Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy
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Mark D Gershman1, Donald J Kennedy, Judith Noble-Wang
1Epidemic Intelligence Service, National Center for Preparedness, Detection and Control of Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Background:
Pharmaceutical compounding, the manipulation of ingredients to create a customized medication, is a widespread practice. In January 2005, the Centers for Disease Control and Prevention was notified of 4 cases of Pseudomonas fluorescens bacteremia that were traced to contaminated heparinized saline intravenous flush syringes prepared as a compounded medical product.
Patients And Methods:
We reviewed medical records of symptomatic patients with P. fluorescens-positive cultures of blood specimens or sections of explanted catheters, reviewed the production process of syringes, performed syringe cultures, compared isolates by pulsed-field gel electrophoresis (PFGE), and examined catheters by scanning electron microscopy.
Results:
We identified 80 patients in 6 states with P. fluorescens-positive cultures during December 2004-March 2006. Sixty-four patients (80%) had received a diagnosis of cancer. Seventy-four (99%) of 75 patients for whom information about catheter type was available had long-term indwelling catheters. Thirty-three (41%) of 80 cases were diagnosed 84-421 days after the patient's last potential exposure to a contaminated flush (delayed-onset cases). Compared with patients with early infection onset, more patients with delayed infection onset had venous ports (100% versus 50%; P <.001). By PFGE, clinical isolates from 50 (98%) of 51 patients were related to isolates cultured from unopened syringes. Scanning electron microscopy of explanted catheters revealed biofilms containing organisms morphologically consistent with P. fluorescens.
Conclusion:
This outbreak underscores important challenges in ensuring the safety of compounded pharmaceuticals and demonstrates the potential for substantially delayed infections after exposures to contaminated infusates. Exposures to compounded products should be considered when investigating outbreaks. Patients exposed to contaminated infusates require careful follow-up, because infections can occur long after exposure.
Insights
A Pseudomonas fluorescens outbreak linked to compounded medications caused bacteremia in 80 patients, highlighting risks of delayed infections from contaminated intravenous products.
Area of Science:
- Infectious Disease Epidemiology
- Pharmaceutical Compounding Safety
- Microbial Contamination in Healthcare
Background:
- A 2005 outbreak involved Pseudomonas fluorescens bacteremia traced to compounded heparinized saline intravenous flush syringes.
- This incident raised concerns about the safety of pharmaceutical compounding practices.
Purpose of the Study:
- To investigate the scope and characteristics of a Pseudomonas fluorescens outbreak linked to compounded medications.
- To identify risk factors and understand the timeline of infections associated with contaminated intravenous products.
Main Methods:
- Retrospective review of medical records for symptomatic patients with P. fluorescens-positive cultures.
- Analysis of the compounding production process and microbial cultures of syringes.
- Molecular comparison of bacterial isolates using pulsed-field gel electrophoresis (PFGE) and scanning electron microscopy of catheters.
Main Results:
- Eighty patients across six states were identified with P. fluorescens-positive cultures between December 2004 and March 2006.
- A significant proportion of affected patients had cancer and long-term indwelling catheters.
- Delayed-onset infections, occurring months after exposure, were observed, with a higher incidence in patients with venous ports.
Conclusions:
- The outbreak highlighted critical challenges in ensuring the safety of compounded pharmaceuticals.
- Delayed infections following exposure to contaminated infusates are a significant concern.
- Healthcare providers should consider compounded product exposures in outbreak investigations and ensure careful patient follow-up due to the potential for late-onset infections.
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