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Safety alert: Bacterial infections associated with heater-cooler devices

Accreditation Insider, November 16, 2015

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Last month, the FDA and Centers for Disease Control and Prevention (CDC) released a safety communication concerning Nontuberculous mycobacterium (NTM) infections related to heater-cooler devices. 


Heater-cooler devices are commonly used during cardiac surgical procedures to warm and cool a patient's blood during cardiopulmonary bypass. The FDA received 25 medical device reports in 2015 about patient infections associated with heater-cooler devices. In some of these cases, patients developed infections several months to years after the surgical procedure. Typically, surgical site infections are typically observed 30-90 days after surgery.


Is the cause of these infections similar to the infectious outbreak associated with endoscopes? "No, this is a separate story," says Margaret Price, PhD, CIC, previously director, infection control and occupational health at St. Luke's Episcopal Health System in Houston. "There's never been a link with that machine before. These organisms are what we call slow-growers; many mycobacteria grow slowly, and so these patients have developed infections as long as five to 14 months after surgery."


The heater-cooler device is in the OR with the patient and has water going through it, but historically, the way the circuits are designed, there has never been contact between the patient's blood and water, Price says.


This is an excerpt from an article in the monthly training resource Briefings on Accreditation and Quality. To read more, click here to login or subscribe.



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