FDA Safety Alert: Non-tuberculous Mycobacterium Infections and Heater-Cooler Devices

CDC has identified a need for increased vigilance for Non-tuberculous Mycobacterium (NTM) infections by health departments, healthcare facilities, and individual healthcare providers. FDA recently issued a Safety Communication on Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices that addresses issues regarding the proper use and maintenance of these devices. CDC, in coordination with the FDA and local and state health departments, is investigating heater-cooler units associated with NTM infections and/or found to be contaminated with NTM.

Recommendations for health departments include the following:

  • Local and state health departments should communicate with healthcare facilities that perform cardiac surgical procedures, or facilities that may provide care to patients who have undergone such procedures, to ensure that the devices have been assessed, their maintenance reviewed and any potentially contaminated devices are removed from service. Clinical staff should be alerted to maintain increased awareness in identifying NTM infections potentially associated with surgery that uses heater-cooler devices.
  • Health departments should track reports from healthcare facilities regarding potential infections associated with heater-cooler units, encourage facilities to report these events to FDA, and be prepared to assist healthcare facilities with further investigation as needed. CDC is available to health departments for further consultation.

For more information, view CDC’s guidance and FDA’s safety communication.

About Alyson Jordan

Alyson Jordan serves as a Communications Specialist at NACCHO. Her work includes promoting local health departments' best practices in infectious disease and preparedness through NACCHO's communications channels, storytelling, and outreach to various audiences.

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