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Outbreak of sterile peritonitis among continuous cycling peritoneal dialysis patients.
- Source :
-
Kidney international [Kidney Int] 1998 Oct; Vol. 54 (4), pp. 1367-71. - Publication Year :
- 1998
-
Abstract
- 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.<br />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.<br />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.<br />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.
- Subjects :
- Adult
Ambulatory Care
Colony Count, Microbial
Dialysis Solutions chemistry
Dialysis Solutions standards
Drug Contamination
Drug and Narcotic Control
Endotoxins analysis
Female
Hospitals, University
Humans
Male
Middle Aged
Pennsylvania epidemiology
Peritonitis microbiology
Quality Control
Sterilization
United States epidemiology
Dialysis Solutions adverse effects
Disease Outbreaks
Peritoneal Dialysis, Continuous Ambulatory adverse effects
Peritonitis epidemiology
Peritonitis etiology
Subjects
Details
- Language :
- English
- ISSN :
- 0085-2538
- Volume :
- 54
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Kidney international
- Publication Type :
- Academic Journal
- Accession number :
- 9767557
- Full Text :
- https://doi.org/10.1046/j.1523-1755.1998.00110.x