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