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 different 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 quality 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 all CCPD patients treated during July 15 to August 30, 1996. A case-patient was defined as any HUP patient with culture-negative peritoneal fluid with a white blood cell count >100/mm3, 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 sterile peritonitis. The only risk factor identified was exposure to > or =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 = 0.0001). Five of 47 PDS bags had detectable endotoxin; recalled lots were more 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 results suggest that this outbreak was caused by intrinsic PDS contamination with endotoxin. Pre-sterilization colony counts may be an important quality control indicator for CCPD fluids in conjunction with endotoxin levels.
Mangram
A J
AJ
Hospital Infections Program, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. ajm7@cdc.gov
Archibald
L K
LK
Hupert
M
M
Tokars
J I
JI
Silver
L C
LC
Brennan
P
P
Arduino
M
M
Peterson
S
S
Parks
S
S
Raymond
A
A
McCullough
M
M
Jones
M
M
Wasserstein
A
A
Kobrin
S
S
Jarvis
W R
WR
D000328:Adult; D000553:Ambulatory Care; D015169:Colony Count, Microbial; D015314:Dialysis Solutions / Q000009:adverse effects* / Q000737:chemistry / Q000592:standards; D004196:Disease Outbreaks; D004340:Drug Contamination; D004335:Drug and Narcotic Control; D004731:Endotoxins / Q000032:analysis; D005260:Female; D006785:Hospitals, University; D006801:Humans; D008297:Male; D008875:Middle Aged; D010414:Pennsylvania / Q000453:epidemiology; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000009:adverse effects*; D010538:Peritonitis / Q000453:epidemiology* / Q000209:etiology* / Q000382:microbiology; D011786:Quality Control; D013242:Sterilization; D014481:United States / Q000453:epidemiology
D015314:Dialysis Solutions; D004731:Endotoxins