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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.

References

  1. CDC. Acute allergic reactions associated with reprocessed hemodialyzers--Virginia, 1989. MMWR 1989;38:873-4.

  2. 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.

  3. 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.

  4. CDC. Bacteremia associated with reuse of disposable hollow-fiber hemodialyzers. MMWR 1986;35:417-8.

  5. 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.

  6. Ward RA, Feldhoff PW, Klein E. Role of dialyzer contaminants in the allergic epiphenomena of hemodialysis. Artif Organs 1984;8:338-45.

  7. 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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