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

Oct 21, 2015 | Alyson Jordan

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

More posts by Alyson Jordan

Related Posts

D4 web

Day Four Highlights: 2024 Preparedness Summit

See highlights from the final day of the 2024 Preparedness Summit.

Mar 28, 2024

Day Four Highlights: 2024 Preparedness Summit

I Stock 1182682774
  • Adverse Childhood Experiences (ACEs)
  • Behavioral Health
  • Community Health
  • Injury and Violence Prevention

Seeking LHD Participants for an Intersectional Data...

With support from the Centers for Disease Control and Prevention, NACCHO is...

Mar 28, 2024 | Camille Adams

Seeking LHD Participants for an Intersectional Data...

Ps24 posters d3 web

Day Three Highlights: 2024 Preparedness Summit

See highlights from day three of the 2024 Preparedness Summit.

Mar 27, 2024

Day Three Highlights: 2024 Preparedness Summit

D2 highlights web

Day Two Highlights: 2024 Preparedness Summit

See highlights from day two of the 2024 Preparedness Summit.

Mar 26, 2024

Day Two Highlights: 2024 Preparedness Summit

PS24 1

Day One Highlights: 2024 Preparedness Summit

See highlights from day one of the 2024 Preparedness Summit.

Mar 25, 2024

Day One Highlights: 2024 Preparedness Summit

PS24 web
  • Tools & Resources
  • Training

Welcome to the 2024 Preparedness Summit!

Welcome to the 2024 Preparedness Summit.

Mar 25, 2024 | Beth Hess

Welcome to the 2024 Preparedness Summit!

Stakeholder Conference Call on the FDA Integrated Food...

You’re invited to join the call on April 2 to hear more.

Mar 25, 2024

Stakeholder Conference Call on the FDA Integrated Food...

Cover and Spine for MAPP 2 0 Handbook Copy Page 1
  • Mobilizing for Action through Planning and Partnerships (MAPP)
  • Performance Improvement
  • Workforce Development

Register to Attend a Mobilizing for Action through...

Registration is now open for NACCHO’s in-person Mobilizing for Action through...

Mar 23, 2024 | Andrea Grenadier

Register to Attend a Mobilizing for Action through...

Capitol bulding

Congress Releases Labor-HHS Bill in Final FY2024 Package

Early on March 21st, Congress released the final minibus package for Fiscal...

Mar 22, 2024 | Victoria Van de Vate

Congress Releases Labor-HHS Bill in Final FY2024 Package

Back to Top