Open Heart Surgery – Contaminated Heater Cooler Investigation

Oct 20, 2016 | Uncategorized

Since 2012, more than half a million open-heart surgery patients in the U.S. could be at risk for the deadly bacterial infection nontuberculous mycobacterium (NTM), due to an essential part of a machine used in life-saving surgeries: the heater-cooler unit.

The heater-cooler unit keeps a patient’s organs and circulates blood at a specific temperature during an operation and is used in about 250,000 heart by-pass procedures just in the United States every year.  

But, over the past year, the Centers for Disease Control and Prevention and the Food and Drug Administration, notified doctors and hospitals about the possible link between the machines and a NTM infection in patients.  The contaminated heater-cooler units were manufactured at a single German producer, but that means a lot more contaminated machines have yet to be identified. And even more patients have yet to be notified of a potential NTM infection.

Symptoms of a NTM infection are night sweats, weight loss, fatigue, unexplained fever or muscle aches.  The generalized symptoms result in missed or delayed diagnosis, which makes the NTM infection much harder to treat.  Patients require a specific antibiotic combination to overcome a NTM infection, often because routine antibiotics are not effective against the slow-growing NTM infection.

The Washington Post reports, in just this past year, 28 cases of NTM infections have been identified in Iowa, Michigan and Pennsylvania hospitals.  Patients in Europe have also reported infections and some infections were not diagnosed until nearly four years after surgery.

So far six hospitals across Pennsylvania, Iowa and Michigan have reported cases of NMT infections.

Hospital Name Number of Patients Notified Number of NTM Infections Surgery Dates
Wellspan York Hospital 1,300 12 10/1/11 to 7/24/15
Penn State Hershey Hospital 2,300 4 10/1/13 to 12/17/15
Penn Presbyterian Medical Center 1,100 4 1/1/12 to 1/22/16
University of Iowa 1,500 2 7/1/12 to 7/1/16
Mercy Medical Center in Iowa 2,600 2 7/1/12 to 7/1/16
Spectrum Health Medical Center in MI 4,500 2 1/1/12 to 11/10/15

The most concerning aspect for patients of recent open-heart surgery, is the possibility of NTM infection diagnosis years after surgery, as evidence by European patient reports.

The CDC wants to make the public aware of the symptoms and for those who recently had an open-heart surgery, to visit their doctor right away if you experience any symptoms of a NTM infection.

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