6 mL) for serum tests EXCEPT ALUMINUM

 Covidien Monoject Royal Blue Stopper No Additive Blood Collection Tube, product number 8881307006 (Supply T713
Metal Free Monoject Serum Tube [Aluminum Only]-7 mL) for ALUMINUM serum tests

The above is from the Mayo labs site.  It clearly shows a SEPERATE special tube for just ALUMINUM . NOT the regular trace elements tube that is used for all other metals etc. I looked at the tube from Spectra that we use for aluminum and it turns out to be the tube for ALL TRACE ELEMENTS . It is a blue topped tube just like the thread says BUT IS THE WRONG BLUE TOPPED TUBE.  There are 2 different blue topped tubes here and Fresenius uses the wrong tube from Spectra. All of us are using the WRONG TUBE>
Spectra uses the B-D TUBE for all tests EXCEPT ALUMINUM instead of the Covidian Monoject Royal Blue  Metal Free tube.

Noahvale I did read the thread. I just found NEW information that EVERYONE missed. There is a lot of misinformation here and I am just ding some REAL research to try to clear this up. Dont forget I and I only found out who really caused the Nxstage aluminum problem . I did a lot of digging to  crack the case .
I am simply doing the same here.
Facts are better then simple angry opinions. I want the truth. I dont want opinion. Something is wrong here but I dont think it is as simple as everyone thinks.

And Peter< I am NOT defending Nxstage . I just think by latching on to aluminum as being the cause of all these symtoms we could miss the boat . Someimes it takes some real digging to find the truth . If we give in to the easiest asnwer  we run the risk of missing the real answer . I just havent been convinced by all I have seen so far that there is STILL an aluminum issue. Yes there WAS one , but it may very well be fixed and there is something else causing symptoms.
Just like Jeff  , I want the BEST for my precious wife. 

"MUST, by K/DOQI guidelines provide dialysate with <5 mcg/liter. That is not happening."   YOUR QUOTE.
WELL ACCORDING TO MY RECENT TEST IT IS HAPPENING. WHAT ELSE DO YOU WANT AS PROOF. I JUST HAD IT TESTED. LESS THEN .005.


http://www.mayomedicallaboratories.com/it-mmfiles/Metals_Analysis_Collection_Transport_final_document.pdf

[noahvale]

*

[obsidianom]

I wont reply publically to the last post which was in a way quite a nasty way to attack me. Just because I am not buying the party line that it is all Nxstage doesnt take away my right here to post and be anonymous like everyone else. I expect better from posters. THIS SHOUDNT BE PERSONNAL.

The following is an example of some of the posts that have been a bit out of line in terms of the truth. I only want the truth .

 Re: Sak Recall
« Reply #28 on: May 16, 2014, 09:22:11 PM »   

--------------------------------------------------------------------------------
"I am quite disappointed in the NxStage letter implying that the levels of aluminum in patients will only be about
10 with the normal level up to 9."

This is what Nxstage ACTUALLY sent out:
"Specifically increases in patient serum aluminum levels averaging 10μg/L have been reported "

Now read both and see what occurred. Nxstage actually said there would be an INCREASE of 10 points per patient . The poster here misinterpreted it to say there would be a LEVEL of 10. That is a twisting of facts to try and make a point.

Now I am trying here desperatly to get to the truth. My wife has high aluminum. I want to know why. If it is Nxstage then fine. But to be only looking at Nxstage could lead to missing the real culprit or culprits. there could be more then one.   Blaming Nxstage now only is like a cop deciding who comminitted a crime based on only a belief and past actions , but not on good investigation of current actions at the time of the crime. By doing that the real criminal may never be found. 
I KNOW MY WELL WATER is an issue. My other patient at aluminum of 27 never used Nxstage . So clearly other factors are in play. She also has a well.
If her aluminum is at 27 you can see just how much comtamination can occur WITHOUT ANY CONTACT FROM NXSTAGE.
I want to help my wife and perhaps other patients. Just yelling about Nxstage will not necessarily do that. The truth is what I need to be able to help her. And I intend to find it. If it turns out to be Nxstage then I will be the first to kick their butts.
Lets not get personal here . You can disagree all you want, just be civil.

[Hemodoc]

Dear Dr. O,

It is quite clear that before NxStage got in bed with the devil, Rockwell, there was NO systemic aluminum issues except in sporadic cases. I have the FMC aluminum study that they sent to all of their FMC providers. Clearly, it is only the patients as a group on the PureFlow that was at risk.

If your tests state <5 mcg/liter, then you are a sporadic case and possibly not tied to the NxStage outbrake.

I have no doubt where my aluminum came from. NxStage. I have no doubt that my aluminum levels went UP after the recall. I have no doubt that my levels went down and my Hb went up when I went back to the bags. No, I don't have precise levels on how high the contamination is at present, but as I stated, a well respected epidemiologist wants to write up a case series because of the data. So, plenty of evidencee that NxStage is STILL poisoning patients with aluminum.

Lastly, we have ALWAYS used the blue top tubes for testing of aluminum. I am a bit surprised your unit apparently did not if this is new information for your unit. That is what I have used for several years of aluminum testing.

[obsidianom]

Peter,
I response to your las tline on the above post, I dug up some research from the Mayo clinic that shows we are ALL doing the aluminum wrong at Fresenius. Yes we get the blue tubes BUT htey are the wrong blue tubes . There are 2 types blue topped tubes.
I have one in my hands now . It was given to me for aluminum test .  It is the B-D Trace Element # 368380.  This is the one Mayo says is NOT to be used for aluminum

See the following from Mayo site I refenced avove.:
 
BD Vacutainer Plus Royal Blue Stopper Plain Blood Collection Tube, product number 368380 (Supply T184 Metal
Free B-D Tube [No Additive]-6 mL) for serum tests EXCEPT ALUMINUM.
 Covidien Monoject Royal Blue Stopper No Additive Blood Collection Tube, product number 8881307006 (Supply T713
Metal Free Monoject Serum Tube [Aluminum Only]-7 mL )  FOR ALUMINUM serum tests


According to Mayo the correct tube is the Covidian Monoject tube # 8881307006
So if you are getting the same tubes we are at Fresenius , that is the WRONG TUBE. Yes it is Blue topped but it is NOT for ALUMINUM. (it is really mainly for lead).
Since I have the tube we use in my hand as I type I know we are using the wrong tube. My guess is ALL FRESENIUS clinics are doing the same.
Mayo claims the wrong blue tube gives a false HIGH READING .
Now with this NEW info please at least give what I am saying some thought. Before we start looking at serum aluminum , we need to at least get the test done correctly.
I think you can beleive the MAYO clinic.

[caregivertech1]

Just FYI, I too thought it may be FMC sampling related back in Feb. after I read the Mayo specs. I went to our major medical center with a physicians order for a serum aluminum test. The blood was drawn in the blue top BD 368380 which was the same FMC uses. Guess where the hospital sent the sample.....the Mayo Clinic. The results were a level of 28. The order of draw is also important but the testing we did with tiger top first vs blue top first in the order of draw both gave an identical AL levels. Just saying.

[caregivertech1]

I was convinced it was a sampling issue as well but the in-center FMC patients all had good AL levels. Only us NxStage users had the high AL. Both were using the same blue top trace metal tubes out of the same case. This really has been frustrating.

[PrimeTimer]

My thoughts and observations: Incompetency seems to be on the rise. Whether it be at the grocery store, pharmacy, auto shop or with the customer service dept of a large company, incompetency and bad attitudes seem to be everywhere. Quality control? What quality control??? In my opinion, this reflects either a lack of training, sign of the times, laziness, stress, no emphasis put on accuracy, corrective measures or sense of responsibility. A lack of work ethics. I once left a good job because my employer did not share my work ethics and expected me to help them cut corners and fudge for them. I said no way and left. Financially, I suffered dearly but I do not regret leaving. Something that our delivery courier said the other week stands out in my mind and it makes me think about NxStage and their ethics.

Due to having limited space, we were not ready for the courier to deliver new SAK's for the new S cycler (that we did not know we were getting). He said no problem, that he could store the SAK's until we were ready to have them delivered, which immediately had me picturing the SAK's being stored inside a hot warehouse during a 100 degree heatwave. Again, he said no problem because in order to contract with NxStage, he said his warehouse had to be equipped with a temp-controlled area and added that besides that, he did not want to take the chance of killing people all because he did not store dialysis fluid in a temp-controlled area. That's when I thought about NxStage...

When I think of NxStage, I think about how much work, research and cost must have gone into their medical devices (cyclers, bags, saks, paks, cartridges, pureflow machines, etc...). Makes me wonder why they even went into the dialysis business. Obviously they want to make a profit and be able to offer customers the most leading-edge technology and services. And to do that, they have got to be competitive, accurate and afford to employ the best engineers, tech-support 24/7 to help us survive a situation during treatment and a professional customer service dept. Given Rockwell's history, I do not understand why they chose to do business with them and that troubles me. Not knowing what my husband's "baseline" aluminum level pre-dialysis troubles me. The fact that his center did not want to perform the test troubles me. Everything troubles me. But...given NxStage's history and their own record, I think it speaks for itself. Overall, they seem to share the same work ethics as I expect from myself. In light of this recent aluminum contamination issue, I hope they review their quality control procedures and that of any other entities they do business with and ask themselves if these other entities share the same ethics.

By the way, we are still waiting on the results of my husband's blood aluminum level. Since his center would not test him, his Neph wrote him a prescription to have it tested and we used a lab (not Spectra) independent of his center. They drew two separate blue-topped vials that were different in appearance from each other. If his results reveal a toxic level then of course, we will have more worries and decisions to make. Keeping our fingers crossed...

[Hemodoc]

I was convinced it was a sampling issue as well but the in-center FMC patients all had good AL levels. Only us NxStage users had the high AL. Both were using the same blue top trace metal tubes out of the same case. This really has been frustrating.

Yes, that is exactly the reason why FMC forced the NxStage recall in the first place. It is ONLY the PureFlow NxStage patients, not those on the bags.

[obsidianom]

I have been thinking about this whole mess. I am actually slightly considering going back to the Fresenius Home system if things dont improve. Has anyone else considered this? I hate to do it but I have to do whats best for my wife.

In the meantime I have a plan for us . I am switching to bottled water and Zero water only now. In 2 weeks we will retest the aluminum. If it is still above 20 then I plan to do a week of hanging bags next month just before the next aluminum test . We have to use them up anyway as they are almost out of date and need to be replaced. That will give me a chance to see if the hanging bags really are better. This is the most scientific way I can go about this. Try one variable change at a time and test.

[Simon Dog]

Was 13 pre-recall; am 10 3 months post-recall.  The FMC center I used is testing all SAK users 3 months after getting rid of the problem saks, and routinely does it every January.

[obsidianom]

Was 13 pre-recall; am 10 3 months post-recall.  The FMC center I used is testing all SAK users 3 months after getting rid of the problem saks, and routinely does it every January.

Well since you are using Pureflow this is another example of it being ok. It appears you have no aluminum issue.  I would be very happy with 10.

[obsidianom]

Check out my new thread under general Discussion on Drinking Water.  Very interesting tests.

[Maggie and Jeff]

I spoke with the nurse about the AAMI on the hanging bags.  The only thing without the less than < symbol was the zinc.

[Angiepkd]

To me, there is absolutely no doubt that the contaminated SAK's caused my high aluminum levels.  I was tested pre-D and my levels were normal.  I have had kidney disease with declining function since I was 17 years old (nearly 30 years).  My water was tested and was found to have acceptable levels of Al.  All of my Al labs were drawn with a special lab tube without the seal that could skew the Al numbers.  As my blood Al levels increased, my Hg decreased and vice versa.  I agree that other factors, such as contaminated well water could make the Al numbers higher, but that doesn't change the fact that the SAKs added to that amount. There seem to be more than enough people whose Al numbers climbed using NxStage SAKs to prove a correlation between the SAKs and elevated Al.  I am not seeking any monetary compensation from NxStage.  I want them to acknowledge and correct the problem, and I don't have complete confidence that they have done that.  I am blessed enough to be free from D for now.  I am thankful that I don't have to continue to use a product that I feel could be unsafe.  No one should have to do that. 

[Hemodoc]

So true Angie. There is no doubt that they still have levels of aluminum that is too high. As long as the bags work, we will work with NxStage for now.

It is not likely anyone will obtain compensation from NxStage given the difficulty in proving "harm" in a legal sense. I have no doubt that they have harmed us, but the lawyers are looking at it in a different light.

It will need to be a political and cultural movement. Even that shall be difficult to accomplish but we shall push on.

[obsidianom]

WE are switching to bags this weekend. I have an order of 75 boxes coming for all the bags for a month. Not happy about it but worht trying as my wifes aluminum is still up. Its weird because everyone else in our area has aluminum dropping back to normal on Nxstage with the Pureflow. For some reason my wife is still way up. So I decided to try the bags for a month and see what happens.
I was able to hang 5 bags on the holder and 1 Bag on the warmer .   It is cumbersome but works.
We will see.

[obsidianom]

Interesting article on in center aluminum levels in another country. Notice the range in dialysis patients vs. non renal patients. The levels are much higher in the dialysis patients . As high as  49.2.    Now my wife is at 41 which is within their range . So it will be interesting to see if her aluminum drops on the bags .
It may be also that we should expect higher aluminum levels in all dialysis patients simply because they cant excrete it and dialysis is not able to remove all of it.  The whole issue is a concern and should be studied much more . 

Aluminium in chronic renal replacement therapy patients undergoing haemodialysis in two renal units in Bogotá].

 [Article in Spanish]

Cárdenas O1, Segura O, Puentes W, Sanabria M, Nava G, Torrenegra R.

OBJECTIVE:

Determining aluminium concentrations in the serum of patients undergoing chronic renal replacement therapy with haemodialysis and concentration in distribution network water and dialysis in two renal units in Bogotá.

MATERIAL AND METHODS:

This was a descriptive study of 63 haemodialysed patients and 20 healthy subjects. Aluminium concentration was determined in water and serum using graphite furnace atomic absorption spectrometry with deuterium lamp background corrector.

RESULTS:

Average aluminium concentration was 26.5 µg/L in patients (ranging from 11.2 to 49.2 µg/L; 8.03 standard deviation) and 8.05 µg/L in healthy individuals (ranging from undetectable to 17.2 µg/L; 4.31 standard deviation). Aluminium concentration in dialysis water and distribution network water was below 2 µg/L and 200 µg/L, respectively.

CONCLUSIONS:

Aluminium concentration in water and serum in this study was below international standard values, thereby indicating appropriate treatment. Additionally, aluminium concentration in pre-HD and post-HD sera was below that reported previously. Aluminium hydroxide uptake increases aluminium concentration in serum. Personal situation regarding age, gender, civil and work status were not risk factors determining aluminium concentrations in serum.


PMID: 21340131 [PubMed - indexed for MEDLINE] Free full text

[Hemodoc]

Actually, there are some very well done studies, most not in the US for some unknown reason, sigh. Here is one that is VERY important. It shows that dialysate with more than 3 mcg/liter results in accumulation of aluminum in the tissues. This article written in 1998 has largely been ignored and certainly ignored by the K/DOQI guideline committees dealing with these issues.

http://ndt.oxfordjournals.org/content/13/suppl_3/78.full.pdf

When the dialysate has 3 mcg/liter or less, then aluminum levels fall in dialysis patients. The interesting aspect of this article is how dialysate levels correlated with serum levels in the patient

Once again, there is no safe level of aluminum for dialysis patients.
 

[PrimeTimer]

WE are switching to bags this weekend. I have an order of 75 boxes coming for all the bags for a month. Not happy about it but worht trying as my wifes aluminum is still up. Its weird because everyone else in our area has aluminum dropping back to normal on Nxstage with the Pureflow. For some reason my wife is still way up. So I decided to try the bags for a month and see what happens.
I was able to hang 5 bags on the holder and 1 Bag on the warmer .   It is cumbersome but works.
We will see.

Hope you guys see her aluminum level come down. Hanging bags are no fun but no matter the modality, I don't think any part of dialysis is easy on anyone. But doing the right thing is. Good luck, please keep us posted.

[PrimeTimer]

Actually, there are some very well done studies, most not in the US for some unknown reason, sigh. Here is one that is VERY important. It shows that dialysate with more than 3 mcg/liter results in accumulation of aluminum in the tissues. This article written in 1998 has largely been ignored and certainly ignored by the K/DOQI guideline committees dealing with these issues.

http://ndt.oxfordjournals.org/content/13/suppl_3/78.full.pdf

When the dialysate has 3 mcg/liter or less, then aluminum levels fall in dialysis patients. The interesting aspect of this article is how dialysate levels correlated with serum levels in the patient

Once again, there is no safe level of aluminum for dialysis patients.

Hemodoc: Thanks for providing that report. And I agree, there is no safe level of aluminum. Seems it can build up quicker in some patients, slower for others but either way, it does pose a threat and it's scary to think about. 

[obsidianom]

On another note as I watch the bags hanging today, the cleaning kit worked wonders. I ran it through as directed yesterday(quite easy) and today the drain line no longer smells bad.  Thats a nice surprise. They should have done this sooner. Its going to be every 3 months now.

[Hemodoc]

On another note as I watch the bags hanging today, the cleaning kit worked wonders. I ran it through as directed yesterday(quite easy) and today the drain line no longer smells bad.  Thats a nice surprise. They should have done this sooner. Its going to be every 3 months now.

We use the disposable drain lines. The only thing I drained through the black line was the unused dialysate.

[cassandra]

I probably missed it, but why was the Al in the dialysate again? Couldn't it be filtered out?

[obsidianom]

I probably missed it, but why was the Al in the dialysate again? Couldn't it be filtered out?

It shouldnt have occurred. Suffice it to say it was due to the lactate in the dialysate that is the main ingredient. The company that was subcontracted to produce the lactate for Rockwell had "issues'.   Nxstage had contracted with Rockwell to manufacture the dialysate sak concentrate and Rockwell subcontrcacted to another company to make the lactate base.
  The question now is, where does it stand? Is there aluminum still in the saks? For now we are using bags until we test the aluminum in my wife.