The Centers for Disease Control and Prevention (CDC) has warned healthcare providers and patients about the potential risk of infection from certain heating cooling 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 with the rare bacteria Mycobacterium chimaera during manufacturing which could put patients at risk for life-threatening infections. CDC also recommends that hospitals should advise potentially exposed patients to seek medical care if they are experiencing symptoms such as night sweats, muscle aches, unexplained weight loss, fatigue, or unexplained fever. In addition, hospitals that use or have used this device are strongly encouraged to make and execute a plan to communicate with potentially exposed patients and to increase awareness among healthcare providers.
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.
CDC released a Health Alert Network advisory to help hospitals and healthcare providers identify and inform patients who might have been put at risk. Health care providers should also submit reports of infection transmission associated with heater-cooler devices or reports describing difficulty following the manufacturers’ instructions for use to the agency via the FDA’s Medical Device Reporting (MDR) process.
- CDC Website: Contaminated Heater-Cooler Devices
- CDC. Press Release. Contaminated Devices Putting Open-Heart Surgery Patients at Risk, 10-13-16
- CDC Health Advisory: CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery 10-13-16
- FDA Website: Heater-Cooler Devices
- FDA Information for Healthcare Providers
- FDA: Heater-Cooler Devices: Reporting Problems to the FDA
- FDA Safety Alert. UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System. 10-13-16