BACKGROUND: Investigators in Switzerland reported a cluster of six patients diagnosed with Mycobacterium chimaera in the spring of 2015. All six cases had open-chest surgery performed in facilities with Stӧckert 3T Heater-Cooler System manufactured by LiveNova PLC (formerly Sorin Group Deutschland GmbH). Between January 2010 and August 2015, the U.S. Food and Drug Administration (FDA) received thirty-two Medical Device Reports (MDRs) regarding infections associated with heater-cooler devices (HCD). In October 2015, FDA released the first official recommendations, regarding the use of Sorin 3T devices. In October 2016, FDA updated their recommendations and the Centers for Disease Control and Prevention (CDC) utilized the Health Alert Network advising hospitals to notify patients who were potentially exposed to this HCD. The Tennessee Department of Health (TDH) developed a RedCAP database to determine which facilities had heater-cooler devices, as well as determine compliance with FDA/CDC recommendations.
METHODS: TDH identified 47 facilities from 2014 and 2015 hospital discharge data, as well as the National Healthcare Safety Network, which performed at least one of the following procedures: abdominal aortic aneurysm repair, cardiac surgery, coronary bypass with chest incisions, and coronary bypass with chest and donor incisions, or heart transplant. Infection preventionists were targeted at each facility, but they were encouraged to consult perfusionists. Facilities were asked about the manufacturer of HCDs. If Sorin 3T devices were used at any point, they were also asked about the dates of use and implementation of manufacturer’s 2015 instructions and FDA/CDC recommendations.
RESULTS: Twenty-six facilities reported the use of any HCD and 18 (69%) used at least one Sorin 3T device. A majority of Sorin 3T users had implemented October 2015 FDA recommendations (94%) and reviewed microbiology laboratory databases for M. chimaera or M. avium complex cultures (67%). Very few facilities had implemented informed consent or prospective surveillance. Twelve facilities utilized data sources such as the Society of Thoracic Surgeons (STS) database and Hospital Discharge data to identify potentially exposed patients. Among these twelve facilities, it was estimated approximately 18,133 patients were possibly exposed to potentially contaminated HCDs.
CONCLUSIONS: TDH utilized survey information collected to raise awareness and identify gaps in implementation of current FDA/CDC recommendations. Additionally, this survey provided TDH a preliminary understanding of the number of potentially exposed patients. TDH was able to use these survey data to rapidly ascertain potential exposures in two suspect case investigations.