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MUSC Health urges heart bypass patients to monitor health closely in wake of FDA findings

Staff Report | brazell@musc.edu | January 25, 2017

heart bypass
Photo by J. Ryne Danielson
A student in the College of Health Professions receives training in the simulation lab on a heart-lung device used for cardiopulmonary bypass surgery.

Providing high-quality and safe care is MUSC Health’s top priority, and leadership has been concerned with recent reports that heater-cooler equipment used in open-heart procedures was infected with potentially harmful bacteria in the manufacturing process.

To date, MUSC Health has found no evidence of any heater-cooler-related infections in affected patients. However, clinicians, staff, and leadership want to assure patients and the public that MUSC Health has followed and will continue to follow guidance from the Federal Drug Administration and the Centers for Disease Control and Prevention to minimize any risk of infection and notify affected patients of the potential risks related to these devices.

The MUSC Health team is also working to replace these devices while taking steps to mitigate potential exposure to patients. More detailed information is available from the CDC.

The FDA has been monitoring the infection risk associated with use of the Stӧckert 3T Heater-Cooler System, which controls the temperature of blood during some open-heart surgeries. Some patients across the country have contracted an infection called Mycobacterium chimaera after exposure to infected devices. MUSC Health, along with 60 percent of all the nation’s heart surgery programs, uses this equipment during surgeries such as coronary bypass and heart or lung transplantations. 

The infection is slow growing and difficult to diagnose and cannot be spread person-to- person. It is possible to develop symptoms years after surgery, so it is important for those affected to be aware of those symptoms. Patients who have undergone surgery requiring the use of heart bypass devices should discuss any symptoms they may have with their primary care provider.

Symptoms of this kind of infection may include:

  • Night sweats
  • Muscle aches
  • Unexplained weight loss
  • Fatigue
  • Unexplained fever

According to the CDC, the risk of infection is low, with a recent press release stating: "in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000." The CDC release adds that available information suggests that patients who had valves or prosthetic products implanted are at higher risk of these infections.

MUSC Health encourages concerned patients, family members or the public to reach out if there are additional questions by calling 843-792-5555. A member of the MUSC Health team will return any calls within two business days. If someone feels that a medical emergency is underway based on symptoms being experienced, MUSC Health encourages those individuals to contact their primary care provider or visit an emergency care provider immediately.