On October 13, 2016, the CDC issued a warning to healthcare providers and patients that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices used during many of open heart surgeries might have been contaminated during manufacturing which could put patients at risk for life-threatening infections.
The contamination involves the bacterium Mycobacterium chimaera (M. chimaera), which is often found in soil and water. In the environment, M. chimaera rarely makes healthy people sick; however, patients who have been exposed to the bacteria through open-heart surgery can develop general and nonspecific symptoms that can often take months to develop, which means that the diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat. There is no test to determine whether a person has been exposed to the bacteria but infections can be diagnosed by detecting the bacteria by laboratory culture (the slow-growing nature of the bacteria can require up to two months to rule out infection).
The CDC warns patients who have had open heart surgery that they should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever.
The CDC and FDA initially published information and alerts about these potentially contaminated heater-cooler devices in 2015. The CDC’s Morbidity and Mortality Weekly Report published on October 13, 2016 detailed recently completed laboratory tests by the CDC and National Jewish Health that show bacteria from the 3T heater-cooler devices match bacteria found in patients in several states. Previous evidence from Europe suggests the bacteria contaminated these devices during manufacturing in Germany.
More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year. Heater-cooler units are an essential part of heart bypass surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure. Approximately 60% of heart bypass procedures performed in the U.S. utilize the devices that have been associated with the infections.
The CDC estimates that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000. The infections can be severe and some patients have died, but it is unclear whether the infection was a direct cause of death. Available information suggests that patients who had heart valves or prosthetic products implanted are at higher risk of infection.
In announcing the warning, the CDC’s Deputy Director of the Division of Healthcare Quality Promotion stated, “It’s important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly. Hospitals should check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them.”
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