OUTBREAK OF STERILE PERITONITIS AMONG CONTINUOUS CYCLING PERITONEAL-DIALYSIS PATIENTS

Background. Approximately 30,000 patients receive peritoneal dialysis in the United States. In August 1996, several dialysis centers from di fferent states reported sterile peritonitis among CCPD patients using sterile peritoneal dialysis solution (PDS) from a single manufacturer. The manufacturer recalled 53 lots of PDS that had passed established industry guidelines and Food and Drug Administration (FDA) approved qu ality control tests [including endotoxin levels <0.5 endotoxin units ( EU)/ml], but had pre-sterilization bacterial colony counts >1 cfu/ml. Methods. At one outpatient dialysis center, Hospital of the University of Pennsylvania (HUP), we conducted a retrospective cohort study of a ll CCPD patients treated during July 15 to August 30, 1996. A case-pat ient was defined as any HUP patient with culture-negative peritoneal f luid with a white blood cell count >100/mm(3), cloudy peritoneal fluid , and/or abdominal pain. PDS and tubing were cultured for bacteria and assayed for endotoxin. Results. Overall, 14 of 28 patients had steril e peritonitis. The only risk factor identified was exposure to greater than or equal to 1 lot of recalled PDS (14 of 22 vs. 0/6, P = 0.02); the more recalled lots received, the higher the attack rate (P = 0.000 1). Five of 47 PDS bags had detectable endotoxin; recalled lots were m ore likely to have measurable endotoxin than nonrecalled lots (5/19 vs . 0/17, P = 0.05). When case-patients resumed CCPD using PDS from non recalled lots, no further cases were reported. Conclusions. Our result s suggest that this outbreak was caused by intrinsic PDS contamination with endotoxin. Pre-sterilization colony counts may be an important q uality control indicator for CCPD fluids in conjunction with endotoxin levels.