Stӧckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication - Reports of Mycobacterium Chimaera Infections

AUDIENCE: Risk Manager, Cardiology, Surgery, Infectious Disease, Nursing

ISSUE: FDA is updating its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the Stӧckert 3T Heater-Cooler System (3T) in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations to help prevent the spread of infection related to the use of these devices. For the complete list of recommendations, see the updated FDA Safety Communication.

BACKGROUND: Heater-cooler devices are commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient in order to optimize medical care and improve patient outcomes. Heater-cooler devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device's exhaust vent into the environment and to the patient. In October 2015, the FDA issued a Safety Communication to provide recommendations to help minimize patient risk of infections associated with heater-cooler devices. Since issuing that communication, the FDA has continued to evaluate the causes and risk factors for transmission of microbial agents associated with heater-cooler devices and has collaborated with professional societies, public health partners, and experts to develop strategies to minimize patient exposure.

RECOMMENDATIONS: UPDATED recommendations for health care facilities and staff:

If your facility uses 3T devices, you should:

Immediately remove from service any heater-cooler devices, accessories, tubing, and connectors that have tested positive for M. chimaera or have been associated with known M. chimaera patient infections at your facility.
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.
Be aware that device contamination also may occur from other sources such as environmental contamination or device contact with contaminated accessories.
Review the recommendations in CDC's Health Advisory
Be aware that heater-cooler devices are important in patient care. In appropriately selected patients, the benefits of temperature control during open chest cardiothoracic procedures generally outweigh the risk of infection transmission associated with the use of these devices.

If your facility has 3T devices manufactured prior to September 2014, you should:

Strongly consider transitioning away from the use of these devices for open-chest cardiac surgery until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection. ◦Use of these devices should be limited to emergent and/or life-threatening situations if no other heater cooler devices are available.
- Follow the FDA's earlier recommendations to help mitigate the risks of patient infection.
- Be aware that testing of heater-cooler devices to identify units contaminated with M. chimaera presents technical challenges related to sample collection, the long culture time, and the high rate of false negative tests. Therefore, it is not recommended at this time.

If your facility has 3T devices manufactured after September 2014, you should:

Follow the FDA's earlier recommendations to help mitigate the risks of patient infection.
Be aware that testing of heater-cooler devices to identify units contaminated with M. chimaera presents technical challenges related to sample collection, the long culture time, and the high rate of false negative tests. Therefore, it is not recommended at this time.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the FDA Safety Communication and CDC alerts, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm525147.htm