Heater cooler units used during open chest surgery have been linked to serious post-surgical infections.
FDA's Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices
Heater-cooler devices are used during cardiothoracic surgeries, as well as other medical and surgical procedures to warm or cool a patient to optimize medical care and improve patient outcomes. Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.
More bad news for patients who have undergone heart surgery in the past five years. A new study suggests about one-third of heater-cooler units used in cardiac procedures remain contaminated with a slow-growing, potentially fatal bacteria.
Heart failure is the leading cause of death in the US. On average, someone has a heart attack every 43 seconds. Heart health is critical to life, and heart-bypass surgery can be a lifesaver to those with heart disease. In recent years, however, researchers have discovered that the equipment used during surgery can spread dangerous bacteria.
(CNN)Patients who have undergone open heart surgeries since 2012 may be at risk of a life-threatening infection linked to a medical device used during their operations, health officials warned Thursday.
Patients who have had valve implants or prosthetic product implants are at higher risk of infection with a bacterial species of nontuberculous mycobacterium (NTM), according to the Centers for Disease Control and Prevention. Based on the number of surgeries conducted over the past four years, an estimated 600,000 patients are at risk for a potential infection.
Recent articles have described patients with infections due to a form of nontuberculous mycobacteria, Mycobacterium chimaera, that developed after cardiac surgery. Infections have been publicly reported in five countries, and it has been noted that these infections developed after the Stöckert 3T heating and cooling unit manufactured by Sorin Group Deutschland (now LivaNova) had been used to regulate the body temperature of patients during coronary-artery bypass grafting. Infections are presumed to be acquired through airborne transmission of aerosolized bacteria from water tanks.