Epidemiologic Notes and Reports
Update: Acute Allergic Reactions Associated
with Reprocessed Hemodialyzers -- United States, 1989-1990
In December 1989, clusters of acute allergic reactions
(AARs)* that occurred within 10 minutes of initiation of
hemodialysis at one dialysis clinic prompted an
epidemiologic investigation; findings of that investigation
suggested that AARs were associated with reused dialyzers
(1). To further characterize the extent of this problem and
to identify risk factors for AARS, in January 1990, a
questionnaire was mailed to all 1702 Health Care Financing
Administration-licensed chronic hemodialysis centers. In
March 1990, a telephone questionnaire was administered to
all centers reporting clusters** of AARs from January 1
through December 31, 1989, to assess clinical manifestations
of AARs, the total number of patients at each center, and
incidence of AARs. This report summarizes the results of the
survey.
Of 1290 (76%) centers that responded to the mailed
questionnaire, 762 (59%) reported reusing dialyzers, and 385
(30%) reported not reusing dialyzers; 143 (11%) did not
indicate whether they reused dialyzers. Of the centers
reusing dialyzers, 32 (4%) reported patients with AARs
(median: six AARs per center; range: 2-40 AARs per center)
associated with reprocessed dialyzers. Of the 1290 centers,
38 (3%) reported patients who had experienced
anaphylactic-like reactions with new, unused dialyzers; 16
(42%) of the 38 were centers that reported not reusing
dialyzers.
Analysis of treatment characteristics and reprocessing
practices of centers reusing dialyzers indicated that AAR
clusters with reprocessed dialyzers were not associated with
the type of disinfectant product, the reprocessing method
(manual or automated), or type of dialysate (bicarbonate,
acetate, or both). Based on multivariate analysis, however,
the risk for clusters of AARs with reprocessed dialyzers was
higher with use of a specific heparin product (odds ratio
(OR)=3.1; 95% confidence interval (CI)=2.3-3.8) and with
washing the hemodialyzer blood compartment with either
bleach or hydrogen peroxide (OR=2.5; 95% CI=1.7-3.3).
In September 1990, a follow-up telephone survey found
that, following modification of dialyzer reprocessing
practices because of AARs, only two (6%) of the 32 centers
that had reported clusters of AARs again reported AARs. Of
the 32 centers, six stopped dialyzer reuse for patients who
had experienced AARs, six changed the type of hemodialyzer
membrane, five changed disinfectant products, and five
discontinued washing hemodialyzer blood compartments with
hydrogen peroxide; the remaining 10 centers (including the
two centers where patients continued to experience AARs with
reprocessed dialyzers) modified other dialyzer reprocessing
practices. No changes were made in the use of the heparin
product.
Reported by: GB Miller, Jr, MD, State Epidemiologist,
Virginia Dept of Health. J Wilber, MD, Acting State
Epidemiologist, Georgia Dept of Human Resources. Office of
Compliance, Center for Devices and Radiologic Health, Food
and Drug Administration. Hospital Infections Program, Center
for Infectious Diseases, CDC.
Editorial Note
Editorial Note: In the United States, reuse of disposable
hemodialyzers for the same patient is a common practice:
from 1977 through 1988, the proportion of centers that
reused dialyzers increased from 18% to 68% (2). Reprocessed
dialyzers have long been associated with outbreaks of
infection with a variety of microorganisms and with higher
incidence of pyrogenic reaction than have first-use
dialyzers (3-5); however, clusters of AARs associated with
reprocessed dialyzers had not been previously described.
Anaphylactic-like reactions in some patients undergoing
hemodialysis with first use of a dialyzer have been
associated with different dialyzer membranes and residual
amounts of ethylene oxide (6,7). Although the clinical
manifestations of patients with AARs associated with
reprocessed dialyzers are similar to those described for the
"first use syndrome," an allergenic substance and the
immunologic mechanism causing clusters of AARs with
reprocessed dialyzers has not been defined. AARs associated
with hemodialysis should be reported by physicians through
state health departments to the Epidemiology Branch,
Hospital Infections Program, Center for Infectious Diseases,
CDC; telephone (404) 639-3407.
Alter MJ, Favero MS, Moyer LA, Miller JK, Bland LA.
National surveillance of dialysis-associated diseases in the
United States, 1988. ASAIO Trans 1990;36:107-18.
Alter MJ, Favero MS, Miller JK, Coleman PJ, Bland LA.
Reuse of hemodialyzers: results of nationwide surveillance
for adverse effects. JAMA 1988;260:2073-6.
CDC. Bacteremia associated with reuse of disposable
hollow-fiber hemodialyzers. MMWR 1986;35:417-8.
Lowry PW, Beck-Sague CM, Bland LA, et al. Mycobacterium
chelonae infection among patients receiving high-flux
dialysis in a hemodialysis clinic in California. J Infect
Dis 1990;161:85-90.
Ward RA, Feldhoff PW, Klein E. Role of dialyzer
contaminants in the allergic epiphenomena of hemodialysis.
Artif Organs 1984;8:338-45.
Dolovich J, Marshall C, Smith EKM, et al. Allergy to
ethylene oxide in chronic hemodialysis patients. Artif
Organs 1984;8:334-7.
Defined as two or more of the following symptoms in a
hemodialysis patient: 1) generalized sensation of warmth; 2)
numbness or tingling of the extremities; 3) swelling or
fullness in the mouth or throat; and 4) shortness of breath,
audible wheezing, and/or chest tightness.
** Defined as two or more patients experiencing AARs within
10 minutes of initiating a hemodialysis treatment with a
reprocessed dialyzer in a hemodialysis center.
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