Sommerstein Rami, Führer Urs, Lo Priore Elia, Casanova Carlo, Meinel Dominik M, Seth-Smith Helena Mb, Kronenberg Andreas, Koch Daniel, Senn Laurence, Widmer Andreas F, Egli Adrian, Marschall Jonas
Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.
These authors contributed equally to the manuscript.
Euro Surveill. 2017 Dec;22(49). doi: 10.2807/1560-7917.ES.2017.22.49.17-00213.
We describe an outbreak of associated with contaminated washing gloves, a commercially available Class I medical device. Triggered by an increase in 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.
我们描述了一起与受污染的洗涤手套相关的疫情,洗涤手套是一种市面上可买到的I类医疗器械。由复杂(BCC)菌血症增加以及在未开封的洗涤手套包装中检测到BCC引发,一个由公共卫生组织、监管机构和专家协会代表组成的临时全国疫情委员会召开会议并委托进行疫情调查。调查包括在瑞士进行回顾性病例查找以及对病例和手套分离株进行全基因组测序(WGS)。调查显示,在2015年5月至2016年8月期间,从9个机构的46例年龄在17至91岁(33%为女性)的临床样本中检测到了BCC。对22例病例患者的分离株和16例洗涤手套的分离株进行了WGS。所有可用的疫情分离株聚集在跨度小于19个不同等位基因范围内,而13个不相关的临床分离株相差超过1500个等位基因。通过多个利益相关者的临时合作,这起BCC疫情迅速得到识别、通报、调查并得到控制。WGS是确认疫情源头的有用工具。此次疫情还凸显了当前关于I类医疗器械的监管局限性以及全国协调疫情应对措施的有用性。