A multistate investigation of health care–associated Burkholderia cepacia complex infections related to liquid docusate sodium contamination, January-October 2016

Publication date: Available online 9 January 2018
Source:American Journal of Infection Control
Author(s): Janet Glowicz, Matthew Crist, Carolyn Gould, Heather Moulton-Meissner, Judith Noble-Wang, Tom J.B. de Man, K. Allison Perry, Zachary Miller, William C. Yang, Stephen Langille, Jessica Ross, Bobbiejean Garcia, Janice Kim, Erin Epson, Stephanie Black, Massimo Pacilli, John J. LiPuma, Ryan Fagan
BackgroundOutbreaks of health care–associated infections (HAIs) caused by Burkholderia cepacia complex (Bcc) have been associated with medical devices and water-based products. Water is the most common raw ingredient in nonsterile liquid drugs, and the significance of organisms recovered from microbiologic testing during manufacturing is assessed using a risk-based approach. This incident demonstrates that lapses in manufacturing practices and quality control of nonsterile liquid drugs can have serious unintended consequences.MethodsAn epidemiologic and laboratory investigation of clusters of Bcc HAIs that occurred among critically ill, hospitalized, adult and pediatric patients was performed between January 1, 2016, and October 31, 2016.ResultsOne hundred and eight case patients with Bcc infections at a variety of body sites were identified in 12 states. Two distinct strains of Bcc were obtained from patient clinical cultures. These strains were found to be indistinguishable or closely related to 2 strains of Bcc obtained from cultures of water used in the production of liquid docusate, and product that had been released to the market by manufacturer X.ConclusionsThis investigation highlights the ability of bacteria present in nonsterile, liquid drugs to cause infections or colonization among susceptible patients. Prompt reporting and thorough investigation of potentially related infections may assist public health officials in identifying and removing contaminated products from the market when lapses in manufacturing occur.



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