title: An outbreak of Burkholderia cepacia complex associated with intrinsically contaminated nasal spray.
abstract: OBJECTIVE
  To determine the source of Burkholderia cepacia complex associated with a hospital outbreak and describe the measures taken to identify and confirm the source.
  
  
  METHODS
  A 250-bed, tertiary care pediatric hospital in Denver, Colorado.
  
  
  METHODS
  An epidemiologic investigation was used to identify possible causes for an apparent outbreak of B. cepacia complex in pediatric patients who had new positive cultures with this organism from December 2003 to February 2004. Chart review, microbiology reports, surgical records, site visits, literature review, staff interviews, and cultures of common products and equipment were performed to determine a source of contamination. Random amplified polymorphic DNA and pulsed-field gel electrophoresis typing, performed by 2 independent laboratories, were used for molecular typing of patient and source isolates.
  
  
  RESULTS
  Five pediatric patients had new positive B. cepacia complex cultures from either the sinus or the respiratory tract, and all 5 patients had prior exposure to 0.05% oxymetazoline hydrochloride Major Twice-A-Day 12-hour nasal spray (Proforma, Miami, FL). Four of the 5 patients had isolates that were identical to the B. cepacia complex isolates recovered from the unopened Twice-A-Day 12-hour nasal spray.
  
  
  CONCLUSIONS
  Intrinsic contamination of Major Twice-A-Day 12-hour nasal spray with B. cepacia complex resulted in nosocomial transmission to 4 patients at our facility and resulted in a voluntary product recall by the manufacturer. B. cepacia complex species are common contaminants of an increasing variety of nonsterile medical products. Enhanced culture techniques may be useful in evaluating possible product contamination, suggesting additional measures that should be considered to assure the safety of products that may be used in high-risk patients.
authors.affiliation: The Children's Hospital, Denver, Colorado 80045, USA. dolan.susan@tchden.org
authors.forename: Susan A
authors.initials: SA
authors.lastname: Dolan
authors.forename: Elaine
authors.initials: E
authors.lastname: Dowell
authors.forename: John J
authors.initials: JJ
authors.lastname: LiPuma
authors.forename: Sondra
authors.initials: S
authors.lastname: Valdez
authors.forename: Kenny
authors.initials: K
authors.lastname: Chan
authors.forename: John F
authors.initials: JF
authors.lastname: James
mesh_terms: D015373:Bacterial Typing Techniques; D019121:Burkholderia Infections / Q000453:epidemiology* / Q000209:etiology; D042602:Burkholderia cepacia complex / Q000145:classification / Q000302:isolation & purification*; D003120:Colorado; D003428:Cross Infection / Q000453:epidemiology* / Q000209:etiology / Q000382:microbiology; D004196:Disease Outbreaks; D004340:Drug Contamination; D006776:Hospitals, Pediatric; D006801:Humans; D017053:Infection Control / Q000379:methods*; D014663:Nasal Decongestants / Q000627:therapeutic use; D059085:Nasal Sprays; D010109:Oxymetazoline / Q000627:therapeutic use
chemical_list: D014663:Nasal Decongestants; D059085:Nasal Sprays; D010109:Oxymetazoline