NY State Health Department
Sterile peritonitis outbreaks among peritoneal dialysis
patients associated with possibly contaminated commercial dialysate.
NY Health Dept Memorandum
(Aug) :8/16/96 1996
This was communicated via the CDC to NEPHROL, and is being reprinted on
As of August 14, 1996, eight dialysis centers in New York State have
reported outbreaks of culture negative peritonitis among home peritoneal
dialysis patients. All eight facilities report that patients were using
5 liter bags of Delflex brand dialysate manufactured by Fresenius U.S.A.,
Inc. of Walnut Creek, California. Tubing (Echo III) manufactured by the
same company is also common to the patients in the eight facilities.
Preliminary laboratory studies of the peritoneal fluid and dialysate
have not identified a specific microbiologic agent and further studies
are in progress. All cases have been reported among continuous cycling
peritoneal dialysis (CCPD) patients. None of the patients on continuous
ambulatory peritoneal dialysis (CAPD) have reported an increased incidence
New York State Department of Health staff are calling all 146 dialysis
centers in New York State to identify additional cases.
Although data is preliminary, multiple lot numbers of dialysate and
tubing appear to be involved. The New York State Department of Health
cannot make a definitive recommendation at this early stage in the
investigation as insufficient data exists. Future recommendations are
anticipated from U.S. Food and Drug Administration and/or Fresenius
Any state health departments becoming aware of similar clusters
should contact Dr. Gerry Tokars of the Hospital Infection Program at
the Centers for Disease Control and Prevention (CDC) at (404) 639-6418.
Questions regarding Fresenius products should be directed to Dr. Mark
Fow at the Food and Drug Administration (FDA) at (301) 443-4667.
Stan Kondrack/Dr. Helen Cicirello NYSDOH 518-473-4436
HDCN editor's note: Apparently some additional cases have been
reported in Pennsylvania as
well, as per a
News Report in the August 24 issue of The Lancet (you will need to
register with the Lancet before being able to access this).