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More Than Half a Million Open-Heart Surgery Patients at Risk for Infection

three surgeons in scrubs around patient

According to The Washington Post, more than 500,000 Americans who received open-heart surgery since 2012 could be at risk of a bacterial infection due to the device used in their procedure.

Although Rare, Infection May Cause Death

The bacteria in question, nontuberculous mycobacterium (NTM), is not only difficult to detect but some patients won’t show symptoms of an infection for months after exposure. In some cases in European patients, diagnoses were made nearly four years after their surgery.

In addition, the symptoms of the infection are rather general, including night sweats, muscle aches, weight loss, fatigue, and fever, reports The Washington Post. Late diagnosis of the infection makes it tougher to treat and potentially more deadly.

An estimated 250,000 heart-bypass surgeries are performed in America each year, with roughly 60 percent involving the German-made device linked to the deadly bacteria. The device is a heater-cooler unit that keeps a patient’s blood circulating and organs at a specific temperature during the surgery.

According to The Washington Post, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have alerted hospitals and doctors about the potentially infected devices. The CDC says the number of patients exposed to the bacteria may actually be higher than reported.

Risk Much Lower Than Other Common Surgical Site Infections

Although the risk of infection remains low, there have already been 28 cases identified in several Midwest hospitals in the United States this year, according to The Washington Post.

The company that manufacturers the heater-cooler machines has updated hospitals on how to properly clean them and reduce the risk of bacteria growth. The Washington Post reports that the machines contain an engineering flaw that makes them hard to clean. In addition, the device has a water reservoir that can harbor bacteria growth.

LivaNova, the device’s manufacturer, says they have received complaints about patient deaths related to NTM infections and the use of their devices. At a Pennsylvania hospital, twelve patients had the infection in 2015 – six of these patients, who also had other medical conditions, died.

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