The following information was developed by the Society for Healthcare Epidemiology of America (SHEA) to raise awareness among healthcare providers of the possible association between Mycobacterium chimaera infections and use of heater-cooler devices.
In October 2015, the Centers for Disease Control and Prevention (CDC) released a guidance
identifying the need for increased vigilance for Non-tuberculous Mycobacterium (NTM) infections. That same month, the Food and Drug Administration (FDA) released a similar Safety Communication on Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices
to address issues regarding the proper use and maintenance of these devices. The FDA communication stated that between January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. Twenty-five of these MDRs were reported to the FDA in 2015. Additionally, several hospitals within the SHEA membership are starting to report patients with past cardiothoracic surgery developing an infection due to Mycobacterium chimaera, an infection not typically found in humans.
A research study "Prolonged Outbreak of Mycobacterium chimaera Infection After Open-Chest Heart Surgery
" published in March 2015 in Clinical Infectious Diseases on an outbreak in Switzerland determined that the water used in the heater-coolers became contaminated by M. chimaera based on how the fan on the heater-cooler unit aerosolized the organism into the air. While the water never came in contact with the patient, the aerosol spread by the fan directly contaminated the surgical wound. The study also found that when the heater-cooler devices were in the operating room but not turned on during the surgery, the organism was not aerosolized. Of the reported cases in this study, most have manifested as prosthetic valve endocarditis or vascular graft infections. Study authors pointed out the possibility that there may be involvement of the bone marrow causing cytopenias as well as splenomegaly. The patients in the study – who were not immunocompromised – presented with nonlocalizing symptoms, such as fever, myalgias, arthralgias, fatigue and weight loss. The mortality rate was approximately 50%.
Additionally, SHEA has noted that on Dec. 29, 2015, the Food and Drug Administration (FDA) issued a warning letter
to Sorin Group Deutschland GmbH specifically, in which the agency notified the firm of its intent to refuse importation of its Heater Cooler 3T device following inspections of manufacturing facilities. These violations reference undocumented and unapproved design changes made to the Heater Cooler 3T device, and complaints of patient deaths due to infection from non-tuberculosis mycobacteria (NTM), specifically Mycobacteria chimaera, dating back to January 2014. A recently filed lawsuit
is tied to this device, but is still waiting arbitration.
Testing for Mycobacterium chimaera is not standard protocol and due to the long incubation period can often present itself a significant time (i.e., years) after the surgery occurs. CDC and FDA alerts both suggest looking back 4 years for infections in patients who underwent open chest heart surgery. SHEA is working with CDC and FDA to see if updated guidance is needed and the role SHEA experts can serve. FDA is evaluating information about documented and potential infections from multiple sources, including published studies, medical device reports
submitted to the FDA, and updates from public health agencies in the U.S. and abroad. The FDA encourages health care facilities to submit reports of heater-cooler device contamination or potential infection transmission associated with heater-cooler devices as the FDA continues its investigation. SHEA is in active communication with both organizations.
The recommendation at this time is to ensure all heater-cooler devices are disinfected according to manufacturers' guidelines. SHEA volunteers and staff will continue to examine this issue.
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