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CDC warns of infection risk from open-heart surgery devices
The CDC has issued a warning to health care providers and patients concerning the risk for infection from certain open-heart surgery devices.
In a press release, the agency stated that as a result of new information it received on the contamination of certain heater-cooler devices (Stöckert 3T, LivaNova PLC) during manufacturing, patients who had open-heart surgery and are experiencing symptoms commonly linked to infection should seek medical care.
According to the CDC, approximately 60% of heart bypass procedures performed in the U.S. use a device associated with the infections. The FDA issued a warning about the problem in June.
In a recent MMWR, the CDC published results of laboratory tests showing bacteria from the devices match those from infected patients in several states; the culprit bacteria is Mycobacterium chimaera. Patients exposed to the bacteria through open-heart surgery may take months to develop nonspecific symptoms, which can lead to a diagnosis being missed or delayed for years, according to the CDC.
The estimated risk for infection in patients treated in hospitals where an infection has already been identified is between one in 100 and one in 1,000, according to the agency.
The CDC also stated that while infections can be severe and some patients died, the direct cause of death could not be determined.
Patients with valves or other implanted prosthetic products appear to be at higher risk for infection than patients with nothing implanted.
The agency also issued a Health Alert Network advisory to assist hospitals and health care providers in identifying and providing guidance to patients who may be at risk for infection.
The CDC has previously released information and alerts concerning heater-cooler devices that might be contaminated and will continue to work with the FDA and health care providers to evaluate and reduce infection risk associated with these devices while keeping patients and providers informed, according to the release.
“It is important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly,” Michael Bell, MD, deputy director of CDC’s Division of Healthcare Quality Promotion, said in a press release. “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.”
- References:
- CDC. CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery. October 19, 2016. https://emergency.cdc.gov/han/han00397.asp. Accessed October 19, 2016.
- CDC. Non-tuberculous Mycobacterium (NTM) Infections and Heater-Cooler Devices Interim Practical Guidance: Updated October 27, 2015. http://www.cdc.gov/HAI/pdfs/outbreaks/CDC-Notice-Heater-Cooler-Units-final-clean.pdf. Accessed October 19, 2016.
- FDA. Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication. October 15, 2015. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm. Accessed October 19, 2016.
- FDA. UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T Heater-Cooler System: FDA Safety Communication. October 13, 2016. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm520191.htm. Accessed October 19, 2016.
- Perkins KM, et al. MMWR Morb Mortal Wkly Rep. 2016;doi:10.15585/mmwr.mm6540a6.
Disclosure: Bell reports no relevant financial disclosures.