Device used in open heart surgery could cause infections

Anyone who has recently undergone open heart surgery and developed symptoms of an infection should contact their doctor as soon as possible, the Centers for Disease Control and Prevention said Thursday. The agency is warning health care providers and patients that a device commonly used during the operation could be contaminated.

In the past year or so, there have been at least 28 cases in which bacteria from a specific device used in the surgery, known as a heater-cooler, matched bacteria found in patients, according to CDC spokeswoman Melissa Brower. Cases have been reported in Pennsylvania, Iowa and Michigan, she says.

Heater-cooler devices help keep a patient's circulating blood and organs at a safe temperature during open heart surgery, according to the CDC. The agency estimates the specific device, which is manufactured by LivaNova PLC, is used in approximately 60 percent of heart bypass procedures in the U.S.

Possible infection symptoms include fatigue, fever, muscle or joint pain, night sweats, weight loss, abdominal pain, nausea and vomiting. Because the symptoms could be the result of a variety of ailments, the infections can be difficult to detect, says Brower. Complicating detection further, it can take months or in some cases years for symptoms to appear, she says.

For those reasons, the CDC expects to learn of more infections in the future.

Loma Linda University Medical Center uses the LivaNova heater-cooler in cardiovascular surgeries, and no infections have been linked to use of the device at the hospital, according to spokeswoman Briana Pastorino.

The device is also used at Ronald Reagan UCLA Medical Center, says spokesman Phil Hampton, who adds that the hospital has found "no evidence" of the infection highlighted by the CDC. The facility has updated its cleaning regimens per FDA standards, and is closely monitoring patients who have undergone procedures that utilized the heater-cooler, he says.

Other Southern California hospitals did not respond to requests for information in time for KPCC's deadline. 

The CDC suspects the devices were contaminated during the manufacturing process in Germany. It estimates that in hospitals where at least one infection has been identified, the risk of a patient getting infected from the device during surgery is between about 1 in 100 and 1 in 1,000.

The U.S. Food and Drug Administration first raised concerns about the device in Oct. 2015, when it alerted health care providers that the device had been associated with infections. In June of this year, the FDA issued another report describing a study that found a direct link between the infection that European patients acquired during open heart surgery and the specific heater-cooler device.

Today's guidance, from the FDA and CDC, contains new recommendations for preventing infections associated with the devices. They say that health care facilities should stop using any heater-cooler devices or accessories infected with the bacteria. They also stress that for some patients, the benefits of using the device during open heart surgery generally outweigh the risk of infection.