Nontuberculous mycobacteria (NTM) infections and contamination associated with heater-cooler devices, especially during cardiac surgery are a growing concern. According to the FDA’s Medical Device Review (MDR) database, US hospitals across 10 states account for 34% of infections or device contamination worldwide.

NTM is a naturally occurring group of bacteria found in soil and water, including chlorinated water. Aerosolization from heater-cooler devices has been shown to contaminate the sterile operative field resulting in patient infections.

In June 2015, LivaNova (formerly Sorin), the manufacturer of HT 3 heater-cooler devices, issued a field safety notice with disinfection protocols. Recommendations included implementing microbiological monitoring to verify effectiveness. Monthly tests include: heterotrophic plate count, coliform bacteria, Pseudomonas aeruginosa, and nontuberculous mycobacteria.

Special Pathogens Laboratory (SPL) isolated Mycobacterium chimaera from 25 of 43 heater-cooler devices. Reports found this same species at LivaNova’s production facility in Germany. Diagnosing M.chimaera infections is complicated as symptoms may not appear until one to three years after surgery. However, SPL’s early data shows a decrease in contamination after clients disinfected their devices.

For NTM testing and developing a quality monitoring plan, please contact Jack Rihs or call 412-281-5335. Learn more.

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