FDA Safety Alert: Nontuberculous Mycobacteria Infections Associated With Heater-Cooler Devices

By on 6:03 AM

The U.S. Food and Drug Administration (FDA) has released a safety alert for healthcare professionals regarding reports of patient infection after use of oxygenator heat exchangers, cardioplegia heat exchangers and warming/cooling blankets. 

Nontuberculous Mycobacteria (NTM) appears to have been associated with these devices, particularly in patients undergoing cardiothoracic surgical procedures.

NTM are ubiquitous in nature, and are found mainly in water and soil. They are typically not harmful, but may cause infections in very ill patients or in individuals with compromised immune systems.

For further information regarding the FDA findings relating to these infections, as well as FDA recommendations, click here.

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years' experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.