The CDC issued a warning Thursday that one type of heater-cooler device — used in about 60 percent of bypass procedures in the U.S. each year — could be spreading a serious bacterial infection and urged hospitals to take immediate action.
Here are nine things to know about the devices, the infections and CDC's suggested action plan.
1. In 2015, news broke of open-heart surgery patients in the U.S. and Switzerland coming down with nontuberculous mycobacterium, or NTM, infections. Investigations linked the infections to heater-cooler devices used during the surgeries, and thousands of patients were notified of infection risk. In response to the infections, the CDC and the Food and Drug Administration issued separate guidance on the heater-cooler machines in 2015.
2. After an investigation, the CDC said Thursday the infections are linked to a specific brand of heater-coolers — the Stöckert 3T heater-cooler devices, made by LivaNova (formerly Sorin Group Deutschland).
3. Officials believe the devices were contaminated with Mycobacterium chimaera, a species of NTM bacteria, during manufacturing, since the bacteria were found at the manufacturing site in Germany.
4. Mycobacterium chimaera are often found in soil and water, and when in the environment, rarely make people ill. However, when contracted during an open-heart procedure, the bacteria can cause difficult-to-diagnose infections, as they are slow growing. The infections can be life-threatening.
5. It is believed the bacteria are aerosolized from the device, which then can result in a serious infection.
6. Stöckert 3T heater-cooler devices are used in roughly 60 percent of open-heart bypass procedures in the U.S., according to the CDC. Since more than 250,000 heart bypass procedures use heater-coolers annually in the U.S., hundreds of thousands of patients could be at risk of an NTM infection from the Stöckert 3T heater-coolers. The CDC estimates the risk of a patient getting an infection is between 1 in 100 and 1 in 1,000.
7. Michael Bell, MD, director of the CDC's Division of Healthcare Quality Promotion, urged hospitals to take action based on this news. "Hospitals should check to see which type of heater-coolers are in use, ensure that they're maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them," he said.
8. The FDA issued a safety communication this week on the devices, recommending hospitals "strictly adhere" to manufacturer instructions, establish regular cleaning for the devices and direct the heater-cooler's vent away from the patient "to mitigate the risk of aerosolizing heater-cooler tank water into the sterile field and exposing the patient." Read the full safety communication here.
9. The CDC also issued a Health Advisory on its Health Alert Network regarding the devices. According to that alert, hospitals should tell patients who are experiencing NTM infection symptoms to seek medical care and put a plan in place to communicate risks to potentially exposed patients. To see the CDC's full list of recommendations, click here.