The Centers for Disease Control has acknowledged that contaminated heater-cooler devices used for open chest surgeries threaten heart surgery patients. The CDC is warning healthcare providers and patients about the potential risk of infection from devices used for open heart surgery. The agency recommends hospitals take action, and it advises patients who suspect infection to seek care.
Infection Symptoms: Sweats, Aches, Weight Loss, Fatigue, Fever
CDC announced on Oct. 13, 2016 that people who had open heart surgery should see a doctor if they experience infection symptoms such as night sweats, muscle aches, weight loss, fatigue, fever.
Stöckert 3T heater-cooler devices
The CDC advice follows reports that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, which are used during open heart surgeries, might have been contaminated during their manufacture. That contamination could put patients at risk for life-threatening infections.
250,000 Heart Bypasses Yearly
More than 250,000 heart bypass procedures using heater-cooler devices are performed in the U.S. yearly, some 60 percent of total bypasses in the country. Heater-cooler units are used during surgery to help keep a patient’s circulating blood and organs at a specific temperature. CDC estimates that in affected hospitals, the risk of a patient getting an infection from the bacteria was between 1/100 and 1/1,000. CDC admits these infections can be severe and that some patients have died, but says it is unclear whether the infection caused death.
Valve and Prosthetics Patients at Higher Risk
The CDC has also cautioned that patients with implanted valves or prosthetics are at higher risk of these potentially deadly infections.
October 2016 CDC Health Alert Network Advisory
“It’s important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly,” said Michael Bell, M.D., deputy director of CDC’s Division of Healthcare Quality Promotion. “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.”
CDC and the FDA initially published information and alerts about Stockert 3T heater-cooler device problems in 2015. Then in October 2016, CDC’s Morbidity and Mortality Weekly Report covered recent laboratory tests by CDC and National Jewish Health which show bacteria from 3T heater-cooler devices match bacteria found in patients in several states.
German Manufacturing Problems Revealed
Results of the latest tests add to previous evidence from Europe that suggests bacteria which contaminated these devices came from the device’s manufacturing process in Germany.
Mycobacterium chimaera Bacteria
The bacteria, Mycobacterium chimaera, is a species of nontuberculous mycobacterium (NTM) often found in soil and water. M. chimaera rarely makes healthy people sick in normal circumstances, but patients who have been exposed to it through open-heart surgery can develop general and nonspecific symptoms which can often take months to manifest. Diagnosis of these infections can consequently be missed or delayed for months or years, which adds to treatment difficulties. No test yet exists to determine whether a person has been exposed to the bacteria. Laboratory culture is needed to diagnose infections. The slow growth of the bacteria means it can take months for infection to be ruled out.
Contaminated Devices threaten Heart Surgery Patients
CDC says it will continue to work with the FDA and the clinical community to further evaluate and reduce the risk associated with these devices. The agency recommends that open-heart surgery survivors concerned with any symptoms contact their healthcare providers.
- Stockert 3T Heater-Cooler Lawsuit
- Contaminated Devices put Open-Heart Surgery Patients at Risk
- Contaminated Devices threaten Heart Surgery Patients