ICU Nurse
Joined: 23 May 2003
Posts: 1
Posted: Fri May 23, 2003 2:32 pm Post subject: Why Fresenius Medical Care Decided Not to Reuse Dialyzers
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Why Fresenius Medical Care Decided Not to Reuse Dialyzers<
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>By J. Michael Lazarus, MD<
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>In the early 1970s, I joined with the late Dr. Peter Lundin in a pro and con debate on the use of reused dialyzers which was printed in this magazine. Peter argued against reuse of dialyzers and I supported reuse. My decision to recommend reused dialyzers for my patients (and to argue for that approach) was based on the fact that cuprophane mem
anes were being used at that time and there was a very significant occurrence of "first use" syndrome related to the exposure of patients to new cuprophane mem
anes. I also argued at the time, that dialyzers were expensive and reuse would allow dialysis facilities to use savings in other ways in the delivery of care for patients. My willingness to ask my patients to be dialyzed on reused dialyzers was based on my commitment that dialyzers would be properly processed and would be as safe as a new dialyzer. The American Association of Medical Instrumentation (AAMI) subsequently developed policies and procedures to assure safe dialyzer reuse.<
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>The vast majority of dialysis units and dialysis patients have utilized reused dialyzers over the ensuing years. With the availability of more biocompatible synthetic mem
anes in the late 1980s and early 1990s, concerns about "first use" syndrome and any medical advantage, however small it may have been, disappeared. However, synthetic mem
anes, which were developed in Europe and shipped to the United States, were extremely expensive. The only possible way to use dialyzers with synthetic mem
anes was to continue with reuse. In the 1990s, there were several studies with large retrospective analyses, which suggested that either reused dialyzers or certain chemicals used in the reuse process were linked to an increased mortality in those facilities in which reuse was utilized. This topic and the analyses have been hotly debated for a number of years with no clear resolution. <
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>In 1995, Fresenius USA made a decision to
ing the manufacture of dialyzers to the United States where they could be produced in greater quantities at a lower cost. Over the subsequent five years, this has been accomplished. Based on this capability, Fresenius Medical Care (FMC) recently made the decision to abandon reuse of dialyzers over the next two years. The two-year period is necessary because it will take that long to ramp up production of polysulfone dialyzers to an adequate quantity to supply all FMC facilities as well as Fresenius' external customers. We have come to the conclusion that the cost of reuse related to the cost of personnel, reuse materials, and compliance with federal and state regulatory issues regarding reuse, is now equal to or more than the cost of a new polysulfone dialyzer.<
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>We believe that our conversion to non-reuse will allow staff to dedicate more time and attention to other patient care issues. We believe there is no disadvantage whatsoever to patients receiving new kidneys utilizing polysulfone mem
anes. For those physicians and patients who are comfortable and confident with reuse, we will allow them to continue to utilize reused dialyzers if that is their wish. For those who choose otherwise, we now have the ability to provide high quality single-use biocompatible dialyzers.<
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>I wish my good friend, Peter Lundin, were here to see that we have arrived at an approach which he and I would agree is in the best interest of our patients and the program at-large.<
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>J. Michael Lazarus, MD is the Medical Director and Senior Vice President of Clinical Quality for Fresenius Medical Care North America (FMCNA). Dr. Lazarus is Vice Chairman of the Board of Directors of Renaissance Health Care, Inc., and is on the Board of Directors of Optimal Health Care, Inc. Both are FMCNA-affiliated companies. He is an Associate Professor of Medicine at Harvard Medical School.<
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>This article originally appeared in the January 2002 issue of aakpRENALIFE, Vol. 17, No. 4. <
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>? 2002 American Association of Kidney Patients, Inc. All rights reserved. Unauthorized use prohibited. The information contained in the American Association of Kidney Patients (AAKP) web site is not a substitute for medical advice or treatment, and the AAKP recommends consultation with your doctor or health care professional.<
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