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.
Highlights
Medical devices are defined as any instrument, apparatus, appliance, material or other article to be used on www.eurosurveillance.org human beings for diagnosis, prevention, monitoring or alleviation of disease
Neither age nor gender of the cases was reported by the Antibiotic resistance (Anresis) query
The number of B. cepacia isolates from sterile sites increased nonsignificantly (p = 0.38) from 0.8/month in 2015 to 2.2/month in the first six months of 2016
Summary
Medical devices are defined as any instrument, apparatus, appliance, material or other article to be used on www.eurosurveillance.org human beings for diagnosis, prevention, monitoring or alleviation of disease. In Europe, medical devices are classified by the potential risk they pose to the health of patients, users or third parties [1,2]. The underlying rationale for this risk-based system is to direct the most rigorous conformity assessment procedures to those products conferring the greatest risk [1,2]. I medical devices, e.g. non-sterile products that only come into contact with intact skin [1], represent the lowest risk category and conformity assessment is left to the responsibility of the manufacturer [3]. I device conforms with the Medical Devices Directive it can be placed on the market in the entire. A few outbreaks have been traced to Class I medical devices contaminated at the site of their production [5,6]
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