REFERENZE      

1

Acosta F, Perez-Lago L, Ruiz Serrano M, et al. Fast update of undetected Mycobacterium Chimaera infections to reveal unsuspected cases. J Hosp Infect. 2018;100:451-455. doi:10.1016/j.jhin.2018.08.018

2

Sax H, Bloemberg G, Hasse B, et al. Prolonged Outbreak of Mycobacterium Chimaera Infection After Open-Chest Heart Surgery. Clin Infect Dis. 2015;61:67-75. doi:10.1093/cid/civ198

3

Schreiber PW, Sax H. Mycobacterium Chimaera infections associated with heater – cooler units in cardiac surgery. Curr Opin Infect Dis. 2017;30(4):388-394.doi:10.1097/QCO.0000000000000385

4

Sousa S, Bandeira M, Carvalho PA, Duarte A, Jordao L. Nontuberculous mycobacteria pathogenesis and biofilm assembly. Int J Mycobacteriology. 2015;4(1):36-43.doi:10.1016/j.ijmyco.2014.11.065

5

27. Allen KB, Yuh DD, Schwartz SB, et al. Nontuberculous Mycobacterium Infections Associated With Heater-Cooler Devices. Ann Thorac Surg. 2017;104(4):1237-1242.doi:10.1016/j.athoracsur.2017.04.067

6

Schulze-Röbbecke R, Buchholtz K. Heat susceptibility of aquatic mycobacteria. Appl Environ Microbiol. 1992;58(6):1869-1873.http://www.ncbi.nlm.nih.gov/pubmed/1622262. Accessed May 10, 2019.

7

Falkinham J. Common Features of Opportunistic Premise Plumbing Pathogens. Int J Environ Res Public Health. 2015;12(5):4533-4545.doi:10.3390/ijerph120504533

8

Sommerstein R, Hasse B, Marschall J, et al. Global Health Estimate of Invasive Mycobacterium Chimaera Infections Associated with Heater – Cooler Devices in Cardiac Surgery. Emerg Infect Dis. 2018;24(3):1-3

9

Kanamori H, Weber DJ, Rutala WA. Healthcare-Associated Mycobacterium Chimaera Transmission and Infection Prevention Challenges : Role of Heater-Cooler Unitsas a Water Source in Cardiac Surgery. Clin Infect Dis. 2017;27514(3):343-346. doi:10.1093/cid/ciw755

10

Walker J, Moore G, Collins S, et al. Microbiological problems and biofilms associated with Mycobacterium Chimaera in heater - cooler units used for cardiopulmonary bypass. J Hosp Infect. 2017;96(3):209-220. doi:10.1016/j.jhin.2017.04.014

11

Chand M, Lamagni T, Kranzer K, et al. Insidious Risk of Severe Mycobacterium Chimaera Infection in Cardiac Surgery Patients. Clin Infect. 2017;64(3):335-342.doi:10.1093/cid/ciw754

12

Scriven JE, Scobie A, Verlander NQ, et al. Mycobacterium Chimaera infection following cardiac surgery in the United Kingdom: clinical features and outcome of the first30 cases. Clin Microbiol Infect. 2018;24(11):1164-1170. doi:10.1016/j.cmi.2018.04.027

13

Griffith DE, Aksamit T, Brown-elliott BA, et al. American Thoracic Society Documents An Official ATS / IDSA Statement : Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases. Am J Respir Crit Care Med. 2007;175:367-416. doi:10.1164/rccm.200604-571ST

14

Kasperbauer SH, Daley CL. Mycobacterium Chimaera Infections Related to the Heater-Cooler Unit Outbreak: A Guide to Diagnosis and Management. Clin Infect Dis.2018;68(7):1244-1250. doi:10.1093/cid/ciy789

15

Grubitzsch H, Christ T, Melzer C, Kastrup M, Treskatsch S, Konertz W. Surgery for prosthetic valve endocarditis: Associations between morbidity, mortality and costs.Interact Cardiovasc Thorac Surg. 2016;22(6):784-791. doi:10.1093/icvts/ivw035

16

57. Kuehn C, Graf K, Heuer W, et al. Economic implications of infections of implantable cardiac devices in a single institution. Eur J Cardiothoracic Surg.2010;37(4):875-879. doi:10.1016/j.ejcts.2009.10.018

17

Marra AR, Diekema DJ, Edmond MB. Mycobacterium chimaera Infections Associated With Contaminated Heater-Cooler Devices for Cardiac Surgery: Outbreak Management. Clin Infect Dis. 2017;65:669-674. doi:10.1093/cid/cix368.; *Schreiber PW, Kuster SP, Hasse B, et al.
Reemergence of Mycobacterium chimaera in Heater–Cooler Units despite Intensified Cleaning and Disinfection Protocol. Emerg Infect Dis. 2016;22(10):2-5.;

18

Martí MC, Bermejo BB, Gil LA. Infections with Mycobacterium Chimaera and open chest surgery. An unresolved problem. Med Clínica (English Ed. 2019:1-7.doi:10.1016/j.medcle.2019.02.006

19

Cappabianca G, Paparella D, Onofrio AD, et al. Mycobacterium Chimaera infections following cardiac surgery in Italy: results from a National Survey Endorsed by the Italian Society of Cardiac Surgery. J Cardiovasc Med. 2018;19:748-755. doi:10.2459/JCM.0000000000000717

20

Taylor RH, Falkinham JO, Norton CD, LeChevallier MW. Chlorine, Chloramine, Chlorine Dioxide, and Ozone Susceptibility of Mycobacterium avium. Appl Environ Microbiol. 2000;66(4):1702-1705. doi:10.1128/AEM.66.4.1702-1705.2000

21

Garvey MI, Ashford R, Bradley CW, et al. Decontamination of heater - cooler units associated with contamination by atypical mycobacteria. J Hosp Infect. 2016;93(3):229-234. doi:10.1016/j.jhin.2016.02.007

22

Barker TA, Dandekar U, Fraser N, et al. Minimising the risk of Mycobacterium Chimaera infection during cardiopulmonary bypass by the removal of heater-cooler units from the operating room. Perfusion. 2018;33(4):264-269. doi:10.1177/0267659117739103

23

European Centre for Disease Prevention and Control. RAPID RISK ASSESSMENT: European Centre for Disease Prevention and Control. Invasive Cardiovascular Infection by Mycobacterium Chimaera Associated with 3T Heater -Cooler System Used during Open-Heart Surgery – 18 November 2016.; 2016. https://ecdc.europa.eu/sites/portal/ files/media/en/publications/Publications/RRA-mycobacterium-chimaera-November-2016.pdf.

24

TV2. To danskere smittet med livsfarlig og sjælden bakterie - flere skal undersøges.http://nyheder.tv2.dk/lokalt/2019-07-11-to-danskeresmittet-med-livsfarlig-ogsjaelden- bakterie-flere-skal-undersoeges.

25

Bursle E, Playford EG, Coulter C, Griffin P. First Australian case of disseminated Mycobacterium Chimaera infection post-cardiothoracic surgery. Infect Dis Heal. 2017;22(1):1-5. doi:10.1016/j.idh.2017.01.003

26

DIREZIONE GENERALE DELLA PREVENZIONE SANITARIA. Operational Indications Concerning the Laboratory Aspects Concerning the Cases of Mycobacterium Chimaera Infection in Italy and Information Update Available. ITALY; 2019. http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2019&codLeg=68845&parte=1&serie=null.

27

Robert Koch Institut. Information on an international outbreak with non-tuberculous mycobacteria associated with temperature control devices during cardiac surgery.https://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Aufb_MedProd/Mycobacterium_chimaera.html. Published 2019.

28

Scriven JE, Scobie A, Verlander NQ, et al. Mycobacterium Chimaera infection following cardiac surgery in the United Kingdom: clinical features and outcome of the first 30 cases. Clin Microbiol Infect. 2018;24(11):1164-1170. doi:10.1016/j.cmi.2018.04.027

29

Chan T, Ling ML, Teng SY, Chiu KY, James EM. Microbiological monitoring of heater-cooler unit to keep free of Mycobacterium Chimaera infection. Perfu. 2019;34(1):9-14. doi:10.1177/0267659118787152

30

Zahreddine N, Tannous J, Kanafani Z, et al. Isolation of Nontuberculous Mycobacterium (NTM) from heater cooler devices, in a tertiary care center in Lebanon. Antimicrob Resist Infect Control. 2017;6(Abstracts from the 4th International Conference on Prevention & Infection Control (ICPIC 2017)):8-9.

31

Williamson D, Howden B, Stinear T. To the Editor: Mycobacterium Chimaera Spread from Heating and Cooling Units in Heart Surgery. N Engl J Med. 2017;376(6):601-602. doi:10.1056/NEJMc1614275

32

LivaNova Deutschland GmbH. URGENT FIELD SAFETY NOTICE Potential Cardiac Surgery Infection Risk Reduction Measure: Hydrogen Peroxide Concentration Monitoring.; 2018.

33

LivaNova Deutschland GmbH. URGENT FIELD SAFETY NOTICE Potential Cardiac Surgery Infection Risk Reduction Measure: Hydrogen Peroxide Concentration Monitoring. BfArM: Federal Institute for Drugs and Medical Devices. www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2018/13330-18_kundeninfo_en.pdf?__ blob=publicationFile&v=1. Published 2018.

34

LivaNova Deutschland GmbH. AVIS DE SÉCURITÉ URGENT Mesure visant à la réduction des risques potentiels d’infection lors d’une chirurgie cardiaque: Surveillancede la concentration de peroxyde d’hydrogène. ANSM: Agence nationale de sécurité du médicament et des produits de santé. https://www.ansm.sante.fr/S-informer/Informations-de-securite-Autres-mesures-de-securite/Generateur-thermique-de-CEC-Generateur-thermique-3T-Heater-Cooler-System-1T-Livanova-SASInformation-de-securite. Published 2018.

35

The CDP of MDAC. FDA Executive Summary: Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) during Cardiothoracic Surgery. (/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvi%0AsoryCommittee/ CirculatorySystemDevicesPanel/UCM505732.pdf).

36

FDA Safety Communication. Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication. http://wayback.archiveit. org/7993/20170722215713/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm. Published 2015.

37

Perkins KM, Lawsin A, Hasan NA, Al. E. Notes from the Field: Mycobacterium Chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery— United States. Morb Mortal Wkly Rep US Dep Heal Hum Serv Dis Control Prev. 2016;65(40):1117-1118.

38

Ministero della Salute. OGGETTO: Indicazioni Operative Riguardanti Gli Aspetti Di Laboratorio in Merito Ai Casi Di Infezione Da Mycobacterium Chimaera in Italia e Aggiornamento Delle Informazioni Disponibili.; 2019. http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2019&codLeg=68845&parte=1&serie=null.

39

Sorin Group Deutschland GMBH. Field Safety Notice: Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices.; 2014.http://www.livanova.sorin.com/products/cardiac-surgery/perfusion/hlm/3t#product_download_area.

40

Sorin Group Deutschland GMBH. Field Safety Notice: Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices.; 2014.http://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2014/04000-14_kundeninfo_en.pdf?__blob=publicationFile&v=3.

41

FRANCE SG. INFORMATION IMPORTANTE Risques de Mycobactéries En Chirurgie Cardiaque Risques de Mycobactéries En Chirurgie Cardiaque Désinfection et Nettoyage Des Générateurs Thermiques Sorin Désinfection et Nettoyage Des Générateurs Thermiques Sorin. Vol 33.; 2014. https://www.ansm.sante.fr/S-informer/Informations-desecurite-Autres-mesures-de-securite/Generateurs-thermiques-CEC-SORIN-Information-de-securite.

42

SWISSMEDIC (Swiss Agency for Therapeutic Products). Announcements: Measures for improved patient safety in cardiac surgery. https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/archive/measures-for-improved-patient-safety-in-cardiac-surgery.html. Published 2014.

43

Heredia-Rodríguez M, Hernández A, Bustamante-Munguira J, et al. Evolution of the Incidence, Mortality, and Cost of Infective Endocarditis in Spain Between 1997 and 2014. J Gen Intern Med. 2018;33(10):1610-1613. doi:10.1007/s11606-018-4514-7

44

Donlan RM, Costerton JW. Biofilms: survival mechanisms of clinically relevant microorganisms. Clin Microbiol Rev. 2002;15(2):167-193.doi:10.1128/cmr.15.2.167-193.2002

45

England PH. Mycobacterium Chimaera: infections linked to heater cooler units: Guidance for healthcare professionals on infection control and clinical aspects of M. chimaera infection associated with cardiopulmonary bypass. https://www.gov.uk/government/collections/mycobacterial-infections-associated-with-heatercooler-units.

46

FDA Safety Communication. Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication. 2018https://www.fda.gov/medical-devices/safety-communications/update-availability-deepcleaning-service-certain-livanova-plc-formerly-sorin-group-deutschland-gmbh

47

HPRA (Health Products Regulatory Authority) IRELAND. HPRA Safety Notice: SN2014(34) Medical Devices: Heater Cooler Unit. Priority 2 - Warning.; 2014.doi:10.1111/j.1365-2044.1996.tb07839.x

48

LivaNova Deutschland GmbH. FIELD SAFETY NOTICE UPDATE: Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices.; 2016. https://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2017/January/HSA 6004101-299-17-01_25 FSN_Redacted.pdf.

49

FDA Safety Communication. UPDATE: Mycobacterium Chimaera Infections Associated with LivaNova PLC (Formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System: FDA Safety Communication.; 2016. http://wayback.archive-it.org/7993/20171115052210/https://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/ucm520191.htm.

50

LivaNova Deutschland GmbH. FIELD SAFETY NOTICE - UPDATE Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices. BfArM: Federal Institute for Drugs and Medical Devices. http://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2016/10412-16_kundeninfo_en.pdf?__blob=publicationFile&v=1. Published 2016.

51

ANSM: Agence nationale de securite du medicament et des produits de sante. Information Importante – Risques de Mycobactérie Nettoyage Des Générateurs Thermiques Sorin.; 2016. https://www.ansm.sante.fr/S-informer/Informations-de-securite-Autres-mesures-de-securite/Generateurs-thermiques-CEC-SORIN-Information-desecurite.

52

Maquet Cardiopulmonary GmbH. Urgent Field Safety Notice. Revised Disinfection Procedure for Heater-Cooler Unit HCU 40.; 2016.

53

Maquet Cardiopulmonary GmbH. Urgent Field Safety Notice (FSN). Revised disinfection procedure for Heater-Cooler Unit HCU 40. BfArM: Federal Institute for Drugs and Medical Devices. http://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2016/10716-16_kundeninfo_en.pdf?__blob=publicationFile&v=2. Published 2016.

54

Engelman R, Baker RA, Likosky DS, et al. The Society of Thoracic Surgeons, The Society of Cardiovascular Anesthesiologists, and The American Society of ExtraCorporeal Technology_ Clinical Practice Guidelines for Cardiopulmonary Bypass—Temperature Management During Cardiopulmonary Bypass. J Cardiothorac Vasc Anesth. 2015;29(4):1104-1113. doi:10.1053/j.jvca.2015.07.011

55

European Centre for Disease Prevention and Control. RAPID RISK ASSESSMENT: European Centre for Disease Prevention and Control. Invasive Cardiovascular Infection by Mycobacterium Chimaera Associated with 3T Heater -Cooler System Used during Open-Heart Surgery – 18 November 2016.; 2016. https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/RRA-mycobacterium-chimaera-November-2016.pdf.

56

LivaNova Deutschland GmbH. Heater-Cooler System 3T: Operating Instructions.; 2017. doi:Version 10/2017 - CP_IFU_16-XX-XX_USA_018

57

Maquet Cardiopulmonary GmbH. Maquet HEATERCOOLER UNIT HCU 40: INSTRUCTIONS FOR USE. GERMANY; 2016.

58

Romano-bertrand S, Evrevin M, Dupont C, Frapier J, Sinquet J. Persistent contamination of heater - cooler units for extracorporeal circulation cured by chlorhexidine e alcohol in water tanks. J Hosp Infect. 2018;99(3):290-294. doi:10.1016/j.jhin.2018.01.005

59

Colangelo N, Giambuzzi I, Moro M, et al. Mycobacterium Chimaera in heater – cooler units : new technical approach for treatment, cleaning and disinfection protocol. Perfusion. 2018:1-5. doi:10.1177/0267659118814691

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