Abstract 18830: Transmission of Serious Disseminated Nontuberculous Mycobacterium (NTM) Infections to Patients During Cardiothoracic Surgery: Epidemiology and Potential Remedies
Introduction: Heater-cooler devices (HCDs) used in cardiac procedures provide temperature-controlled water to heat exchangers used in an extracorporeal circuit. The FDA has received reports of atypical infections in patients exposed to contaminated HCDs and genomic testing has identified nontuberculous mycobacteria (NTM) as the primary organism; contaminated water within the HCD is the implicated source.
Hypothesis: We assessed the hypothesis that specific HCD design features contribute to the proliferation and airborne dispersion of NTM from the device.
Methods: Between Jan 2010 and Feb 2016 the FDA Medical Device Report (MDR) database was queried for reports of patient infections and/or device contamination associated with HCDs. Subsequently, the FDA convened a Circulatory System Devices Panel in June/2016 to seek recommendations from physicians, experts in the areas of microbiology/aerosolization science and manufacturers on understanding and mitigating this concern.
Results: A total of 180 MDRs were identified which involved reports of HCD related infections in at least 66 patients (Fig 1A); of these, 14 were associated with patient death. NTM was isolated in all reported deaths. Latency from exposure to NTM to diagnosis was up to 60 months. The FDA Advisory Panel concluded that specific device design characteristics may contribute to the transmission of NTM from HCD and included: tank/circuit materials that hinder regular cleaning that favors biofilm formation (Fig 1B); device components (pumps, fans) that may enhance aerosolization; and HCD exhaust design which may encourage transmission of aerosolized NTM into the sterile field and override operating room laminar flow designs.
Conclusions: NTM infections associated with HCDs appear to have a long latency period and are frequently lethal. Cardiology/cardiothoracic surgery awareness is critical to implementing short and long term solutions to this emerging public health concern.
Author Disclosures: K.B. Allen: None. D. Yuh: None. S.B. Schwartz: None. R. Lange: None. R.A. Hopkins: None. K. Bauer: None. J. Marders: None. J.D. Donayre: None. N. Milligan: None. C. Wentz: None.
- © 2016 by American Heart Association, Inc.