Federal health officials on Thursday warned hospitals and patients that heater-cooler devices used during open-heart surgery could potentially cause deadly infections. No infections tied to the machines have been reported in Washington.
Federal health officials are warning hospitals and patients that certain devices used during open-heart surgery could potentially cause deadly infections.
The Centers for Disease Control and Prevention (CDC) on Friday issued a health alert indicating that some LivaNova PLC Stockert 3T heater-cooler devices, made by the firm formerly known as the Sorin Group Deutschland GmbH, may have been contaminated during manufacturing, which could “put patients at risk for life-threatening infections.”
The heater-cooler units, which are used to regulate patient blood temperature during surgery, are the types of devices that tested positive for the bacteria that cause Legionnaires’ disease in an outbreak last month at the University of Washington Medical Center that infected five people, including two who died.
However, UW Medicine does not use the 3T brand of devices, hospital officials have said. Instead, the hospital uses heater-cooler units made by CardioQuip of Bryan, Texas, which have not been tied to infections. No cases of Legionnaires’ disease have been publicly linked to heater-cooler devices, although infection-control experts said it is possible infections could be spread that way.
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It was not immediately clear whether any hospitals in Washington state use the 3T devices.
CDC officials issued the warning after recent tests indicated that bacteria from the 3T heater-cooler devices match bacteria found in patients in several states. Infections were caused by Mycobacterium chimaera, a type of nontuberculosis mycobacterium, or NTM.
The Washington State Department of Health said Thursday that no NTM infections linked to heater-cooler units have been reported in the state.
More than 250,000 heart-bypass procedures using heater-cooler devices are performed in the U.S. every year, the CDC said. About 60 percent of those procedures are performed using the devices associated with infections. CDC officials estimated that in hospitals where an infection has been detected, the risk of a patient becoming infected was between about 1-in-100 and 1-in-1,000. Initial investigations indicate that patients who had valves or prosthetic devices implanted are at higher risk.
Officials with the CDC and the federal Food and Drug Administration issued alerts about potential infections linked to the heater-cooler units in 2015.
Patients who have had open-heart surgery should seek medical care if they show signs of infection, including night sweats, muscle aches, weight loss, fatigue or unexplained fever, CDC officials said.
The UW Medicine Legionnaires’ disease outbreak may be over, King County health officials said this week. No new cases have been reported and more than twice the typical incubation time for illness has passed, said Dr. Jeff Duchin, health officer for Public Health — Seattle & King County.