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Enterobacter cloacae bloodstream infections traced to contaminated human albumin
S A Wang1, J I Tokars, P J Bianchine
1Hospital Infections Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. sjw8@cdc.gov
Abstract:
In August 1996, a patient in Kansas developed an Enterobacter cloacae bloodstream infection (BSI) shortly after receiving Albuminar, a brand of human albumin. Albuminar contamination was suspected. A case-control study of patients with primary gram-negative bacterial BSIs showed that patients with E. cloacae BSIs were significantly more likely than patients with non-E. cloacae gram-negative BSIs to have received Albuminar within 3 days of developing their BSIs (3 of 5 vs. 0 of 9; OR, undefined; P=.03). The E. cloacae isolate from the Kansas patient was found by pulsed-field gel electrophoresis to be identical to the isolate from the patient's Albuminar vial, to isolates from 2 previously unopened Albuminar vials, and to an isolate from a Wisconsin patient who had received Albuminar. A worldwide recall of approximately 116,000 Albuminar vials took place. This multistate outbreak was detected because of clinical astuteness and prompt reporting. Combined epidemiological and laboratory approaches are valuable when investigating potentially contaminated blood components and plasma derivatives.
Insights
A multistate outbreak of Enterobacter cloacae bloodstream infections was linked to contaminated Albuminar, a human albumin product. Prompt reporting and combined lab/epidemiological methods enabled detection and a global product recall.
Area of Science:
- Infectious Diseases
- Epidemiology
- Microbiology
Background:
- Human albumin products are critical for treating various medical conditions.
- Bloodstream infections (BSIs) pose significant risks, especially in hospital settings.
- Contamination of plasma-derived products can lead to widespread outbreaks.
Observation:
- A cluster of Enterobacter cloacae BSIs emerged in 1996, with initial cases linked to Albuminar administration.
- A case-control study revealed a strong association between E. cloacae BSIs and recent Albuminar use.
- Molecular subtyping (pulsed-field gel electrophoresis) confirmed the identity of E. cloacae isolates across multiple patients and product vials.
Findings:
- Albuminar was identified as the source of a multistate E. cloacae outbreak.
- The investigation successfully linked clinical cases to contaminated product lots.
- A significant association was found between E. cloacae BSIs and Albuminar exposure (P=.03).
Implications:
- The findings underscore the importance of vigilant surveillance for healthcare-associated infections.
- Combined epidemiological and laboratory investigations are crucial for identifying contaminated biological products.
- This outbreak led to a worldwide recall of approximately 116,000 Albuminar vials, preventing further infections.
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