October 14, 2016
Dear Hospital CEO/CMO:
On October 13, 2016, the Centers for Disease Control and Prevention (CDC) issued a Health Advisory regarding infections related to contaminated heater-cooler devices used during cardiac surgery. The use of Stӧckert 3T heater-coolers has been associated with Mycobacterium chimaera infections in patients who had open-heart surgery. Genetic testing of the organism has indicated that the devices were contaminated at the time of manufacturing.
More detail is available in the Health Advisory and at the CDC website on heater-cooler units. CDC advises hospitals performing open-chest cardiac surgery to take the following actions:
- Assess their use of heater-cooler devices and determine if they are using, or have used, the 3T devices and ensure they are following current FDA recommendations to minimize risk.
- Notify physicians who evaluate patients who have these surgeries about the risk of infection.
- Review microbiology laboratory data for positive cultures for non-tuberculous Mycobacterium from an invasive specimen and cross-check with medical and surgical records to determine if the positive result is in a surgery patient.
- Alert all potentially exposed patients about the risk of infection, and institute informed consent to educate patients about the risk of infections. The CDC website on heater-cooler units contains a toolkit with sample letters for informing physicians and notifying patients and for patients to take to their physicians.
The CDC website also includes additional resources for hospitals, including an Interim Guide for the Identification of Possible Cases of Nontuberculous Mycobacterium Infections Associated with Exposure to Heater-Cooler Units.
These infections can occur months or even years after surgery and can present in a variety of ways. Please assist us in assuring that clinicians consider the diagnosis of a mycobacterial infection in a patient with signs of infection and a history of open-chest cardiac surgery. Delayed diagnosis may increase the difficulty of treating these infections.
If your surveillance leads to the identification of a possible mycobacterial infection in a patient who has undergone one of these procedures, please report the case to the Virginia Department of Health’s Healthcare-Associated Infections Team at (804) 864-8141 and to the FDA’s MedWatch Program (http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm). Thank you for your attention to this important matter. If you have any questions, please feel free to contact your local health department.
Sincerely,
Marissa J. Levine, MD, MPH, FAAFP
State Health Commissioner