Journal Article

Multistate Outbreak of <i>Pseudomonas fluorescens</i> Bloodstream Infection after Exposure to Contaminated Heparinized Saline Flush Prepared by a Compounding Pharmacy

Mark D. Gershman, Donald J. Kennedy, Judith Noble-Wang, Curi Kim, Jessica Gullion, Marilyn Kacica, Bette Jensen, Neil Pascoe, Lisa Saiman, Jean McHale, Melinda Wilkins, Dianna Schoonmaker-Bopp, Joshua Clayton, Matthew Arduino and Arjun Srinivasan

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 47, issue 11, pages 1372-1379
Published in print December 2008 | ISSN: 1058-4838
Published online December 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/592968
Multistate Outbreak of Pseudomonas fluorescens Bloodstream Infection after Exposure to Contaminated Heparinized Saline Flush Prepared by a Compounding Pharmacy

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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.

Journal Article.  4172 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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