Reusable dialyzers

[stauffenberg]

The significant point is that even at periods when the technology was such that re-use of dialyzers was known to be toxic for the patients, American dialysis providers persisted in re-using them, since this was yet another way to increase their profit margin within the fixed reimbursement for dialysis treatment allowed them by Medicare.  This willingness to harm patients physically in order to increase profits represents greed bordering on insanity, which in America is called 'free enterprize.'  In other countries, when re-use was known to be toxic, there was no re-use allowed, since dialysis was provided by the government solely to serve the health of the population, not to make profits for anyone.

[boxman55]

I double checked with my clinic and they said absolutely not they would never reuse...Boxman

[plugger]

BigSky,

I read over your article from the AAKP and I'm not seeing much new.  I also have problems with an article when they talk about how a plasma protein from a patient's blood makes the dialyzer less likely to activate the "complement system"; I have to wonder if the author didn't get the memo about the new dialyzers being more biocompatible - also a flaw with that 3rd article I posted.

And correct me if I'm wrong, but doesn't the AAKP get a lot of it's funding from the dialysis companies?

[BigSky]

Not sure funding is going to play into AAKP opinion as they probably are funded by manufactures of supplies also.
   
However with Fresenius  it is in their interest to push new dialyzers over resuse.  They are a huge supplier of product and it will definitely benefit their bottom line by them now pushing the industry to go to new vs reuse.  Yes it seems ideal to go with new but when its a major supplier pushing the objective some huge doubts are raised as to their motive.

Fact is they force,  dialysis clinics to buy their dialyzers  if they need any product from them, such as bicarbonate.

A key sentence of their statement was this.

"We believe there is no disadvantage whatsoever to patients receiving new kidneys utilizing polysulfone membranes."

Those certainly are not the words one would use to tout new dialyzers vs reuse if in fact reuse was no good and new was so much better.

[plugger]

Fresenius spent a lot of years doing reuse and might want to be careful not to knock it too much.  When my daughter was in a Fresenius clinic they used formaldehyde for reuse which concerns me after finding this:


"Handbook of Dialysis" by John T Daugirdas, Peter Gerard Blake, Todd S. Ing
published 2006 page 197

Anti-N antibodies: These can be produced when residual dialyzer formaldehyde levels are high and
have been associated with hemolysis and with early transplant failure; one group has reported their
development even when dialyzers were rinsed to the point that effluent formaldehyde levels were
always below 2-3 ppm (Vanholder et al., 1988).

[plugger]

Joe Paul,

I emailed a couple of friends about your predicament with reuse and hope to get a response to see if anything can be done.

And since I haven't seen anything yet to change my mind about the issue of reuse, I'm going to post a link to the old DialysisEthics site that has numerous studies done on reuse - I'm not seeing anything to invalidate them:
http://www.dialysisethics.org/forum/viewtopic.php?t=488

[BigSky]

Joe Paul,

I emailed a couple of friends about your predicament with reuse and hope to get a response to see if anything can be done.

And since I haven't seen anything yet to change my mind about the issue of reuse, I'm going to post a link to the old DialysisEthics site that has numerous studies done on reuse - I'm not seeing anything to invalidate them:
http://www.dialysisethics.org/forum/viewtopic.php?t=488

They were never valid in the first place.  They are limited in design because they are not prospective, randomized and controlled trials.

A more recent report than those studies, the USRDS Dialysis and Morbidity Study,  has further verified that there is no difference in mortality for reuse and single ­use dialyzers.  The fact that study is more recent would also invalidate those prior studies on the issue of reuse today.



However certain giants of the industry will push for new because it is those sales of new dialyzers to others outside their own units that will turn around and subsidizes the cost of dialyzers to their own units thus making the cost ratio that much more rosy in their marketing of the dialyzers IMO.

Regardless of that I do not see how a unit can dictate if one wanted new or reuse.  I would think the only control they have would be if they had to provide a high end dialyzer or a middle of the road new one.

[plugger]

Just because this study you speak of is more recent doesn't necessarily mean it invalidates everything previous.  Who funded the study, who did the study, their motivation, and their methods have to be considered.  We have two major players here: Fresenius who I will admit probably wants to sell dialyzers and DaVita who has just as strong a motivation not to buy new dialyzers.  Who to believe?  I guess I look for studies I hope are from more independent sources and make sense.  When a study starts talking about biocompatibility and protein layers in a dialyzer, that article or study is pretty quickly off my reliable list since I've heard for years the new dialyzer membranes don't have a problem with biocompatibility - I just get the feeling the author is either trying to put one over or hasn't done proper research.

Anyway, would you be able to provide a link to this USRDS study?  I might be able to find it myself, but would be helpful and faster if you had it.

[plugger]

Not sure funding is going to play into AAKP opinion as they probably are funded by manufactures of supplies also.
   

And these suppliers aren't going to tick off a big customer like DaVita - so the AAKP opinion is still suspect in my book.

[BigSky]

Just because this study you speak of is more recent doesn't necessarily mean it invalidates everything previous.  Who funded the study, who did the study, their motivation, and their methods have to be considered.  We have two major players here: Fresenius who I will admit probably wants to sell dialyzers and DaVita who has just as strong a motivation not to buy new dialyzers.  Who to believe?  I guess I look for studies I hope are from more independent sources and make sense.  When a study starts talking about biocompatibility and protein layers in a dialyzer, that article or study is pretty quickly off my reliable list since I've heard for years the new dialyzer membranes don't have a problem with biocompatibility - I just get the feeling the author is either trying to put one over or hasn't done proper research.

Anyway, would you be able to provide a link to this USRDS study?  I might be able to find it myself, but would be helpful and faster if you had it.

On its own it would not invalidate them.   However they were not valid in the first place.  Reason being they were not scientific in nature.  They were  not prospective, randomized and controlled trials.   

I mean I could make the claim that all people who eat carrots die.  Therefore no one should eat carrots if they do not want to die.  All evidence points to the fact that all people who eat carrots die so does that make the conclusion right?  No, because it was not a controlled trial. 


I certainly agree that at one point there was a problem with resuse.  However it was a variety of factors that led to an increased death rate for those few years and once those problems were recognized and corrected those problems disappeared. 

I haven't bothered to look at recent stats, but as of 1997 most of the world practices reuse.  There were a few that quit reuse but that stemmed from other issues not related to reuse itself.  Such as France where there was a huge scandal with blood banks etc.  I am not sure but even to this day in France reuse is still not banned but however due to those scandals they still haven't gone back into reuse.


Also of note is that Fresenius does not make the claim that new is better than reuse.  They push new but do not come straight out with that claim.  That does speak volumes in todays business world.  If one is trying to change the way the market operates such as going to new use all the time, that would be something they would do if it was true just to change the market share to support them. 

Another case is it has been well over 6 months and Fresenius still hasn't emailed me the stats on their dialyzers.  I would think a company pushing new would be glad to be transparent and release this information.  When one leaves it clouded in mystery it severaly raises questions.  Currently our unit is forced to purchase some Fresenius dialyzers.  However most chose to use Gambro reuse, of which Gambro OPENLY publishes its stats and efficiency of its dialyzers (both new and resue) on the net. 

It is that transparency that tells of a companies belief in their product.  It is very troubling to me that Fresenius or NxStage are lacking in that particular transparency. 

And these suppliers aren't going to tick off a big customer like DaVita - so the AAKP opinion is still suspect in my book.

Yet doesnt Fresenius donate to the AAKP also?

My understanding from AAKP is that they receive funding from all sectors of the Industry.

[plugger]

I imagine Fresenius does give to the AAKP and I imagine they aren't going to go as far as saying reuse is a terrible, horrible thing because someone like me would find a lawyer and slap them with a lawsuit so fast it would make their heads spin - I feel even back in 2000 they knew this was a dangerous practice, yet they still fought me when I stopped them doing reuse on my daughter.

By the way, I still don't see this mysterious "USRDS Dialysis and Morbidity Study" you refer to.  All I'm seeing is that old AAKP article from 2002 and a lot of smoke from you - I'm sure the authors of these studies I'm pointing out would love to hear what they are doing isn't scientific.

So far besides the older studies, I've pointed out a more recent blurb from a book published in 2006.  Here is something even more recent:

"The practice of reusing dialyzers has been widespread in the United States for decades, with single use showing signs of resurgence in recent years. Reprocessing of dialyzers has traditionally been acknowledged to improve blood–membrane biocompatibility and prevent first-use syndromes. These proposed advantages of reuse have been offset by the introduction of more biocompatible membranes and favorable sterilization techniques. Moreover, reuse is associated with increased health hazard from germicide exposure and disposal. Some observational studies have also pointed to an increased mortality risk with dialyzer reuse, and the potential for legal liability is another concern. The desire to save cost is the major driving force behind the continued practice of dialyzer reuse in the United States."
http://cjasn.asnjournals.org/cgi/content/abstract/2/5/1079
August 16, 2007

You have accomplished one thing: I'm now angry again about an issue I let go dormant for years now.  I'm trying to call the one friend who just might be interested in seeing what we can do about helping someone who wants to get off reuse - stay tuned.

[BigSky]

So if Fresenius donates to them doesn't that invalidate your argument that the AAKP is beholden somehow to the likes of Davita?

No one said anything about Fresenius saying reuse was terrible or horrible.

The most telling thing is they are not claiming new is better, they are saying their is no DISADVANTAGE to using new.  That is not the wording one uses if new is so much better as you seem to suggest.

Yet that still doesnt address the issue of them not being transparent to their dialyzer stats.



Mortality risk by hemodialyzer reuse practice and dialyzer membrane characteristics: results from the usrds dialysis morbidity and mortality study.
Port FK, Wolfe RA, Hulbert-Shearon TE, Daugirdas JT, Agodoa LY, Jones C, Orzol SM, Held PJ.

US Renal Data System Coordinating Center, Department of Internal Medicine, University of Michigan, Ann Arbor, USA. portb@umich.edu

Hemodialyzer reuse is commonly practiced in the United States. Recent studies have raised concerns about the mortality risk associated with certain reuse practices. We evaluated adjusted mortality risk during 1- to 2-year follow-up in a representative sample of 12,791 chronic hemodialysis patients treated in 1,394 dialysis facilities from 1994 through 1995. Medical record abstraction provided data on reuse practice, use of bleach, dialyzer membrane, dialysis dose, and patient characteristics and comorbidity. Mortality risk was analyzed by bootstrapped Cox models by (1) no reuse versus reuse, (2) reuse agent, and (3) dialyzer membrane with and without the use of bleach, while considering dialysis and patient factors. The relative risk (RR) for mortality did not differ for patients in reuse versus no-reuse units (RR = 0.96; 95% confidence interval [CI], 0.86 to 1.08; P > 0.50), and similar results were found with different levels of adjustment and subgroups (RR = 1.01 to 1.05; 95% CI, lower bound > 0.90, upper bound < 1.19 each; each P > 0.40). The RR for peracetic acid mixture versus formalin varied significantly by membrane type and use of bleach during reprocessing, achieving borderline significance for synthetic membranes. Among synthetic membranes, mortality was greater with low-flux than high-flux membranes (RR = 1.24; 95% CI, 1.02 to 1.52; P = 0.04) and without than with bleach during reprocessing (RR = 1.24; 95% CI, 1.01 to 1.48; P = 0.04). Among all membranes, mortality was lowest for patients treated with high-flux synthetic membranes (RR = 0.82; 95% CI, 0.72 to 0.93; P = 0.002). Although mortality was not greater in reuse than no-reuse units overall, differences may exist in mortality risk by reuse agent. Use of high-flux synthetic membrane dialyzers was associated with lower mortality risk, particularly when exposed to bleach. Clearance of larger molecules may have a role.


Be angry all you want.  You are pushing studies that were never valid in the first place.  What am I supposed to do, sit back and let you push these invalid studies?  If one wants to reuse or not is entirely up to them IMO and no one else, but trying to justify not to on the grounds of those flawed studies is plain irresponsible IMO.  Those studies are nothing but scare tactics that have no true merit behind them.

[plugger]

BigSky wrote:
"So if Fresenius donates to them doesn't that invalidate your argument that the AAKP is beholden somehow to the likes of Davita?"
Hardly, with Fresenius's past they would want to stay neutral on the issue.  Suppliers aren't going to say anything because they wouldn't want to tick off a big customer like DaVita.  That leaves DaVita - with a financial incentive - to push for reuse.

BigSky wrote:
"No one said anything about Fresenius saying reuse was terrible or horrible."
No, I said it.

BigSky wrote:
"The most telling thing is they are not claiming new is better, they are saying their is no DISADVANTAGE to using new.  That is not the wording one uses if new is so much better as you seem to suggest."
Of course Fresenius isn't going to say anything about reuse being bad.  As I pointed out, they have a history with it and I imagine they don't want to be liable for what they have done in the past.

As for our dualing studies, you've got ONE that says maybe it isn't so bad - I seem to have a whole lot more that says it is bad.  I don't know, maybe we can go back and forth all day with this study said this and that study said that; but what it boils down to for me is: Do I believe they get all of the cleaning agent out of dialyzers? -no.  Do I believe reuse degrades the performance of the dialyzer? -yes.  Am I going to let a relative of mine do this practice if I can help it? - h*ll no!

[BigSky]

Of course Fresenius isn't going to say anything about reuse being bad.  As I pointed out, they have a history with it and I imagine they don't want to be liable for what they have done in the past.

As for our dualing studies, you've got ONE that says maybe it isn't so bad - I seem to have a whole lot more that says it is bad.  I don't know, maybe we can go back and forth all day with this study said this and that study said that; but what it boils down to for me is: Do I believe they get all of the cleaning agent out of dialyzers? -no.  Do I believe reuse degrades the performance of the dialyzer? -yes.  Am I going to let a relative of mine do this practice if I can help it? - h*ll no!

You best go back and reread what you posted because most of what you posted was abstract and opinion.  Not "a whole lot of studies" and many of those opinions took information from the same study.   In fact you are basing your opinion on a outdated study that is making its judgment on outdated methods of processing reuse dialyzers.

Do they get all cleaning agents out?  Hmm depends.  By all standards its measured in ppm (parts per million) and every test strip we use shows 0 ppm and if it does measure even 1 ppm its not used until its clear. 

Downgraded performance.   Really,  Me, I know what my Kt/V is with reuse and I know what it is with new.  Too bad you cannot say the same thing can you.  Dialyzers used for reuse have to give information to the FDA and make sure they still work within guidelines specified.  It can vary with method of cleaning solution however the majority of centers use renlin these days so any downgrade is insignificant.  The only area of downgrade would be urea removal and that is only at 1 to 2% which is insignificant. Beta2-microglobulin clearance of polysulfone dialyzers remains unchanged.

I'm sure you wouldnt let a relative use reuse because you are basing you conclusion on unscientific studies on most methods that are no longer used by well over 90% of clinics in the US.

Past and current studies show mortality rate is higher in for profit centers than there is versus non profit centers. 

So are you telling relatives not to run in for profit centers also?


Currently with FMC owning by their own accord 70% of the dialysis machine market it seems they would benefit billions if they can push new vs reuse. So it seems it will benefit FMC far more than anyone else in the industry. 

[plugger]

I may get back to this later, but for one thing I recall test strips measure for a minimal amount of cleaning agent - not the absence of it.  I'm standing by what I've said, but I do hope you are right - however, there is still a whole lot that says you are not.

[Thalia]

my Mom's center said they do not reuse dializers because it was very difficult to completely remove the cleaning agent

[plugger]

Yes, that's what I've heard for years now and this seems to confirm that:

"Serim Residual Formaldehyde Test Strips

    * Meets AAMI standards of 5.0-ppm (and California standards of 3.0-ppm)"
http://www.serim.com/technical_tips_dialysis.cfm

They measure for less than 5.0 or 3 ppm - apparently they may not make it all go away.

[BigSky]

Majority of units no longer use formaldehyde.  They use renalin of which test strips start at 1 PPM.

[plugger]

Haven't heard much good about renalin either.  I did find this about renalin test strips:

After effective rinsing, a test strip should
show a color intensity that is <3 ppm.
http://www.minntech.com/renal/resource/renews/ReNews_v8.pdf

Anyway, let's say for a minute the reuse procedure is so good they can get every molecule of cleaning agent out - which I seriously doubt.  You still have to trust that some under-paid person working in a back room is going to get it right every time.  I have doubts it will happen.  In fact I can recall it not happening.

[plugger]

Also I got a reply from a lawyer friend about reuse.  He had this to say:

"Yes, patient has right to new dialyzer, but it is up to MD as to which one.  Fresenius now has a no-reuse national policy.  I have noticed that patients who kick and scream on this matter get what they want, but are told not to discuss it with other patients."

[BigSky]

Well our strips test start lower than that and each color indicates a higher ppm.  I will have to read the bottle again and get each measurement.

People do have a right to use single use dialyzers.  At anytime they feel uncomfortable by all means they should do what they feel is best.  THe situtation that Joe Paul described is not normal nor is it an optical illusion.  From what he describes it violates the rules set forth on reuse IMO.

While the doctor does pick the dialyzer, I did read once that units do not have to carry single use high flux dialyzers.  They can carry lower quality cost single use.  Doctors merely make a selection from which dialyzers the units carry.

You do know those same underpaid people also do all the stuff you dont see right?  Test water, make dialysate, bleach and culture machines and equipment.  Or do you think its only the area of them cleaning dialyzers we need to worry about?

[plugger]

Nice to see we can agree Joe Paul has the right to single-use.  And yes, I definitely know the techs are responsible for much more; that is why I helped get a state bill for tech certification started here in Colorado - it got passed by the way.  I recall reading a lot of complaints from different states and I was amazed at all the different things that can go wrong, but I don't think we will be going back to the days when just RNs were giving the treatments anytime soon.

As you say, getting the right dialyzer can be a problem too.  I know a lady who was on dialysis 11 1/2 years and she knew what dialyzer she wanted, but the Fresenius doctor wouldn't give it to her because it wasn't Fresenius made; she wound up with one that left her feeling wiped out after treatments.  Can you tell I have trust issues with both the major companies in this?

[Joe Paul]

Thanks for all the information guys. I informed the charge nurse yesterday that I do not want to keep on using the re-usable dialyzer. After only 5 uses, the thing looked crappy again. She wrote on my chart "patient refuses recommended re-use dialyzer".

[plugger]

Great to hear!  Even if I trusted this reuse practice, something doesn't sound right.

[qwerty]

bottom line is by law everyone on treatment has the right to "refuse" re-use dialyzers. I know it's part of the consent forms we use (soon to be former employer Davita in 2 days lol). We are encouraged to push re-use primarily due to "cost containment". It cost more to use dry packs then the re-use and the company doesnt get paid any additional dollars to use dry packs. Re-use techs do the cleaning but when it comes to checking water, mixing dialysate, cultures etc it's a licensed person such as LPN, RN, or the Biomedical team that does this (at least in my state). I dont like the idea of reuse myself as a professional but then again I have patients who react to dry packs and have no choice but to use reuse also. I was informed yesterday of a new patient utilizing reuse who failed to inform our clinic they are HIV positive and has been getting reuse. We are now changing him to a dry pack although he's been with us 4 weeks now. Also the machine the patient has been assigned to hasnt been bleached between patient use as it's supposed to be because of the patients failure to inform. We found it when we got his medical records from previous health provider. Also they are supposed to check for renalin clearing every time prior to putting on a patient and also have the patient identify it is thier dialyzer being used to ensure someone elses isnt put in its place. ( I have seen this happen and patient ran entire treatment on someone elses reuse dialyzer). They may not tell you but you can and have every right to refuse reuse!!