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After further investigating Myocobacterium chimaera infections associated with the Sorin/LivaNova Stöckert 3T Heater-Cooler System used for temperature control during cardiothoracic surgery, the FDA .

Facilities should immediately stop using any 3T device or accessory that has tested positive for M. chimaera or has interacted with an infected patient, the agency recommended.

Hospitals should also "strongly consider" moving away from use of any 3T device manufactured before September 2014, when it might have been shipped from a contaminated facility, and only use them when there is no other option in emergent or life-threatening situations.

The agency didn't recommend testing each machine, old or new, for M. chimaera because of challenges such as long culture time and a high rate of false negative results.

For all 3T devices in use, the agency's directions were:

• Use new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device.
• Direct and channel the heater-cooler exhaust away from the patient, e.g., to the operating room exhaust vent.
• Follow the FDA's earlier recommendations to mitigate the risks of patient infection.

A detailed how investigators traced M. chimaera infections back to production line contamination. Notifications of potential exposure after the initial warnings in 2015 might not have gone far enough, it suggested in Morbidity and Mortality Weekly Report.

"Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger. Over 250,000 procedures using cardiopulmonary bypass are performed in the United States each year. Stöckert 3T heater-cooler devices represent approximately 60% of the U.S. market."

The CDC is working with the FDA to raise awareness of the issue.

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