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Multistate Outbreak of Burkholderia cepacia Complex Bloodstream Infections After Exposure to Contaminated Saline
Richard B Brooks1,2, Patrick K Mitchell1,3, Jeffrey R Miller3,4
1Epidemic Intelligence Service, Division of Scientific Education and Professional Development, Centers for Disease Control and Prevention, Atlanta, Georgia.
Background:
Burkholderia cepacia complex (Bcc) has caused healthcare-associated outbreaks, often in association with contaminated products. The identification of 4 Bcc bloodstream infections in patients residing at a single skilled nursing facility (SNF) within 1 week led to an epidemiological investigation to identify additional cases and the outbreak source.
Methods:
A case was initially defined via a blood culture yielding Bcc in a SNF resident receiving intravenous therapy after 1 August 2016. Multistate notifications were issued to identify additional cases. Public health authorities performed site visits at facilities with cases to conduct chart reviews and identify possible sources. Pulsed-field gel electrophoresis (PFGE) was performed on isolates from cases and suspect products. Facilities involved in manufacturing suspect products were inspected to assess possible root causes.
Results:
An outbreak of 162 Bcc bloodstream infections across 59 nursing facilities in 5 states occurred during September 2016-January 2017. Isolates from patients and pre-filled saline flush syringes were closely related by PFGE, identifying contaminated flushes as the outbreak source and prompting a nationwide recall. Inspections of facilities at the saline flush manufacturer identified deficiencies that might have led to the failure to sterilize a specific case containing a partial lot of the product.
Conclusions:
Communication and coordination among key stakeholders, including healthcare facilities, public health authorities, and state and federal agencies, led to the rapid identification of an outbreak source and likely prevented many additional infections. Effective processes to ensure the sterilization of injectable products are essential to prevent similar outbreaks in the future.
Insights
A healthcare-associated outbreak of Burkholderia cepacia complex (Bcc) bloodstream infections was traced to contaminated saline flush syringes. This investigation highlights the critical need for robust sterilization processes in injectable product manufacturing to prevent future outbreaks.
Area of Science:
- Infectious Diseases
- Epidemiology
- Public Health
Background:
- The Burkholderia cepacia complex (Bcc) is a known cause of healthcare-associated infections, frequently linked to contaminated medical products.
- An initial cluster of four Bcc bloodstream infections in a skilled nursing facility (SNF) triggered an investigation into a potential outbreak and its source.
Purpose of the Study:
- To identify additional cases of Bcc bloodstream infections.
- To determine the source of the Bcc outbreak in SNF residents.
Main Methods:
- Case definition included Bcc identified in blood cultures of SNF residents receiving intravenous therapy post-August 2016.
- Multistate notifications and site visits were conducted to identify cases and potential sources.
- Pulsed-field gel electrophoresis (PFGE) was used to compare isolates from patients and suspect products, with manufacturing facility inspections to identify root causes.
Main Results:
- A large outbreak involved 162 Bcc bloodstream infections across 59 facilities in five states (September 2016-January 2017).
- PFGE analysis linked patient isolates to pre-filled saline flush syringes, identifying them as the outbreak source.
- Manufacturing facility inspections revealed sterilization failures in a specific product lot, leading to a nationwide recall.
Conclusions:
- Effective communication and collaboration among healthcare facilities, public health authorities, and regulatory agencies were crucial for rapid outbreak source identification and containment.
- Ensuring stringent sterilization protocols for injectable products is paramount to prevent future healthcare-associated Bcc outbreaks.
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