I'm a new patient, not a tech, but I figured someone in here could answer me. The facility I am going to has said that the limit to reuse the Baxter membrane is 13 uses before they throw it away and start with a new one. Is this correct? And if so, where does the oversight come from that established that 13 was the safe amount of times to re-use?
Thanks very much for any info anyone can give me!
You may want to get a copy of the NKF�s brochure on reuse entitled �What you Should Know About Dialyzer Reuse:� This brochure is available at meetings or from:
The National Kidney Foundation
30 East 33ed Street
New York, NY 10016
In this brochure it is stated that, �There is no set number of times that is considered safe for dialyzer reuse. As long as the TCV test shows that the dialyzer is working well, and the dialyzer looks clean, it should be safe for you to reuse your dialyzer�..�
I that think for new patients this may be a very helpful book.
As long as the dialyzer passes on your automated machine it is acceptable. The machine tests the integrity of the membrane. I used to work for a company that averaged 26 reuses, and max was 99. Pt.'s did well without complications.
In one unit in which I worked, they did not have a maximum reuse number set, as long as the dialyzer passed the tests on the DRS-4 we kept using it. The highest number I ever saw was 91 reuses. As I understand it, the main reason for the number of reuses being set so low is that some dialyzer fibers have been known to actually stretch after numerous reuses, allowing them to pass the tests on the automated reuse machines, but also allowing larger (and unwanted) molecules to be able to pass through. So, the number was set low for the safety of the patient.
First what is the method of reuse performed,
heat or chemical and if so what type of chemical?
The cut-off number is an arbitrary number as there has been no data suggesting that chemically processed dialyzers should not be used beyond a certain number of reuses, if the performance criteria is met - passed leak testing and fiber bundle volume is better than 80% of the original bundle volume.
In the case of heat sterilization the statistical maximum reuse number is 15. Beyond 15 reuses the incidence of blood leaks increases dramatically.
The maximum use or reuse number you mention 13 is relatively low, as most facilities that I've had contact with have either no maximum use number or establish a maximum use number between 25 and 50 uses, though I do know of facilities that set the maximum number as high as 100.
[This message has been edited by Dennis Todaro (edited 09-09-2000).]
When the FDA required manufacturers to relabel dialyzer for multiple use they used 15 for the data that was submitted to the FDA. This means that the dialyzer was only tested to 15 and I would suggest that this is the maximum per the dialyzer manufacturers data. Anything over that has not been tested with respect to the FDA guidance document on multiple use.
Your question is one of the most hotly debated issues, that I have seen on the Internet. As you have seen, just in this forum, the rapidity and range of replies is quite something.
I think that the main issues are NUMBER ONE: Is it safe? Number Two: Is it in the patient's best interest. I think all the other questions are so subjective that any answer could be correct.
My answer to #1, Yes, reuse is safe!
This is where people jump in and say "But what if?"
My answer to #2, Yes, reuse is one of many different things done in the dialysis field to save money on cost of treatment. Reuse also has been very contriversial (sic) and therefore the patients well being has been monitored more closely. Thus
the patient has been probably receiving better treatment, both by the monitoring and by the availablity of a little more money to pay for the lower priority items,
like new machines, chairs, etc.
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