Janet Glowicz1, Matthew Crist2, Carolyn Gould2, Heather Moulton-Meissner3, Judith Noble-Wang3, Tom J B de Man3, K Allison Perry3, Zachary Miller4, William C Yang5, Stephen Langille5, Jessica Ross6, Bobbiejean Garcia6, Janice Kim7, Erin Epson7, Stephanie Black8, Massimo Pacilli8, John J LiPuma9, Ryan Fagan2. 1. Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA; Health Protection and Promotion Operational Unit, Northrop Grumman, Atlanta, GA. Electronic address: kvi1@cdc.gov. 2. Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA. 3. Clinical and Environmental Microbiology Branch, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA. 4. Office of Regulatory Affairs, Denver and San Francisco Laboratories, Food and Drug Administration, Silver Spring, MD. 5. Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD. 6. Texas Department of State Health Services, Austin, TX. 7. California Department of Public Health, Richmond, CA. 8. Chicago Department of Public Health, Chicago, IL. 9. Burkholderia cepacia Research Laboratory and Repository, Ann Arbor, MI.
Abstract
BACKGROUND: Outbreaks 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. METHODS: An 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. RESULTS: One 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. CONCLUSIONS: This 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.
BACKGROUND: Outbreaks 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. METHODS: An 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. RESULTS: One 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. CONCLUSIONS: This 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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