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Epidemiologic Notes and Reports Bacteremia Associated with Reuse Of Disposable Hollow-Fiber Hemodialyzers

Since May 6, 1986, CDC and the U.S. Food and Drug Administration (FDA) have received reports from four free-standing hemodialysis clinics of clusters of patients with gram-negative bacteremia. These patients were undergoing maintenance hemodialysis at clinics in which disposable hollow-fiber hemodialyzers were reused on the same patient after disinfection with a recently introduced chemical germicide, RenNew-D (manufactured by Alcide Corporation, Norwalk, Connecticut, and solely distributed by Cobe Laboratories, Inc., Lakewood, Colorado).

CDC and FDA have participated in investigations of these clusters at two of the four clinics. A total of nine patients at these two clinics met a case definition of intradialytic sepsis based on the following criteria: (1) absence of signs or symptoms of infection at the initiation of the dialysis session; (2) presence of one or more of the following signs or symptoms during the dialysis session: shaking chills, fever, hypotension, nausea, vomiting; and (3) growth of gram-negative microorganisms from blood cultures obtained during or following the dialysis session. Review of microbiologic records in these centers showed no clusters of gram-negative bacteremia during the preceding 6 months. All the patients were treated with parenteral antimicrobials and recovered without apparent sequelae. Microorganisms isolated from the blood cultures included Pseudomonas aeruginosa (five patients), P. maltophilia (three), Acinetobacter calcoaceticus (var. lwoffi) (three), P. putida (one), and Alcaligenes denitrificans (one). Three patients had two or more microorganisms isolated from their blood. These two hemodialysis clinics had been using RenNew-D for reprocessing of hemodialyzers for 6 weeks and 4 months, respectively, before the first documented case of bacteremia.

Microbiologic investigation of hemodialyzers at one of the four clinics showed bacterial contamination of the blood compartment in 10 of 20 hemodialyzers after reprocessing with RenNew-D during the week of June 9. For the 17 hemodialyzers for which the number of reuses was documented, the number of previous uses ranged from one to 50. Changes in the mixing and handling of RenNew-D were subsequently made by the staff at the hemodialysis clinic after consultation with representatives of the manufacturer and distributor of the product. Following these changes, cultures were performed of: (1) RenNew-D drained from stored reprocessed hemodialyzers; (2) saline that had been used to rinse the blood circuits, including the interiors of reprocessed hemodialyzers and other components of the blood circuits, before dialysis; and (3) blood obtained from the blood circuit during the patients' dialyses. Gram-negative microorganisms were identified in none of 137 samples of RenNew-D, in seven (6%) of 108 samples of the predialysis saline rinse, and in blood cultures from 11 (11%) of 102 patients.

It has not been determined why hemodialyzers showed evidence of contamination after reprocessing with RenNew-D. The manufacturer has initiated a voluntary recall of all lots of the product. Studies are in progress to evaluate the source and possible causes of these clusters. Reported by GT Flynn, Community Dialysis Svcs, Inglewood, SH Waterman, MD, Los Angeles County Health Dept, SB Werner, MD, California Dept of Health Svcs; TF Parker, MD, Dallas Kidney Disease Center, G Green, MD, CE Haley, MD, Dallas County Health Dept, CE Alexander, MD, State Epidemiologist, Texas Dept of Health; Center for Devices and Radiologic Health, US Food and Drug Administration; Hospital Infections Program, Center for Infectious Diseases, CDC.

Editorial Note

Editorial Note: The practice of disinfecting and reusing hemodialyzers labeled "for single use only" has been adopted by more than 50% of hemodialysis centers responding to surveys of dialysis-associated diseases (1). Bacterial contamination resulting in patient infections has previously been documented in hemodialyzers that were reprocessed with benzalkonium chloride (2,3) and 2% formaldehyde (4).

Until further information is available, CDC recommends that providers of hemodialysis services review their experience and assess the clinical safety of their hemodialysis practices. Evaluation of reuse programs should include active surveillance of hemodialysis patients for both infectious and noninfectious complications. Clinical, laboratory, and epidemiologic information about patients experiencing adverse reactions should be recorded in the patient's medical record, as well as in a log book, so that incidence rates of these complications can be determined. Additional studies of the functional and microbiologic quality of reprocessed hemodialyzers, as well as the factors affecting their clinical safety, are needed to formulate guidelines.

References

  1. Bland L, Alter M, Favero M, Carson L, Cusick L. Hemodialyzer reuse: practices in the United States and implication for infection control. Trans Am Soc Artificial Intern Organs 1985;31:556-9.

  2. Wagnild JP, McDonald P, Craig WA, et al. Pseudomonas aeruginosa bacteremia in a dialysis unit. II. Relationship to reuse of coils. Am J Med 1977;62:672-6.

  3. Kuehnel E, Lundh H. Outbreak of Pseudomonas cepacia bacteremia related to contaminated reused coils. Dialysis and Transplantation 1976;5:44-5, 48, 66.

  4. Bolan G, Reingold AL, Carson LA, et al. Infections with Mycobacterium chelonei in patients receiving dialysis and using processed hemodialyzers. J Infect Dis 1985;152:1013-9.



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