Bacterial contamination has been reported in every brand of a surgical heater-cooler unit, based on Food and Drug Administration (FDA) adverse event database reports. Four of the five devices have resulted in patient infections and three have been associated with deaths. A new study has found that most of the devices associated with patient infections in the U.S. and Europe were contaminated at the LiveNova 3T device manufacturing plant, according to MedPage Today.
However, other brands of heater-cooler units show the contamination is more widely distributed and that some devices linked to a patient infection may have been contaminated locally, according to the study, which was published in the journal Lancet Infectious Diseases.
The heater-cooler units are commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient in order to optimize medical care and improve patient outcomes. The devices have water tanks that provide temperature-controlled water to external heat exchanges or warming/cooling blankets through closed circuits. Although the water in the circuits does not come in contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.
Last year, the Centers for Disease Control and Prevention (CDC) reported that some LivaNova (formerly Sorin Group Deutschland) Stöckert 3T heater-cooler devices may have been contaminated with Mycobacterium chimaera (M.chimaera), which is ubiquitous in the environment and particularly endemic to plumbing.
Surprisingly, the manufacturer of the 3T heater-cooler unit tested its devices with water at the plant and shipped them wet to customers.
In the largest genomic investigation to date on the emerging pathogen, heater-cooler units were identified as a source of Chimaera outbreaks in patients, leading Jennifer Gardy, PhD, of the British Columbia Centre for Disease Control and University of British Columbia in Vancouver, in an accompanying commentary to conclude, “Operating rooms and other hospital settings with patients at increased risk of infection should be devoid of such uncontrolled water sources. Clinicians should be aware of this disease, its origin, and its likely global occurrence.”