Hospitals throughout Tennessee have sent letters to patients who underwent open-heart surgery between January 2012 and November 2016, warning them that they may be at risk of a fatal infection caused by a potentially contaminated machine.
The Centers for Disease Control and Prevention (CDC) released a report on October 13 of last year alerting patients and hospitals about the potential risk of infection after learning that some LivaNova PLC, previously called Sorin Group Deutschland GmbH, Stöckert 3T heater-cooler devices, which are used in approximately 60 percent of open-heart surgeries in the United States, may have become contaminated during the manufacturing process.
These devices were previously linked to Nontuberculosis Mycobacterium (NTM) infections in Pennsylvania and Iowa. One patient in Tennessee has already been diagnosed with this infection, but officials expect more to come. Dr. Pam Talley, who works with the Tennessee Department of Health commented to News 2 that:
“We’re always concerned about infections, particularly those that are transferred in a health care setting. Being aware of the risk factors is the most important, critical piece so that we can prevent ongoing infections in the future.”
Officials believe that between 0.1 percent and 1 percent of patients whose open-heart surgery was performed at a hospital that uses these devices will contract NTM. This infection is incredibly difficult to diagnose and to treat, and is fatal if left untreated. Symptoms include:
- Unexplained fever
- Fatigue
- Weight loss
- Muscle aches
- Night sweats
The CDC also reported that patients who had prosthetic products or valves implanted during their surgeries have a greater risk of suffering from an infection. In order to diagnose this infection, doctors need to perform a specific blood test.
“That’s why the letter is so important,” continued Dr. Talley. “If the clinicians aren’t thinking about it and if the hospital isn’t thinking about it, the appropriate blood test won’t be done.”