According to Reuters, the U.S. Centers for Disease Control and Prevention (CDC) issued a warning over the risk of serious bacterial infection to patients who have undergone open-heart surgery because of possible contamination of a device made by LivaNova Plc that is commonly used in procedures.
LivaNova Stockert 3T heater-cooler device used to keep a patient’s circulating blood and organs at a certain temperature may have been contaminated during manufacturing. This puts patients at risk for a life-threatening infection.
If a patient has had open-heart surgery, they should seek medical care if experiencing these symptoms: night sweats, muscle aches, weight loss, fatigue, or unexplained fever.
According to CDC, about 60 percent of more than 250,000 heart bypass procedures in the U.S. use LivaNova devices each year.
The Deputy Director of CDC’s Healthcare Quality Promotion division stated that hospitals need to check to see what type of heater-coolers are being used, make sure that they are maintained according to the latest manufacturer instructions, and let affected patients know along with the clinicians who care for them.
Unfortunately, some patients in this investigation have died, but it is unknown how many were infected and whether infection was the direct cause of death.
Patients exposed to the bacteria during surgery can also develop nonspecific symptoms that can take months to develop. This can cause diagnosis of the infections to be missed or delayed, which doesn’t help the problem and makes it more difficult to treat.
London-based LivaNova said that they are working with regulators to come up with a solution to address their concerns and ensure continued access to the significant device, which enables lifesaving cardiac surgery.
The evidence shows the bacteria, Mycobacterium chimaera, contaminated the devices during manufacturing in Germany. CDC reported that they will continue working with the FDA and clinical community to analyze more and reduce risk from these devices, while also increasing awareness to providers and patients.
CDC mentioned that recalling the device was not likely because of how often the devices are used. A spokeswoman from CDC also told Reuters that if you took them all out of service at one time, there wouldn’t be an option to be able to perform the critical and life-saving surgeries.