CDC Alert on Contaminated Heater-Cooler Devices

Alert: CDC issued a Health Alert Notice to patients and hospitals regarding the risk of NTM infections from Stöckert heater-cooler devices used during open-heart surgery. Patients who have had open-heart surgery and are having symptoms should seek medical care. While risk of infection is low, it is important to consult with your doctor.

Contaminated Devices Putting Open-Heart Surgery Patients at Risk

CDC encourages hospitals to take action, advises patients to seek care if ill

The Centers for Disease Control and Prevention (CDC) is warning healthcare providers and patients about the potential risk of infection from certain devices used during open heart (open-chest) surgery.

Patients who have had open heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever. This advice follows new information indicating that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, used during many of these surgeries, might have been contaminated during manufacturing which could put patients at risk for life-threatening infections.

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 these life-saving surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure. Approximately 60 percent of heart bypass procedures performed in the U.S. utilize the devices that have been associated with these infections. 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. While these infections can be severe, and some patients in this investigation have died, it is unclear whether the infection was a direct cause of death. Available information suggests that patients who had valves or prosthetic products implanted are at higher risk of these infections.

For more information, visit the CDC website page on this topic.

Posted 10/17/2016

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