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Mycobacterium chimaera infections among cardiothoracic surgery patients associated with heater-cooler devices—Kansas and California, 2019

Published online by Cambridge University Press:  06 October 2021

Kerui Xu*
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia
Lauren E. Finn
Affiliation:
Los Angeles County Department of Public Health, Los Angeles, California
Robert L. Geist
Affiliation:
Kansas Department of Health and Environment, Topeka, Kansas
Christopher Prestel
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia
Heather Moulton-Meissner
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia
Moon Kim
Affiliation:
Los Angeles County Department of Public Health, Los Angeles, California
Bryna Stacey
Affiliation:
Kansas Department of Health and Environment, Topeka, Kansas
Gillian A. McAllister
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia
Paige Gable
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia
Talar Kamali
Affiliation:
Los Angeles County Department of Public Health, Los Angeles, California
Annabelle de St Maurice
Affiliation:
Department of Pediatrics, Division of Pediatric Infectious Diseases, University of California at Los Angeles, Los Angeles, California
Shangxin Yang
Affiliation:
Department of Pathology and Laboratory Medicine, University of California at Los Angeles, Los Angeles, CA
Kiran M. Perkins
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia
Matthew B. Crist*
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia
*
Author for correspondence: Kerui Xu, E-mail: [email protected]. Or Matthew B. Crist, E-mail: [email protected]
Author for correspondence: Kerui Xu, E-mail: [email protected]. Or Matthew B. Crist, E-mail: [email protected]

Abstract

Background:

In 2015, an international outbreak of Mycobacterium chimaera infections among patients undergoing cardiothoracic surgeries was associated with exposure to contaminated LivaNova 3T heater-cooler devices (HCDs). From June 2017 to October 2020, the Centers for Disease Control and Prevention was notified of 18 patients with M. chimaera infections who had undergone cardiothoracic surgeries at 2 hospitals in Kansas (14 patients) and California (4 patients); 17 had exposure to 3T HCDs. Whole-genome sequencing of the clinical and environmental isolates matched the global outbreak strain identified in 2015.

Methods:

Investigations were conducted at each hospital to determine the cause of ongoing infections. Investigative methods included query of microbiologic records to identify additional cases, medical chart review, observations of operating room setup, HCD use and maintenance practices, and collection of HCD and environmental samples.

Results:

Onsite observations identified deviations in the positioning and maintenance of the 3T HCDs from the US Food and Drug Administration (FDA) recommendations and the manufacturer’s updated cleaning and disinfection protocols. Additionally, most 3T HCDs had not undergone the recommended vacuum and sealing upgrades by the manufacturer to decrease the dispersal of M. chimaera–containing aerosols into the operating room, despite hospital requests to the manufacturer.

Conclusions:

These findings highlight the need for continued awareness of the risk of M. chimaera infections associated with 3T HCDs, even if the devices are newly manufactured. Hospitals should maintain vigilance in adhering to FDA recommendations and the manufacturer’s protocols and in identifying patients with potential M. chimaera infections with exposure to these devices.

Type
Original Article
Copyright
© The Author(s), 2021. Published by Cambridge University Press on behalf of The Society for Healthcare Epidemiology of America

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Footnotes

a

Authors of equal contribution.

References

Trudzinski, FC, Schlotthauer, U, Kamp, A, et al. Clinical implications of Mycobacterium chimaera detection in thermoregulatory devices used for extracorporeal membrane oxygenation (ECMO), Germany, 2015 to 2016. Euro Surveill 2016;21(46):30398.CrossRefGoogle Scholar
Perkins, KM, Lawsin, A, Hasan, NA, et al. Notes from the Field. Mycobacterium chimaera contamination of heater-cooler devices used in cardiac surgery—United States. Morb Mortal Wkly Rep 2016;65:11171118.CrossRefGoogle ScholarPubMed
Lyman, MM, Grigg, C, Kinsey, CB, et al. Invasive nontuberculous mycobacterial infections among cardiothoracic surgical patients exposed to heater-cooler devices. Emerg Infect Dis 2017;23:796805.CrossRefGoogle Scholar
Sax, H, Bloemberg, G, Hasse, B, et al. Prolonged outbreak of Mycobacterium chimaera infection after open-chest heart surgery. Clin Infect Dis 2015;61:6775.CrossRefGoogle ScholarPubMed
Jarashow, MC, Terashita, D, Balter, S, Schwartz, B. Notes from the field: Mycobacteria chimaera infections associated with heater-cooler unit use during cardiopulmonary bypass surgery—Los Angeles County, 2012–2016. Morb Mortal Wkly Rep 2019;67:14281429.CrossRefGoogle ScholarPubMed
Update: reduce the risk of cardiac surgery infection while using the LivaNova heater-cooler system 3T: FDA safety communication. US Food and Drug Administration website. https://www.fda.gov/medical-devices/safety-communications/update-reduce-risk-cardiac-surgery-infection-while-using-livanova-heater-cooler-system-3t-fda-safety. Published 2020. Accessed August 2, 2021.Google Scholar
Haller, S, Höller, C, Jacobshagen, A, et al. Contamination during production of heater-cooler units by Mycobacterium chimaera potential cause for invasive cardiovascular infections: results of an outbreak investigation in Germany. Euro Surveill 2016;21(17):pii:30215.CrossRefGoogle ScholarPubMed
Nontuberculous Mycobacterium infections associated with heater-cooler devices: FDA safety communication. US Food and Drug Administration website. https://wayback.archive-it.org/7993/20170404182156/https:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm. Published 2015. Accessed August 2, 2021.Google Scholar
LivaNova Deutschland GmbH. Mitigating potential cardiac surgery infection risks. Linova website. https://www.livanova.com/LivaNova-Public/media/Images/Hydrogen-Peroxide-Monitoring-and-Design-Upgrade-Customer-Letter-r1.pdf?ext=.pdf. Published 2018. Accessed July 30 2021.Google Scholar
Update: availability of deep-cleaning service of certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stockert 3T heater-cooler systems in the US: FDA safety communication. US Food and Drug Administration website. https://www.fda.gov/medical-devices/safety-communications/update-availability-deep-cleaning-service-certain-livanova-plc-formerly-sorin-group-deutschland-gmbh. Published 2018. Accessed August 1, 2021.Google Scholar
Heater-cooler system 3T operating instructions (version 21). LivaNova Deutschland GmbH website. https://livanovamediaprod.azureedge.net/livanova-media/livanova-public/media/resources01/cp_ifu_16-xx-xx_usa_021.pdf?ext=.pdf. Published 2020. Accessed November 16, 2020.Google Scholar
Hasan, NA, Lawsin, A, Perry, KA, et al. Complete genome sequence of Mycobacterium chimaera strain CDC2015-22-71. Genome Announc 2017;5(31):e0069317.CrossRefGoogle ScholarPubMed
Garvey, MI, Ashford, R, Bradley, CW, et al. Decontamination of heater-cooler units associated with contamination by atypical mycobacteria. J Hosp Infect 2016;93:229234.CrossRefGoogle ScholarPubMed
CDC advises hospitals to alert patients at risk from contaminated heater-cooler devices used during cardiac surgery. Centers for Disease Control and Prevention website. https://emergency.cdc.gov/han/han00397.asp. Published 2016. Accessed December 3, 2020.Google Scholar
Recommendations for the use of any heater cooler device. US Food and Drug Administration website. https://www.fda.gov/medical-devices/what-heater-cooler-device/recommendations-use-any-heater-cooler-device. Published 2020. Accessed March 21, 2021.Google Scholar
Medical device reporting (MDR): how to report medical device problems. US Food and Drug Administration website. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. Published 2020. Accessed August 1, 2021.Google Scholar