The Centers for Disease Control has issued a serious health warning for those who may have undergone open heart surgery recently.
The CDC urges health care providers and patients to be wary of any bacterial infections caused by the Stockert 3T heater-cooler devices made by LiveNova corp. The devices are “possibly” contaminated, according to the center. Around 60% of the 250,000 heart bypass procedures carried out in the U.S. use this branded device.
These machines are designed to monitor and maintain a patient’s temperature during open heart surgery, and it’s believed that many were susceptible to contamination during manufacture.
Patients who have had open-heart surgery should seek medical care if they are experiencing symptoms such as night sweats, muscle aches, weight loss, fatigue or unexplained fever, CDC said. “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,” Michael Bell, deputy director of CDC’s Healthcare Quality Promotion division, said in a statement.
The CDC and the U.S. Food and Drug Administration first published information about the potentially contaminated devices in 2015. The evidence acquired so far suggests the bacteria, Mycobacterium chimaera, contaminated devices during manufacturing in Germany. “We are working with regulators to develop a solution that addresses their concerns and ensures continued clinician access to this important device, which enables lifesaving cardiac surgery,” London-based LivaNova said in a statement.
A number of individuals involved in this investigation have died following their surgery, and it’s unclear if the contaminated device is to blame. According to CDC, many of the symptoms associated with the infection take months to materialize, at which point it can be too late to treat.
LivaNova’s products remain in circulation as the CDC claims that it would be even more damaging to recall them.
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