Sick of it
Joined: 11 Feb 2003
Posts: 46
Posted: Sat May 10, 2003 4:14 am Post subject: FDA Investigated Renalin In 1992-They Recognized Danger
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Can you believe that as far back as 1992 the FDA reviewed two different Health agency studies that were concerned with the affects of Renalin and other sterilants on Dialysis patients! Although preliminary at that time, the findings prompted FDA to issue strong guidelines with possible enforcement actions to clinics and manufacturers...........but where is the rest of the story? <
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>The study was biased toward mortality, but you can feed a victim small doses of Arsenic 3 times a week and they may not die, but just feel like Hell all the time !<
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>Does anyone else smell a RAT? The article Proof source follows:<
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>Answers 10/13/1992 <
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>T92-46 SharonSnider<
>Oct. 13, 1992 (301)443-3285<
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> FDA MEETS WITH DIALYSIS COMMUNITY TO DISCUSS NEW DATA ON DISINFECTANTS<
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> The Food and Drug Administration met with kidney dialysis experts, manufacturers of dialysis products and patient representatives on Oct. 8 to review preliminary data relating to disinfectants used on dialyzers. The data suggest an association between one or more disinfectants or methods of using them and increased mortality in dialysis patients. Dialyzers are devices that perform the function of failed kidneys by filtering impurities from the blood.<
> Two studies were discussed:<
> --One showed increased mortality in facilities where dialyzers are <
>reprocessed either with a disinfectant containing peracetic acid combined <
>with hydrogen peroxide or a disinfectant containing glutaraldehyde. This <
>study was performed by the Urban Institute with support from the Health Care <
>Financing Administration (HCFA).<
> --The other study, performed by the National Institutes of Health, <
>showed increased mortality only when dialyzers were disinfected manually <
>with peracetic acid-hydrogen peroxide. Use of this disinfectant in <
>automated cleansing systems was not associated with higher mortality. Also <
>in this study, glutaraldehyde was not associated with higher mortality.<
> -MORE-<
> Page 2, T92-46, Dialyzers<
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> Neither study showed any increase in mortality associated with use of a <
>third disinfectant, formaldehyde.<
> Although the findings are preliminary and do not explain how the <
>disinfectants are associated with a higher death rate, FDA is taking a <
>number of precautions:<
> * The agency has asked the manufacturer of Renalin, the peracetic <
>acid-hydrogen peroxide solution, to notify dialysis facilities about the <
>study results and provide technical assistance on proper use of the <
>disinfectant.<
> * FDA is making a series of recommendations to dialysis centers. These <
>include strict adherence to standards for reprocessing dialyzers for <
>re-use. HCFA will conduct surveys of the centers to ensure compliance with <
>standards.<
> * FDA will notify medical organizations to inform their members about <
>the study and the steps that dialysis centers are being asked to take.<
> * The agency will require manufacturers of dialysis equipment to <
>include instructions for proper reprocessing in their labeling.<
> * Together with other agencies within the Public Health Service, FDA <
>will continue to conduct research to further explain the findings.<
> "We want to emphasize that the study findings are very preliminary," <
>said James S. Benson, director of the Center for Devices and Radiological <
>Health. "At this time, it is unclear what is causing the higher mortality <
>rates. It could be the disinfectants themselves, or it could be the way <
>dialysis facilities are using them. Or there could be other reasons. <
>Regardless, the actions we are taking are designed to help ensure the safety <
>of dialysis patients."<
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>
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Hey
Joined: 10 May 2003
Posts: 3
Posted: Sat May 10, 2003 7:43 am Post subject: Old
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This is an old article.
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And
Joined: 10 May 2003
Posts: 1
Posted: Sat May 10, 2003 10:32 am Post subject: the
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study that prompted this action was found to be VERY flawed and biased and was subsequently retracted and a "public" apology made!
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aprnjam
Joined: 28 Apr 2003
Posts: 85
Posted: Sat May 10, 2003 4:49 pm Post subject: Re: the
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To find more current articles on this topic go to
http://www.medscape.com./ It is a medical website, but anyone can join as a reader. It will also provide you links to Medline and other medical websites where you can obtain newer medical articles than 1992.
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Advocator
Joined: 16 May 2003
Posts: 2
Posted: Fri May 16, 2003 10:37 am Post subject: APRNJAM-
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APRNJAM: Specifically, do you know of articles that support or disprove the study results reported and acted upon by FDA at the time of the posted reference?<
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>I am curious about the retraction and "public apology" refered to by other contributor as well. Does anyone know where this information can be found, or can you list the article references please?<
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>I assume that there must have been very positive clinical results then for continuation of RENALIN use...can someone post the journal articles or references? <
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>Thanks, just wondering how such a thing once exposed, could be buried? I've tried all the resources you mention, and I am familiar with, and turn up none of the studies that should disprove the negative press at that time on RENALIN.
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Oh dear
Joined: 03 May 2003
Posts: 2
Posted: Sat May 17, 2003 4:33 am Post subject: here we go again
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You find all kinds of information on the FYI and in archeives.<
>Second of all it is cleared as a device only. There is a book written on the chemicals in renalin, from a DR. Lipsky. I know that this board posted much of the book there. I will find the name of the book for you. Its about $100.00,but much information is there also, reports,statistics and information. That is only one source. Any study that is or was done is by the company themselves. <
>I would suggest you call them and ask why the FDA was going to pull it or make them do more accurate labels. I would suggest you call them and ask them why they are suggesting that "house hold 409" a petroleum based product is used to clean and disinfect their Renatrons instead of their chemical. My understanding is that the Renalin is not gentle on the tubing. My understanding is that they had to change formulas, in 1992 or 1995.Why?<
>My understanding is that the EPA took Paracitic Acid off the list as a dangerous pesticide. But they claim it is a higher dose. A little arsenic over a period of time goes a long way.<
>I would ask those question to them. Ask them if there is any outside information or studies that they have not done or paid for. A neutral source.Get Dr. Lipsky's book, you can find it on the internet....!<
>You then can ask FDA what the criteria is to find out what it takes to put this on the market<
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>Canada uses it a a sterilant, true, but not in the dialysis patients but surgical insterments.<
>It will hemolize the blood and could kill you. With the new trainies that come in and are clueless and are thrown on the floor with only being mentored for an average
of 6 weeks, with maybe 10 hours of book work, are worked into such a frenzy and assembly line atmosphere. It is about profit and these companies would lose millions.<
>I would love to sit down with Minntech and ask several questions of them. I would want to ask why many workers across the country are having nose bleeds,edema and asthma that have been downloading our information on the chemical as they have no information other than the MSDS. I personally almost passed out from the smell of Renalin my first day of training. I felt light headed, like taking iron on an empty stomach.<
>I did get a response from Minntech yesterday. This was the first time that they ever responded. They have a new CEO. I tried to call him yesterday, but he was out of the office. I would love nothing more than to dialogue about this. I will call him again on Monday. With what I have and am seeing coming into here at dialysisethics, I am frightened, as the 510k process with the FDA is pretty lacked and the companies submit the research and just have to prove that they have in FDA a simular product already there.<
>I dont understand the 409 being used and if that is even cleared or has to be cleared by FDA. We have been working on that. But I will ask questions and I will dialogue our concerns.It is a prescription item.<
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>We know it is used to maximize the profit for the companies.<
>We know that the patients are not given the choice that they are intitled to as "informed consent" that is offered to every other patient. My concern is that the patients are clearly told about the "first use syndrome", but not about what happens if the chemical is not rinsed out, and what is the residual on the chemical.<
>A patient should have a choice and why would one chose to use something that is 80% effective and filled in chemicals or 100% and no chemicals in a dializer. But it would cut out profit if a patient didnt use reuse. It costs the clinics not only a new dializer but an extra bag of saline.<
>Many patients that come back to us with testamonies also state that they feel better and leave the clinics feeling better after the treatments. It amazes me if it is to be a choice, why arent the patients told all sides of this re-use issue and not informed of the dangers.<
>We will see if they will dialogue, we did get a letter. <
>As far as statistics on the deaths that are caused, there are none, as most patients go to the funeral home of their choice and autopsies are "rarely" done.
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REUSE
Joined: 22 Feb 2003
Posts: 5
Posted: Sat May 17, 2003 6:09 am Post subject: Pub Med
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<
>Beta(2)-microglobulin clearance decreases with Renalin reuse.<
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>Castro R, Morgado T.<
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>Unidade de Hemodialise, Servico de Nefrologia-Hospital S. Pedro, Vila Real, Portugal. ruicastro@hvreal.min-saude.pt<
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>The HEMO study revealed that beta(2)-microglobulin clearance decreases over time with Renalin reuse in the high-flux group. It was suggested that the reuse of polysulfone or cellulose triacetate high-flux dialyzers with Renalin (without bleach) results in degradation of the high-flux capacity. At our haemodialysis unit (Vila Real, Portugal) we reused dialyzers until January 2000 (limited to 10 reuses), with an automatic machine Renatron (Renal Systems, Minntech. All of our 31 patients who started with postdilution haemodiafiltration on-line (HDFol) were always dialyzed with F-80 polysulfone (Fresenius). The reposition rate was 10 litres/session until 1998 and 20 litres/session thereafter. Reuse techniques were abandoned in our country in January 2000 following an EEC directive. Thereafter, we have decided to maintain HDFol with the same dialyzers without reuse. The mean beta(2)-microglobulin predialysis values did not decrease over time until reuse was terminated (1995 with low-flux haemodialysis: 25.4 +/- 6.4 microg/l; 1997: 24.7 +/- 6.6 microg/l; 1998: 29.2 +/- 8.9 microg/l; 1999: 33.7 +/- 4.7 microg/l) whereas beta(2)-microglobulin clearances were reasonable with HDFol (1998: 56.4 +/- 25.9 ml/min; 1999: 47.9 +/- 16.4 ml/min). After stopping reuse we have noticed that predialysis beta(2)-microglobulin values decreased (2000: 23.0 +/- 3.9 microg/l) in accordance with beta(2)-microglobulin clearance duplication (2000: 84.1 +/- 25.0 ml/min; p < 0.01). It is our opinion that the reuse of polysulfone dialyzers with Renalin should be abandoned in the field of high-flux haemodialysis. It causes deterioration in the beta(2)-microglobulin clearance and probably interferes with the high-flux haemodialysis benefits, namely the reduction of dialysis-related amyloidosis. Copyright 2002 S. Karger AG, Basel<
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>PMID: 11867958 [PubMed - indexed for MEDLINE] <
>
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leadsag
Joined: 31 Oct 2002
Posts: 263
Posted: Thu May 29, 2003 12:14 pm Post subject: what happened to 5/29 post
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It says last post is from 5/29 but when you try to read the post the last one is from 5/17. Is there "editing" of posts happening again?<
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>I feel that all viewpoints should be allowed to be expressed on this board. I hope that everyone is allowed to express an opinion on here with out fear of 'if your not with us your against us' philosphy of the current govt. regime. People can still be with the agenda of this group but have a different opinion on matters and be allowed to express them.<
>
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aprnjam
Joined: 28 Apr 2003
Posts: 85
Posted: Thu May 29, 2003 8:28 pm Post subject: Re: what happened to 5/29 post
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I agree that all posts should be available and I will ensue Arlene is aware of the missing post when she returns on Tuesday.<
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>Joyce
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FRN
Joined: 24 Feb 2003
Posts: 25
Posted: Fri May 30, 2003 7:42 am Post subject: Industry at it again.
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Leadsag and Joyce,<
> The post in question was deleted as it was from a well known trasher of this site. When I posted that Arlene was out of the office for a vacation, I knew this would happen. This one didn't waste any time in taking advantage of the information.
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aprnjam
Joined: 28 Apr 2003
Posts: 85
Posted: Sun Jun 01, 2003 12:59 am Post subject: Re: Industry at it again.
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FRN,<
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>Thaks for letting me know! I didn't have a chance to read it before you deleted it, you are really on the ball!!! GREAT JOB!! Everyone, please excuse my learning curve on these issues, I'm getting there, slow but sure!<
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>Joyce
