Open-Heart Surgery Patients at Risk Due to Contaminated Devices

This past week, the Centers for Disease Control and Prevention (CDC) has issued a warning to healthcare practitioners and patients alike about contaminated Stökert 3T heater-cooler devices produced by LiveNova PLC. It is believed that these devices, commonly used for patients undergoing open-heart surgery, had been contaminated at the time of production, therefore, many patients have been put at increased risk of developing serious, even life-threatening infections.

In their Morbidity and Mortality Weekly Report, the CDC provided the public with additional information on the contaminated devices and how the contamination had been discovered. In a collaborative effort with National Jewish Health, the CDC collected isolates from hospitals located in both Pennsylvania and Iowa, states that had reported infections. The samples came from 11 patients as well as 5 Stökert 3T heater-cooler devices. Closer analysis of the samples found Mycobacterium chimaera within the heater-cooler devices, which is believed to be the cause of the reported infections.

According to a recent press release, common symptoms that patients may present with include night sweats, exhaustion, achy muscles, and fever. However, a big problem with infections caused by Mycobacterium chimaera is that symptoms could take a long time to make themselves known; this means that months or even years can go by without patients receiving appropriate diagnosis.

The aforementioned heater-cooler devices are used in 250,000 of the open-heart surgeries conducted in the United States alone, according to the CDC. These heater-cooler devices are used to regulate the temperature of patients during the surgery through the heating or cooling of water that is used in external heat exchangers or blankets.

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.” Patients who received prosthetic or valve implants are believed to be at an increased risk for infection.

In a Health Alert Network Advisory, the CDC provides healthcare facilities, healthcare practitioners, and patients with additional information regarding the heater-cooler devices and who is at increased risk of acquiring infection.

Michael Bell, MD, deputy director of CDC’s Division of Healthcare Quality Promotion said, “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 they’re maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them.”

The US Food and Drug Administration will continue to assist the CDC in efforts to reduce the risk of infection caused by these heater-cooler devices. They warn that any patients who have undergone open-heart surgery and are experiencing the symptoms described should contact their healthcare providers immediately.