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Surveillance and outbreak report Open Access
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Abstract

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.

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/content/10.2807/1560-7917.ES.2017.22.49.17-00213
2017-12-07
2017-12-11
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2017.22.49.17-00213
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References

  1. European Commission (EC). Medical Devices: Guidance document. Classification of medical devices. Guidelines relating to the application of the Council Directive 93/42/EEC on medical devices. MEDDEV 2. 4/1 Rev. 9. Luxembourg: EC; June 2010. [Accessed 16 Sep 2016]. Available from: http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf
  2. The Swiss Federal Council. Medical Devices Ordinance (MedDO) of 17 October 2001. Bern; the Swiss Federal Council; 1 Jan 2002. [Accessed 12 Dec 2016]. Available from: https://www.admin.ch/opc/en/classified-compilation/19995459/index.html
  3. European Commission. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Luxembourg: Publications Office of the European Union. L169. 12 Jul 1993. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
  4. European Commission. The ‘Blue Guide’ on the implementation of EU products rules 2016. Luxembourg: Publications Office of the European Union. C272. 26 Jul 2016. Available from: http://ec.europa.eu/DocsRoom/documents/12661/attachments/1/translations/en/renditions/native
  5. Iversen BG, Eriksen HM, G, Hagestad K, Jacobsen T, Engeset E, et al. Pseudomonas aeruginosa contamination of mouth swabs during production causing a major outbreak. Ann Clin Microbiol Antimicrob. 2007;6(1):3.  https://doi.org/10.1186/1476-0711-6-3  PMID: 17355630 
  6. Martin M, Christiansen B, Caspari G, Hogardt M, von Thomsen AJ, Ott E, et al. Hospital-wide outbreak of Burkholderia contaminans caused by prefabricated moist washcloths. J Hosp Infect. 2011;77(3):267-70.  https://doi.org/10.1016/j.jhin.2010.10.004  PMID: 21216034 
  7. Horsley A, Jones AM, Lord R. Antibiotic treatment for Burkholderia cepacia complex in people with cystic fibrosis experiencing a pulmonary exacerbation. Cochrane Database Syst Rev. 2016; (1):CD009529. PMID: 26789750 
  8. Mangram A, Jarvis WR. Nosocomial Burkholderia cepacia outbreaks and pseudo-outbreaks. Infect Control Hosp Epidemiol. 1996;17(11):718-20.  https://doi.org/10.2307/30141542  PMID: 8934237 
  9. Vonberg RP, Weitzel-Kage D, Behnke M, Gastmeier P. Worldwide Outbreak Database: the largest collection of nosocomial outbreaks. Infection. 2011;39(1):29-34.  https://doi.org/10.1007/s15010-010-0064-6  PMID: 21153042 
  10. Rutala WA, Weber DJ, Thomann CA, John JF, Saviteer SM, Sarubbi FA. An outbreak of Pseudomonas cepacia bacteremia associated with a contaminated intra-aortic balloon pump. J Thorac Cardiovasc Surg. 1988;96(1):157-61. PMID: 3386290 
  11. Nannini EC, Ponessa A, Muratori R, Marchiaro P, Ballerini V, Flynn L, et al. Polyclonal outbreak of bacteremia caused by Burkholderia cepacia complex and the presumptive role of ultrasound gel. Braz J Infect Dis. 2015;19(5):543-5.  https://doi.org/10.1016/j.bjid.2015.06.009  PMID: 26322722 
  12. Lucero CA, Cohen AL, Trevino I, Rupp AH, Harris M, Forkan-Kelly S, et al. Outbreak of Burkholderia cepacia complex among ventilated pediatric patients linked to hospital sinks. Am J Infect Control. 2011;39(9):775-8.  https://doi.org/10.1016/j.ajic.2010.12.005  PMID: 21664002 
  13. Magalhães M, Doherty C, Govan JR, Vandamme P. Polyclonal outbreak of Burkholderia cepacia complex bacteraemia in haemodialysis patients. J Hosp Infect. 2003;54(2):120-3.  https://doi.org/10.1016/S0195-6701(03)00118-X  PMID: 12818585 
  14. Balkhy HH, Cunningham G, Francis C, Almuneef MA, Stevens G, Akkad N, et al. A National Guard outbreak of Burkholderia cepacia infection and colonization secondary to intrinsic contamination of albuterol nebulization solution. Am J Infect Control. 2005;33(3):182-8.  https://doi.org/10.1016/j.ajic.2005.01.001  PMID: 15798674 
  15. Estivariz CF, Bhatti LI, Pati R, Jensen B, Arduino MJ, Jernigan D, et al. An outbreak of Burkholderia cepacia associated with contamination of albuterol and nasal spray. Chest. 2006;130(5):1346-53.  https://doi.org/10.1378/chest.130.5.1346  PMID: 17099009 
  16. Ghazal SS, Al-Mudaimeegh K, Al Fakihi EM, Asery AT. Outbreak of Burkholderia cepacia bacteremia in immunocompetent children caused by contaminated nebulized sulbutamol in Saudi Arabia. Am J Infect Control. 2006;34(6):394-8.  https://doi.org/10.1016/j.ajic.2006.03.003  PMID: 16877110 
  17. De Smet B, Veng C, Kruy L, Kham C, van Griensven J, Peeters C, et al. Outbreak of Burkholderia cepacia bloodstream infections traced to the use of Ringer lactate solution as multiple-dose vial for catheter flushing, Phnom Penh, Cambodia. Clin Microbiol Infect. 2013;19(9):832-7.  https://doi.org/10.1111/1469-0691.12047  PMID: 23173820 
  18. Fernández C, Wilhelmi I, Andradas E, Gaspar C, Gomez J, Romero J, et al. Nosocomial outbreak of Burkholderia pickettii infection due to a manufactured intravenous product used in three hospitals. Clin Infect Dis. 1996;22(6):1092-5.  https://doi.org/10.1093/clinids/22.6.1092  PMID: 8783718 
  19. Moehring RW, Lewis SS, Isaacs PJ, Schell WA, Thomann WR, Althaus MM, et al. Outbreak of bacteremia due to Burkholderia contaminans linked to intravenous fentanyl from an institutional compounding pharmacy. JAMA Intern Med. 2014;174(4):606-12.  https://doi.org/10.1001/jamainternmed.2013.13768  PMID: 24493147 
  20. Souza Dias MB, Cavassin LG, Stempliuk V, Xavier LS, Lobo RD, Sampaio JL, et al. Multi-institutional outbreak of Burkholderia cepacia complex associated with contaminated mannitol solution prepared in compounding pharmacy. Am J Infect Control. 2013;41(11):1038-42.  https://doi.org/10.1016/j.ajic.2013.01.033  PMID: 23663863 
  21. Zorrilla-Vaca A, Arevalo JJ, Escandón-Vargas K, Soltanifar D, Mirski MA. Infectious Disease Risk Associated with Contaminated Propofol Anesthesia, 1989-2014(1). Emerg Infect Dis. 2016;22(6):981-92.  https://doi.org/10.3201/eid2206.150376  PMID: 27192163 
  22. Ko S, An HS, Bang JH, Park SW. An outbreak of Burkholderia cepacia complex pseudobacteremia associated with intrinsically contaminated commercial 0.5% chlorhexidine solution. Am J Infect Control. 2015;43(3):266-8.  https://doi.org/10.1016/j.ajic.2014.11.010  PMID: 25557770 
  23. Lee S, Han SW, Kim G, Song DY, Lee JC, Kwon KT. An outbreak of Burkholderia cenocepacia associated with contaminated chlorhexidine solutions prepared in the hospital. Am J Infect Control. 2013;41(9):e93-6.  https://doi.org/10.1016/j.ajic.2013.01.024  PMID: 23608047 
  24. Romero-Gómez MP, Quiles-Melero MI, Peña García P, Gutiérrez Altes A, García de Miguel MA, Jiménez C, et al. Outbreak of Burkholderia cepacia bacteremia caused by contaminated chlorhexidine in a hemodialysis unit. Infect Control Hosp Epidemiol. 2008;29(4):377-8.  https://doi.org/10.1086/529032  PMID: 18462153 
  25. Ángeles-Garay U, Zacate-Palacios Y, López-Herrera JR, Hernández-Sánchez EA, Silva-Sánchez J, Ascencio-Montiel IdeJ. [Hospital outbreak of urinary tract infections by lubricant gel contaminated with Burkholderia cepacia]. Rev Med Inst Mex Seguro Soc. 2012;50(6):615-22. PMID: 23331747 
  26. Centers for Disease Control and Prevention (CDC). Nosocomial Burkholderia cepacia infection and colonization associated with intrinsically contaminated mouthwash--Arizona, 1998. MMWR Morb Mortal Wkly Rep. 1998;47(43):926-8. PMID: 9822365 
  27. Matrician L, Ange G, Burns S, Fanning WL, Kioski C, Cage GD, et al. Outbreak of nosocomial Burkholderia cepacia infection and colonization associated with intrinsically contaminated mouthwash. Infect Control Hosp Epidemiol. 2000;21(11):739-41.  https://doi.org/10.1086/501719  PMID: 11089663 
  28. Molina-Cabrillana J, Bolaños-Rivero M, Alvarez-León EE, Martín Sánchez AM, Sánchez-Palacios M, Alvarez D, et al. Intrinsically contaminated alcohol-free mouthwash implicated in a nosocomial outbreak of Burkholderia cepacia colonization and infection. Infect Control Hosp Epidemiol. 2006;27(11):1281-2.  https://doi.org/10.1086/508845  PMID: 17080395 
  29. Kutty PK, Moody B, Gullion JS, Zervos M, Ajluni M, Washburn R, et al. Multistate outbreak of Burkholderia cenocepacia colonization and infection associated with the use of intrinsically contaminated alcohol-free mouthwash. Chest. 2007;132(6):1825-31.  https://doi.org/10.1378/chest.07-1545  PMID: 17925414 
  30. Martin M, Winterfeld I, Kramme E, Ewert I, Sedemund-Adib B, Mattner F. Ausbruch mit Burkholderia-cepacia-Komplex durch kontaminierte Mundspüllösung. [Outbreak of Burkholderia cepacia complex caused by contaminated alcohol-free mouthwash]. Anaesthesist. 2012;61(1):25-9. German  https://doi.org/10.1007/s00101-011-1954-4  PMID: 22273822 
  31. Marquez L, Jones KN, Whaley EM, Koy TH, Revell PA, Taylor RS, et al. An Outbreak of Burkholderia cepacia Complex Infections Associated with Contaminated Liquid Docusate. Infect Control Hosp Epidemiol. 2017;38(5):567-73.  https://doi.org/10.1017/ice.2017.11  PMID: 28166854 
  32. Alvarez-Lerma F, Maull E, Terradas R, Segura C, Planells I, Coll P, et al. Moisturizing body milk as a reservoir of Burkholderia cepacia: outbreak of nosocomial infection in a multidisciplinary intensive care unit. Crit Care. 2008;12(1):R10.  https://doi.org/10.1186/cc6778  PMID: 18237375 
  33. Wiener-Well Y, Segonds C, Mazuz B, Kopuit P, Assous MV. Successful outbreak investigation of Burkholderia cepacia complex bacteremia in intensive care patients. Am J Infect Control. 2014;42(5):580-1.  https://doi.org/10.1016/j.ajic.2013.12.015  PMID: 24655899 
  34. Lo Cascio G, Bonora MG, Zorzi A, Mortani E, Tessitore N, Loschiavo C, et al. A napkin-associated outbreak of Burkholderia cenocepacia bacteraemia in haemodialysis patients. J Hosp Infect. 2006;64(1):56-62.  https://doi.org/10.1016/j.jhin.2006.04.010  PMID: 16859809 
  35. Swiss Centre for Antibiotic resistance. Bern, Switzerland. [Accessed 12 Dec 2016]. Available from: http://anresis.ch/
  36. Kronenberg A, Hilty M, Endimiani A, Muhlemann K. Temporal trends of extended-spectrum cephalosporin-resistant Escherichia coli and Klebsiella pneumoniae isolates in in- and outpatients in Switzerland, 2004 to 2011. Euro Surveill. 2013;18(21):20484. PMID: 23725981 
  37. Universitätsklinik für Infektiologie. Supplementary Material. Bern: Universitätsklinik für Infektiologie. 3 Jul 2017. Available from: http://www.infektiologie.insel.ch/index.php?id=26760
  38. Daligault HE, Davenport KW, Minogue TD, Bishop-Lilly KA, Broomall SM, Bruce DC, et al. Whole-genome assemblies of 56 burkholderia species. Genome Announc. 2014;2(6):e01106-14.  https://doi.org/10.1128/genomeA.01106-14  PMID: 25414490 
  39. Seemann T. Prokka: rapid prokaryotic genome annotation. Bioinformatics. 2014;30(14):2068-9.  https://doi.org/10.1093/bioinformatics/btu153  PMID: 24642063 
  40. Altschul SF, Gish W, Miller W, Myers EW, Lipman DJ. Basic local alignment search tool. J Mol Biol. 1990;215(3):403-10.  https://doi.org/10.1016/S0022-2836(05)80360-2  PMID: 2231712 
  41. Jünemann S, Sedlazeck FJ, Prior K, Albersmeier A, John U, Kalinowski J, et al. Updating benchtop sequencing performance comparison. Nat Biotechnol. 2013;31(4):294-6.  https://doi.org/10.1038/nbt.2522  PMID: 23563421 
  42. Bugrysheva JV, Cherney B, Sue D, Conley AB, Rowe LA, Knipe KM, et al. Complete Genome Sequences for Three Chromosomes of the Burkholderia stabilis Type Strain (ATCC BAA-67). Genome Announc. 2016;4(6):e01294-16.  https://doi.org/10.1128/genomeA.01294-16  PMID: 27856590 
  43. NCBI Resource Coordinators. Database Resources of the National Center for Biotechnology Information. Nucleic Acids Res. 2017;45(D1):D12-7.  https://doi.org/10.1093/nar/gkw1071  PMID: 27899561 
  44. Depoorter E, Bull MJ, Peeters C, Coenye T, Vandamme P, Mahenthiralingam E. Burkholderia: an update on taxonomy and biotechnological potential as antibiotic producers. Appl Microbiol Biotechnol. 2016;100(12):5215-29.  https://doi.org/10.1007/s00253-016-7520-x  PMID: 27115756 
  45. Vandamme P, Peeters C. Time to revisit polyphasic taxonomy. Antonie van Leeuwenhoek. 2014;106(1):57-65.  https://doi.org/10.1007/s10482-014-0148-x  PMID: 24633913 
  46. The Swiss Federal Council. Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA) of 15 December 2000. Bern: the Swiss Federal Council; 1 Jan 2002. [Accessed 12 Dec 2016]. Available from: https://www.admin.ch/opc/en/classified-compilation/20002716/index.html
  47. European Commission (EC). Medical Devices: Guidance document. Guidelines on a medical devices vigilance system. MEDDEV 2.12-1 rev 8. Luxembourg: EC; January 2013. [Accessed 15 Jun 2017]. Available from: http://ec.europa.eu/DocsRoom/documents/15506/attachments/1/translations
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