BACKGROUND: Burkholderia cepacia complex (Bcc) is an emerging cause of healthcare-associated outbreaks often due to contamination of medical products. In May 2016, hospitals in two states notified public health authorities of clusters of suspected healthcare-associated Bcc infections among non-cystic fibrosis patients in intensive care units (ICUs). Molecular analysis identified a previously undescribed Bcc species and the isolates were indistinguishable across facilities in separate regions of the country, suggesting contamination of a common product as an outbreak source.
METHODS: We sought to identify common exposures including devices, medications, and oral and skin care products. A national call for clusters of Bcc in non-cystic fibrosis patients was issued to assist case finding. A confirmed case was the first clinical culture on or after 1/1/2016 of Bcc from a hospitalized patient matching an outbreak strain by molecular typing. A suspect case was a culture yielding Bcc with unknown strain type from a patient in a facility with a confirmed case; once the source was identified, this was expanded to include patients with unknown Bcc strain exposed to the implicated product. Products were cultured for presence of Bcc and isolates were compared by pulsed-field gel electrophoresis (PFGE). National drug codes were collected from medical records to identify medication manufacturers.
RESULTS: Two distinct PFGE patterns of Bcc, labeled Pattern A and Pattern B, were identified from multiple facilities. Sixty-two confirmed cases (48 [77.4%] Pattern A, 14 [22.6%] Pattern B) and 46 suspect cases were identified in 11 states. Fifty of 62 (80.6%) confirmed cases had a positive respiratory culture; however, 11 (17.7%) had a primary or secondary Bcc bloodstream infection. Unopened oral liquid docusate from one facility tested positive for Bcc. In response CDC issued a nationwide health alert recommending facilities immediately suspend use of liquid docusate. Subsequently, docusate products and a water sample from the docusate production line at Manufacturer X grew Bcc including product isolates indistinguishable from clinical isolates with Patterns A and B. Forty-seven (97.9%) Pattern A and 10 (71.4%) Pattern B cases had documented exposure to liquid docusate from Manufacturer X. The manufacturer issued a voluntary recall of liquid docusate, which was later extended to all their manufactured liquid products.
CONCLUSIONS: Epidemiologic and laboratory evidence indicated this large multi-state outbreak of Bcc among susceptible ICU patients was due to contamination of a non-sterile oral liquid docusate product. This investigation demonstrates the importance of timely reporting of unusual clusters of illness and coordinated public health investigation.