Heater-Cooler Devices - Risk of Nontuberculous Mycobacteria Infections — recall 55663

Reported risk: Health Canada is aware of international reports of nontuberculous mycobacteria (NTM) infections that have been confirmed to be associated with the heater-cooler devices used in cardiothoracic surgery. Footnote 1 Recently, Health Canada has received Canadian reports of possible NTM infections in patients with a history of cardiothoracic surgery involving the use of heater-cooler devices. The root causes for these cases are under investigation. All heater-cooler devices licensed in Canada are currently under investigation. Heater-cooler devices are non-sterile devices used in the operating room to control the patient's blood temperature during cardiothoracic surgeries, as well as other medical and surgical procedures when heating and cooling of blood is desired. Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. The water circuits are physically separated and not intended to come in contact with the patient's blood circuits. However, recent studies have suggested that there is a potential for bacteria contaminated water contained in the device to be transferred via aerosolization into the operating room environment and ultimately into the patient during open-chest heart surgery. The reported cases were infections with Mycobacterium chimaera , a slow growing NTM that is a member of the Mycobacterium avium complex, which is widespread in nature and can be found in soil and water, including drinking water sources. This type of mycobacterium was isolated from heater-cooler devices used in some hospitals and in the manufacturing process. Footnote 2 In rare cases, these nontuberculous mycobacteria may cause serious and potentially life-threatening infections in patients. Although the potential risk of NTM infections exists with all heater-cooler devices, the vast majority of reported cases were associated with the Stockert Heater Cooler System 3T manufactured by LivaNova/Sorin. Following the report of these cases, some manufacturers have taken actions in Canada to reduce the risk of patient infection. Footnote 3 Footnote 4 Footnote 5 Footnote 6 Health Canada is monitoring this issue and currently working with the manufacturers of heater-cooler devices to investigate the issue and determine additional measures to further mitigate the risk of infection.