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Heater-Cooler Devices Linked to Heart Surgery Infections Half a Million May be at Risk

Oct 13, 2016

Heater-Cooler Devices

Livanova Heater-Cooler Devices

Contaminated heater-cooler devices manufactured by LivaNova, formerly known as Sorin Group S.p.A., have been linked to serious infections in patients undergoing open heart surgery since 2012. During surgery, heater-cooler units are used to keep a patient's blood and organs at a specific temperature. The device utilizes a water reservoir, where the bacteria can grow. The water sometimes evaporates or sprays into the operating room air, allowing contaminants into the patient's open chest cavity.

The Washington Post reports that genetic fingerprinting has linked the infections to a single source, where the machines were manufactured in Germany. Over the past year, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have been notifying hospitals and doctors of the issue but this latest piece of evidence provides the strongest association. The fact that the infections have been traced to a single source means that other machines may also be tainted, placing half a million people at risk.

WellSpan York Hospital in York, Pa. was the first to report a group of NTM infections. A hospital spokesperson said 12 patients suffered infections and six died, although it is unclear if the deaths are due to the devices because patients had other medical problems.

The Number Who Were Exposed Might Be Much Larger.

"Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger," the CDC stated.

The bacteria in question is known as nontuberculous mycobacterium (NTM), which is normally found in the environment and not typically harmful to healthy individuals. However, it can lead to life-threatening infections in patients undergoing invasive procedures or people with compromised immune systems.

This year alone, there have been 28 NTM infections linked to the heater-cooler devices, Washington Post reports. The infections were identified in Iowa, Michigan and Pennsylvania. Furthermore, infections do not appear to be isolated to the United States. A number of cases have also been reported in Europe.

NTM is a slow-growing bacteria, and the infection can be difficult to diagnose. Patients may not exhibit symptoms for months and when they do, they can easily be mistaken for another health problem. In Europe, some patients were not diagnosed for four years.

Symptoms of NTM infection include night sweats, muscle aches, weight loss, fatigue or unexplained fever. A specific combination is used to treat the infection, as routine antibiotics are ineffective.

Washington Post reports that the manufacturer failed to take into account how the device needs to be cleaned. CDC deputy director of health care quality promotion Mike Bell commented that "some smart engineer designed it because surgeons said they need to keep this cool and that warm," according to Washington Post. "But no one probably said, it needs not to have a fan because it wasn't part of the calculation. The person who wanted this machine, they weren't thinking about maintenance and repair."

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