HDCN Article Review/Hyperlink

NY State Health Department

Sterile peritonitis outbreaks among peritoneal dialysis patients associated with possibly contaminated commercial dialysate. New York.

NY Health Dept Memorandum (Aug) :8/16/96 1996

This was communicated via the CDC to NEPHROL, and is being reprinted on HDCN.

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 in peritonitis.

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 U.S.A., Inc.

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).