Outbreak of bacterial infections linked to medical device

New York hospital administrators may have read the results of a study published in a peer-review medical journal that addressed the relationship of infections in patients who had cardiac surgery with a machine commonly used during the procedure. According to the study, bacterial contamination by this type of machine has been noted around the world.

The problem reportedly causing the infections is linked to a heater-cooler device used during cardiac surgeries. The device, used in connection with heart-lung machines in approximately 250,000 cardiac surgeries performed each year in the United States, works as a heat exchange. However, a bacterium called Mycobacterium chimaera that grows slowly and spreads has been linked to infections caused by contaminated HCDs. In patients who have undergone cardiac surgery, up to two months may be required to rule out an M. chimaera infection.

Investigators searching for the source of the infections examined the water circuitry of HCDs and found the bacteria present in circuits used in the machines. In addition, the bacteria was found airborne during surgeries, specifically in the HCDs manufactured by Liva Nova. A warning was issued by the Centers for Disease Control and Prevention stating that the devices may have become contaminated at some time during the process of manufacturing. According to the CDC, about 60 percent of all cardiac surgeries are performed utilizing this device, and patients undergoing cardiac valve replacements are at higher risk.

Although the continued use of this device after warnings have been issued may constitute hospital negligence, a more likely cause of action for patients who have been harmed would be a products liability lawsuit grounded on manufacturer's negligence. An attorney who has experience in this type of litigation might assist an injured patient in seeking appropriate compensation.

Source: Medscape, "CDC: Infection Risk for LivaNova Heater-Cooler Devices for Heart Surgeries," Larry Hand, Oct. 13, 2016

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