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

Website New Episode w Special Guests
  • Press Release

NACCHO’s Podcast From Washington: New Changes to the WIC...

On this week’s episode: New Changes to WIC Program and Local Health Officer...

Apr 19, 2024

NACCHO’s Podcast From Washington: New Changes to the WIC...

Picture1
  • Community Health Health & Disability

Transformative Health Data Approaches Within the...

CDC is assisting LHDs with technical assistance to improve the quality of data...

Apr 19, 2024 | Jerome Bronson

Transformative Health Data Approaches Within the...

Philly MRC web main
  • Medical Reserve Corps

Fostering Volunteer Retention and Engagement through...

See how the Philadelphia Medical Reserve Corps builds and fosters connections...

Apr 18, 2024 | Beth Hess

Fostering Volunteer Retention and Engagement through...

I Stock 498649859
  • Funding Opportunity Health Equity & Social Justice

Request for Proposals: Website Developer for Health...

NACCHO is seeking a consultant to develop a dynamic website for NACCHO’s...

Apr 17, 2024 | Andrea Grenadier

Request for Proposals: Website Developer for Health...

Screenshot 2024 04 17 083518
  • Tools & Resources

NACCHO Website Gets a Fresh Look: Explore the Latest...

Check out the recent updates to NACCHO.org and explore the revamped website.

Apr 17, 2024 | Angie McPherson

NACCHO Website Gets a Fresh Look: Explore the Latest...

NAACHO Infographic1
  • Community Health Community Resilience COVID-19 Performance Improvement

COVID Workforce Project Infographics

Check out infographics designed as part of an initiative to highlight the...

Apr 11, 2024 | Andrea Grenadier

COVID Workforce Project Infographics

NAACHO Full Page Greene jpg Page 1
  • Community Health Community Resilience COVID-19 Performance Improvement

Listening to the Community and Co-creating Solutions...

Fewer than 12k people call rural Greene County home. It may be a small...

Apr 11, 2024 | Andrea Grenadier

Listening to the Community and Co-creating Solutions...

NAACHO Full Page Lewis Page 1
  • Community Health Community Resilience COVID-19 Performance Improvement

Building on Personal Relationships to Serve the...

Lewis County, KY, stretches across nearly 500 square miles of wooded hills and...

Apr 11, 2024 | Andrea Grenadier

Building on Personal Relationships to Serve the...

NAACHO Full Page Marietta Belpre Page 1
  • Community Health Community Resilience COVID-19 Performance Improvement

Carrying Forward Lessons Learned from the COVID-19...

Marietta/Belpre Health Department serves a rural population of roughly 20k...

Apr 11, 2024 | Andrea Grenadier

Carrying Forward Lessons Learned from the COVID-19...

Back to Top