At the Society of Thoracic Surgeons 53rd Annual Meeting, cardiothoracic surgeons and experts in perfusion and infectious diseases presented "Heater-Cooler-Inducted Infections: Practices, Protocols and Mitigation Strategies," which contained the most up-to-date information available.
Heater-cooler devices are used during some heart surgeries, and a specific brand of such devices — Stöckert 3T heater-cooler devices — have been implicated by the CDC in causing nontuberculous mycobacterium infections in patients. The Food and Drug Administration and the CDC have released guidance for what healthcare organizations should do if they used that brand of device.
Here are seven things to know about what new information related to these infections was given at the STS 53rd Annual Meeting.
1. The experts said infections are linked to heater-coolers from five different manufacturers, not just one, but 89 percent of the infections are linked to one manufacturer.
2. The Medical Device Report database collects reports from manufacturers, importers and user facilities as well as from physicians and patients. The database currently has 339 reports of NTM infections related to heater-coolers that happened between January 2010 and August 2016.
3. NTM infections have a latency period of up to 72 months, and symptoms tend to start about 17 months from surgery, according to Neil Fishman, MD, an infectious disease expert with the University of Pennsylvania Perelman School of Medicine in Philadelphia.
4. The risk of infection increases with length of exposure to the bacteria, which is aerosolized from the devices.
5. Overall mortality from NTM infections is greater than 50 percent, according to Dr. Fishman. Treatment isn't yet standardized, with some clinicians treating for nine months, while some extend it to a year or 18 months.
6. Kenneth G. Shann, director of perfusion services at Boston-based Massachusetts General Hospital, suggested using a checklist when cleaning heater-cooler devices, documenting the cleanings and recording serial numbers of heater-cooler devices used during procedures.
7. "This is a device problem, not a surgical problem," Dr. Fishman emphasized.