Dialyser reuse-associated mortality and hospitalization risk in incident Medicare haemodialysis patients, 1998–1999

Nephrology Dialysis Transplantation, May 2004

Background. The reuse of haemodialysers has been practiced in the United States for >20 years. We investigated mortality and hospitalization risk according to various reuse practices, testing the hypothesis that outcomes are improved in patients treated with dialysers cleaned with bleach and sterilized with formaldehyde. Methods. We studied 1998 and 1999 incident Medicare haemodialysis patients, with follow-up through December 31, 2000 (49 273 patients). Clinical conditions and dialysis therapy were characterized from Medicare claims data. Included were patients who could be linked to a dialysis provider. Demographic characteristics were obtained from the Centers for Medicare and Medicaid Services (CMS) Medical Evidence Report. Mortality information was obtained from the CMS ESRD Death Notification; hospitalization information, from Medicare in-patient claims files. Data on reuse practices were obtained from the annual survey of haemodialysis units conducted by the Centers for Disease Control and Prevention. Results. Cox regression analyses found no significant differences in mortality or first-hospitalization risk for patients in dialysis units not using bleach as a cleaning agent. Outcomes for patients treated in units using glutaraldehyde did not vary according to use of bleach. In the analysis of first-hospitalization risk, there was no difference according to various germicide/bleach combinations. Overall, there was no significant difference in relative risk of death or in hospitalization risk among the reuse groups (including the no-reuse group). Conclusions. For the 1998–1999 period, reuse practices were not associated with a survival advantage or disadvantage. Our findings may reflect the National Kidney Foundation's 1997 introduction of clinical practice guidelines, the intent of which was to bring about increased consistency of care within the dialysis community in the United States.

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Dialyser reuse-associated mortality and hospitalization risk in incident Medicare haemodialysis patients, 1998–1999

Nephrol Dial Transplant Dialyser reuse-associated mortality and hospitalization risk in incident Medicare haemodialysis patients, 1998-1999 Allan J. Collins 0 1 2 Jiannong Liu 1 2 James P. Ebben 1 2 0 Hennepin County Medical Center , Minneapolis, MN , USA 1 FACP, Nephrology Analytical Services, Minneapolis Medical Research Foundation , 914 South 8th Street, Suite D-206 2 Nephrology Analytical Services, Minneapolis Medical Research Foundation , Minneapolis, MN Background. The reuse of haemodialysers has been practiced in the United States for >20 years. We investigated mortality and hospitalization risk according to various reuse practices, testing the hypothesis that outcomes are improved in patients treated with dialysers cleaned with bleach and sterilized with formaldehyde. Methods. We studied 1998 and 1999 incident Medicare haemodialysis patients, with follow-up through December 31, 2000 (49 273 patients). Clinical conditions and dialysis therapy were characterized from Medicare claims data. Included were patients who could be linked to a dialysis provider. Demographic characteristics were obtained from the Centers for Medicare and Medicaid Services (CMS) Medical Evidence Report. Mortality information was obtained from the CMS ESRD Death Notification; hospitalization information, from Medicare in-patient claims files. Data on reuse practices were obtained from the annual survey of haemodialysis units conducted by the Centers for Disease Control and Prevention. Results. Cox regression analyses found no significant differences in mortality or first-hospitalization risk for patients in dialysis units not using bleach as a cleaning agent. Outcomes for patients treated in units using glutaraldehyde did not vary according to use of bleach. In the analysis of first-hospitalization risk, there was no difference according to various germicide/bleach combinations. Overall, there was no significant difference in relative risk of death or in hospitalization risk among the reuse groups (including the no-reuse group). Conclusions. For the 1998-1999 period, reuse practices were not associated with a survival advantage or disadvantage. Our findings may reflect the National Kidney Foundation's 1997 introduction of clinical practice guidelines, the intent of which was to bring about increased consistency of care within the dialysis community in the United States. chronic kidney failure; morbidity; mortality; renal dialysis Introduction Reuse of haemodialysers has been a consistent practice in the United States for >20 years. In the last 10 years, the practice of reusing dialysers increased to 81% of dialysis units, then declined slightly through the year 2000 to 78% of dialysis units [1]. Peracetic acid mixture, formaldehyde and glutaraldehyde have been the predominant types of germicide used in reuse practices in the United States. In 1991, almost 50% of reuse units were using peracetic acid mixture; by the year 2000, 62% of reuse units were using peracetic acid mixture [1]. The continued practice of reuse in the United States has been controversial; its safety has been disputed by a number of investigators [2–5]. Recent data (through 1996) have shown that there is little difference in outcome for US patients treated with reused dialysers versus those treated with single-use dialysers, a finding that differs from findings of studies conducted in the late 1980s [2,4,5]. The membranes used in the United States have changed dramatically in the last 10 years, with synthetic high-flux dialysers (as opposed to cellulose-based dialysers) being used more and more commonly [1]. Some investigators have hypothesized that reuse of high-flux dialysers with certain germicides may be associated with reductions in large-molecular-weight clearances, which may affect patient outcomes [6–8]. However, reuse practices that include the cleaning of high-flux dialysers with bleach (vs peracetic acid but no bleach) appear to be associated with improved large-molecular-weight clearance [9]. An observational study found a lower risk of death in patients whose high-flux dialysers were cleaned with bleach, as compared with other cleaning practices [9]. This finding was obtained using data on prevalent patients in December 31, 1993, with follow-up into 1994. Because clinical practices changed significantly during the ensuing years and increased attention has been paid to the quality of dialysis, anaemia treatment and reuse practices, we investigated reuse-associated mortality and hospitalization risk in 1998 and 1999. These were the most recent years governed by clinical practice guidelines from the National Kidney Foundation [10] for which data were available. We also chose the years 1998 and 1999 because the Centers for Disease Control and Prevention (CDC) surveillance surveys of dialysis units included data on reuse practices, including bleach cleaning. It has been hypothesized that outcomes are improved in patients treated with high-flu (...truncated)


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Allan J. Collins, Jiannong Liu, James P. Ebben. Dialyser reuse-associated mortality and hospitalization risk in incident Medicare haemodialysis patients, 1998–1999, Nephrology Dialysis Transplantation, 2004, pp. 1245-1251, 19/5, DOI: 10.1093/ndt/gfh011