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)