The U.S. Food and Drug Administration (FDA) updated its Safety Communication notice from June 1, 2016, regarding the use of Stockert 3T Heater-Cooler System by LivaNova PLC to reflect increased concerns regarding the potential for infection from these machines. While the original notice warned of the connection between device use and exposure to infection, further investigation has proved the link to be stronger than originally thought in devices manufactured before September 2014, meaning many more patients may be at risk. The updated notice contains additional information about Mycobacterium chimera infections associated with the use of the heater-cooler system and includes new recommendations on ways to stop the infection from spreading.

Following the updated Safety Communication, the FDA hosted a conference call with health care providers to discuss infection risk and to review issued recommendations. Featuring experts from both the FDA and the Centers for Disease Control and Prevention (CDC), the call reiterated recommendations to reduce the spread of infection, including cleaning and disinfecting, and urged providers to evaluate their individual infection control procedures. Some facilities are experimenting with device modification to reduce the risk of contamination, but the FDA is currently unable to endorse any of these methods and encourages routine monitoring rather than mass testing due to technical challenges and potential false negatives.  Facilities should form their own analysis and carefully weigh the benefits and risks when determining to use the device in scheduled procedures and make the patient aware of possible exposure.

View the updated alert here.

Keywords: Device Approval, Mycobacterium, Safety, United States Food and Drug Administration

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