An outbreak of Burkholderia cepacia complex associated with an intrinsically contaminated nasal spray product

• Published in: American journal of infection control Vol. 33; no. 5; pp. e110 - e111
• Main Authors: Dolan, S., Dowell, E., Valdez, S., LiPuma, J., James, J.
• Format: Journal Article
• Language: English
• Published: Mosby, Inc 01.06.2005
• ISSN: 0196-6553; 1527-3296
• DOI: 10.1016/j.ajic.2005.04.136

OBJECTIVE: To determine the source of Burkholderia cepacia complex associated with an outbreak that occurred at a 250-bed, tertiary-care, pediatric hospital in Denver, Colorado, and describe the measures taken to identify and confirm the source. METHODS: An epidemiologic investigation was used to identify possible causes for Burkholderia cepacia in pediatric patients that had new positive cultures with this organism from December 2003 through February 2004. Chart review, organism reports, surgical records, site visits, literature review, staff interviews, and cultures of common products and equipment were performed to determine the source of contamination. Random primer PCR and pulsed-field gel electrophoresis (PFGE), performed by two independent laboratories, were used for molecular typing of patient and source isolates. RESULTS: Five pediatric patients had new positive Burkholderia cepacia cultures from either the sinus or respiratory tract. Four of the five patients had isolates that were identical to the Burkholderia cepacia isolates from a 12-hour nasal spray product. One of these patients was a cystic fibrosis patient who had never previously tested positive for this organism. One of the five patients had an isolate that was not identical to the nasal spray or the other four patient isolates. CONCLUSIONS: Intrinsic contamination of a nasal spray product (Twice-A-Day 12-hour Nasal Spray™) with Burkholderia cepacia resulted in nosocomial transmission to four patients at our facility, one of whom had cystic fibrosis. Notification of the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) of this confirmed outbreak resulted in a voluntary product recall. As a result, an investigation by the CDC was undertaken to determine the extent of this outbreak nationwide.