I cannot believe how little information to patients there is about the negative side effects of reuse of hemo filters. I'm begining to believe everyone is looking the other way or paid off.

It would seem that your lack of information regarding this subject is letting you make an unfair blanket statement about it. Reuse, when done CORRECTLY is safe. The problems occur when proper policy and procedure are not followed. Can you honestly believe that a procedure which has been used for many years on thousands of patients is unsafe and the nephrologists knew and did nothing about it?

I was told it was safe, too, but had numerous symptoms with it such as RLS on the machine, fevers post dialysis (felt warm all over all evening), joint pain and a feeling like my body was buzzing inside. I switched to single use and Viola... ALL symptoms gone! It states right in the contract I had to sign with my co. that reuse may produce some of these symptoms and that there is no certaintly of long term effects. Most importantly, before I made the decision to end reuse I searched for documentaion on the FDA approval of the chemical sterilant used and could find absolutely nothing. In fact, I found that it had never been approved by the FDA! The company that makes it would not provide documentation! I am most happy I got off reuse. It was never explained to me, initially, by my company. I feel they most definitey slipped it in on me without my full understanding and knowledgeable consent and found that this is a widespread occurence.

This discussion topic raises interesting issues that come up again and again on the Internet. Are these discussion forums useful in helping people make intelligent decisions about their own care or the care of their patients? Do they instead introduce so much misinformation and damage the pursuit of truth so much that they actually do more harm than good? Why would scientific researchers want to enter into an exchange of ideas and dialogue with anonymous individuals who have not invested the time, effort, and discipline required by the Scientific Method?

But first, permit me to tell a story.

There were three men who were asked to quickly identify an object by touching it while they were blindfolded.

The three blindfolded men were led to a clearing where an elephant stood. Each man approached the elephant from a different direction.

The first man touched the elephant�s trunk and said, �It is a hose�.

The second man touched the elephant�s tail and said, �It is a broom�.

The third man touched the elephant�s leg and said, �It is a tree�.

All three had unique, honestly reported experiences. Their conclusions were supported by the information available to them. Each arrived at "their truth", but none discovered or saw the greater truth.

In the dialysis world, you can find many different viewpoints about dialyzer reprocessing (reuse). There are administrators and technicians who run well-managed reuse programs. There are patients who have been treated with reprocessed dialyzers and have never had any problems related to reuse practices. There are patients who have had problems related to dialyzer reuse. There are patients and staff who have mistakenly attribute problems to dialyzer reuse. Speak to any of these people and you will get their truth about reuse as they know it.

There is also scientific truth, or more aptly put, the Scientific Method. It is a process that, if designed and executed well, removes most personal bias from the quest for the truth and provides verifiable, repeatable results. The Scientific Method requires data to be collected for analysis. Essentially, there are two kinds of data that must be collected:

- anecdotal data is related in words and describes what happens in an experiment, during chance observations, as well as describing mistakes and unexpected events.

- numerical data consists of measurements determined by a person or instrument.

Collecting data is a time-consuming, tedious process, and patience is an essential ingredient in science. As results accumulate, the researcher tries to find patterns or relationships in the data.

Data must then be interpreted by asking critical questions. This is essential to determining the cause and effect of experimental observations. When the results of repeated tests are consistent and patterns become discernible, only then are the results reported.

(For those of you wanting to know more about the Scientific Method, click here for information and explanations from UC Riverside and Vision Learning.)

Before the Internet, the only medical information that was published for widespread distribution was in scientific journals. Articles published there were reviewed by experts in the field, reanalyzed, criticized, checked for accuracy, and in the end backed by the author�s name and reputation. This process removed much of the personal bias and prevented most inappropriate conclusions from reaching publication. It also meant that only those that had invested large amounts of time and effort could participate in the publication process.

With the coming of Internet discussion forums, everything changed. Anyone can publish unverified information for thousands to see. These forums allow individuals with limited knowledge and experience to publish their �truth� without criticism or peer-review. Raw anecdotal data are now frequently offered without analysis or review as conclusive proof to support theories and agendas. Like the men examining the elephant, there are some individuals inappropriately analyzing their experiences and making sweeping generalizations � and publishing it as �the truth�.

The Internet also allows individuals to post anonymously and suffer no consequences for misrepresenting, creating, fudging, or falsifying information. The Internet also allows one individual to post under several different names to create an appearance of consensus, validation, and agreement. While some will make a case that anonymous postings allows individuals to act a whistleblowers, the vast majority of postings in this vein are simply propaganda that supports personal agendas.

Understanding a person�s motivation for posting a message is essential � which is impossible with anonymous postings. Emotionally charged situations and disputes often lead to disgruntled employees and patients. A few of these individuals are using anonymous postings on the Internet to promote personal agendas. Unfortunately, some individuals have also used anonymous postings on the Internet to promote their products. They damage the pursuit of truth by misrepresenting themselves as well as information found in scientific texts.

There are commendable individuals who are careful to identify their writings as opinions and welcome all possible credible explanations for their personal experiences. It may also be true that many people are simply not aware of the importance of these distinctions and actions when sharing their personal experiences in a scientific discussion forum. Hopefully, the discussion forum moderators can help people move toward a scientific approach in their discussions. Also, all participants can help keep discussions on track and prevent them from simply serving personal agendas by (kindly) challenging inappropriate statements (as the second posting in this discussion forum does).

As for this posting that started this discussion thread:

"I cannot believe how little information to patients there is about the negative side effects of reuse of hemo filters. I'm begining to believe everyone is looking the other way or paid off."

This can serve as the example of "personal agenda" postings that are not welcome on RenalWEB. I encourage the moderators of this discussion board to delete this kind of posting. The purpose of these forums is to help dialysis patients and staff. Anything can be discussed on RenalWEB, but it will not be done through anonymous, inflammatory statements that simply promote personal agendas. The other rule for postings on RenalWEB is that if you criticize an individual, product, organization, or company, you must provide your true name and your current e-mail address.

In order to make an Internet discussion forum useful to the scientific community, it may be necessary to require registration with one�s true name and e-mail address and to not allow anonymous postings. The discussion forums on RenalWEB can be set up to only permit registered users to post message or to require all messages to be approved by the moderator before they are posted for the public. Please contact RenalWEB if you are interested in moderating a "purely scientific" discussion forum.

It is understandable that patients may not want to divulge their name with their medical information. Patients may also want to write about incidents that have occurred to them and seek guidance without mentioning names. Some discussion forums will have to be open to anonymous postings for these reasons.

Finally, if you are interested in a scientific report on reuse, the General Accounting Office (GAO) has released a report entitled,

"Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted".

The report focuses a great deal of attention on hemodialyzer reuse. (pdf version of the same report).

Here is a search result from the MEDLINE database for recent articles on dialyzer reprocessing from the National Library of Medicine.

As for the patient who wrote:

"I was told it was safe, too, but had numerous symptoms with it such as RLS on the machine, fevers post dialysis (felt warm all over all evening), joint pain and a feeling like my body was buzzing inside. I switched to single use and Viola... ALL symptoms gone! It states right in the contract I had to sign with my co. that reuse may produce some of these symptoms and that there is no certaintly of long term effects. Most importantly, before I made the decision to end reuse I searched for documentaion on the FDA approval of the chemical sterilant used and could find absolutely nothing. In fact, I found that it had never been approved by the FDA! The company that makes it would not provide documentation! I am most happy I got off reuse. It was never explained to me, initially, by my company. I feel they most definitey slipped it in on me without my full understanding and knowledgeable consent and found that this is a widespread occurence.

I would offer these comments�

First, I hope that this is actually a patient and not someone pretending to be a patient. It may also be the same person who started this discussion thread.

The patient had symptoms that he/she attributed to reuse. For this example, we will assume these symptoms are real. The patients attributes the symptoms to reuse, but a science-minded individual would be interested in seeing if it could be positively determined that the use of reprocessed dialyzers is the actual cause. A scientist would set up a double-blind study where neither the patient nor the staff would know when a reprocessed dialyzer was being used. The patient would be interviewed about symptoms he/she experienced after each treatment. Only after all the treatments in the study were completed would it be revealed to the patient and the staff the actual dates that a reprocessed dialyzer was used. If there were a statistically significant correlation between the reported symptoms and the use of reprocessed dialyzers, then the scientist would agree with the patient. The scientist would also ensure that the reprocessing process was closely monitored and all reuse practices were well documented. If the study showed no correlation between the symptoms and the use of reprocessed dialyzers, but the symptoms returned when returning to �standard� reuse, the scientist might then begin looking at individual nurse or technician practices, sterilant solutions, residual testing solutions, and other possible factors. These investigations might lead to a discovery that could help all patients on reuse.

The patient states that he/she "searched for documentation on FDA approval of the chemical sterilant and could find absolutely nothing. In fact, I found that it had never been approved by the FDA! The company that makes it would not provide documentation." It seems to me that providing the name of product would allow knowledgeable industry people to respond to these statements. In their current context, the comments do not allow the truth to come out and seem instead to serve a personal agenda against reprocessing.

The patient states, "I feel they most definitey slipped it in on me with my full understanding and knowledgeable consent and found that this is a widespread occurrence." The use of the statement "I feel�" indicates a personal opinion � to which the patient is entitled. The second half of the sentence, however, states, �and found that this is a widespread occurrence�. A scientist would want to know how many people you talked to, what questions were asked, under what circumstances were the questions asked, etc.



[This message has been edited by Gary Peterson (edited 04-25-2001).]

Gary,

Mick Richey is my real name and my email address is Mick.Richey@nsc.com or katynmick@cs.com, you choose. I have gotten a wealth of information off of this board. I am a well educated, relativedly intelligent, independent thinker. I have also been a kidney patient for nearly 20 years. I would like to hear more information about the sterilant used on the dializers rather than a rambling message about the evils of the internet and misinformation. Instead of telling me this guy needs to back his concerns up with data and we shouldn't listen to things that are posted, how about telling me more details of why reuse is OK? Your justification that this practice would not be done in thousands of clinics if it were not safe, does not hold water. Many times medical treatments have been used widespread only later to be be deemed unsafe. When I first went on dialysis, I was put on high daily doses of calcium, as a phosphorous binder. You don't see that being done today. I am not saying that reuse is bad or good. I am concerned about the sterilant and I will seek out more information about it. Please don't discourage people from posting. I would also offer up to you that a patient who lives with renal failure and goes through the process for years, probably knows more about its affects on the patient than someone who has read about.

quote:

Originally posted by Mick Richey:
Gary,

Mick Richey is my real name and ...... Instead of telling me this guy needs to back his concerns up with data and we shouldn't listen to things that are posted, how about telling me more details of why reuse is OK? Your justification that this practice would not be done in thousands of clinics if it were not safe, does not hold water......

Please reread my posting. I did not argue for or against reuse. I did not attempt to justify reuse practices or their safety.

More than anything else, I feel that people want medical information on the Internet to be reliable.

[This message has been edited by Gary Peterson (edited 06-08-2001).]

Well, live and learn! I don't have a problem with reuse. They do it at the unit I go to; they check for residual chemicals in front of me, with a test strip.
Luck me, I have a problem when they change my kidney. They seem reluctant to believe me. I get flu like sypmtoms that night and the following day. They use a dry pack. Lin.

Lin, I also had "first-use syndrome" and was told that I was imagining it! Well, after numerous "first use" crashes, I finally gained some credibility. When we moved to no reuse last month, I was ready to have a tough time, but luckily they do run saline through the dialyzer before treatment, and so far I have not had any problems.

Just because a symptom is "statistically minute" doesn't mean there aren't people who are affected by it! To hear that you're in the point-three percent of people with the symptom doesn't help when you're in T-berg for 2 hours and getting pumped full of saline.

They told me "very few" have a problem, but they could run a saline rinse through the new kidney if I preferred. I just smiled and said "I would appreciate that"!

When I started dialysis, I knew nothing. I assumed that my health was in good hands. Every time we started up, I had such violent reactions that the techs would circle around ready to react. Knowing no other way,, I went through this for most of the first year. Then I finally asked the RN if there was any other way, and VERY reluctantly she told me about single use, but subtlely tried to talk me out of changing. Since I changed to single use, I have no crashing on start-up, no "jet rushes" on tx, no night sweats, no fevers, etc. I ws so astounded that the "Nightinggales" at my unit would expose me to a tx they knew to be dangerous that ever since I have questioned and researched every part of the TX. Yes, I'm a royal pain in the *** , but I'm the healthiest patient in my unit. Re-use is a matter of dollars. They make more money on re-use. Read the FDA prohibitions about renalin. Imagine, why would Fresenius be moving to total single use. It's from the dark ages of dialysis, and will go the way of blood letting and other dark ages practices.

Forgive me...posterior, glutes, tush?

Reactions to dialyzers, their membranes, their potting compounds, the plastics, and then the Renalin that is used to reuse dialyzers and the water supply can all be factors in reactions in dialysis. If your unit is using Dry paks, have them prime the dialyzers with 500 mls, and then do a 500 ml recurc engage the dialysate. This will ensure that any renalin, or any of the Sterilants like ETO, or Gamma are rinsed out.

Not only could be residual renalin, but it could also be the sterilization method that the manufacturer uses to make sure the dialyzer is sterile. 1 out of 1000+ patients will have some sort of first time reaction to a dialyzer. To help eliminate this, make sure your units are priming the dialyzer and doing a recurc of a total of 1000mls of saline. I have my own opinions to reusing life saving devices

For those of you who experience or treat patients who experience a first use syndrome reaction: Fresenius has a new process available for sterilizing dialyzers. The dialyzers are called E-Beam (?electronical beam sterilized). I have seen this single use dialyzer used with success on a patient who had SEVERE first use syndrome.

I realize I am not stating anything new, but I have to agree with some of the earlier post's, re-use of dialyzers is a safe procedure, providing it is performed by competent staff who follow good procedures. While the biggest advantage to reuse, is the financial savings to the unit. There are however, well documented advantages to re-using certain types of dialyzers and the reduction of cases of first-use syndrome.
Also, Honey, in your post you mention a type of disinfection called E-Beam? I am unfamiliar with this, could you point me in the direction of where to find documentation on this?

Re-use IS a matter of money. That doesn't mean it is unsafe. When performed correctly
studies fail to show a cause and effect for
patient morbidity. Fresenius is moving to single use as a money issue. They have become the largest manufacturer of dialyzers
and as a vertically integrated corporation this move will enhance their stock value (which is in the tank). We have had good results with gamma radiated dialyzers for non re-use reaction syndromes. As a patient
it is your right to refuse re-use without fear of retribution. Personally I grow weary
of patient attitudes that seek to find some
kind of "plot" in this industry. Since the average age of RN's in our units is hovering around 48 I wonder who will be taking care of this cadre of disgruntled individuals in the future...........