Burkholderia stabilis outbreak associated with contaminated commercially-available washing gloves, Switzerland, May 2015 to August 2016

Abstract

We describe an outbreak of Burkholderia stabilis associated with contaminated washing gloves, a commercially available Class I medical device. Triggered by an increase in Burkholderia cepacia complex (BCC) bacteremias and the detection of BCC in unopened packages of washing gloves, an ad hoc national outbreak committee comprising representatives of a public health organisation, a regulatory agency, and an expert association convened and commissioned an outbreak investigation. The investigation included retrospective case finding across Switzerland and whole genome sequencing (WGS) of isolates from cases and gloves. The investigation revealed that BCC were detected in clinical samples of 46 cases aged 17 to 91 years (33% females) from nine institutions between May 2015 and August 2016. Twenty-two isolates from case patients and 16 from washing gloves underwent WGS. All available outbreak isolates clustered within a span of < 19 differing alleles, while 13 unrelated clinical isolates differed by > 1,500 alleles. This BCC outbreak was rapidly identified, communicated, investigated and halted by an ad hoc collaboration of multiple stakeholders. WGS served as useful tool for confirming the source of the outbreak. This outbreak also highlights current regulatory limitations regarding Class I medical devices and the usefulness of a nationally coordinated outbreak response.

Keywords: Burkholderia cepacia complex; Burkholderia stabilis; medical device, whole genome sequencing; nationwide; outbreak.

Figure 1

Diagnosis of cases with Burkholderia cepacia complex associated with contaminated Sinaqua Dermal Gloves by date of detection and type of infection or colonisation, Switzerland, May 2015–October 2016 (n = 46 outbreak cases and 1 ‘post-outbreak’ case^a)

Figure 2

Minimal spanning tree based on cgMLST allelic differences of outbreak and unrelated Burkholderia strains from patients and gloves, Switzerland, March 2016–October 2016