U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Cardiovascular Devices
  5. What is a Heater-Cooler Device?
  6. Recommendations for the Use of Water-Based Heater Cooler Devices
  1. What is a Heater-Cooler Device?

Recommendations for the Use of Water-Based Heater Cooler Devices

There is the potential for microorganisms (including NTM) to grow in the fluid tanks of any heater-cooler device. Contaminated water from a water-based heater-cooler device has the potential to aerosolize into the operating room during surgery. This may lead to infection, primarily in cardiovascular patients undergoing open-chest surgical procedures.

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.

On this page:

Recommendations for the Use of Water-Based Heater Cooler Devices

The FDA has the following recommendations to help reduce the risk of infection to patients when using a water-based heater-cooler device. The recommendations include:

  • 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 water-based heater cooler devices.
  • Strictly adhere to the cleaning and disinfection instructions provided in the manufacturer's heater-cooler device labeling. Ensure you have the most current version of the manufacturer's instructions for use readily available for staff who interact with these devices.
  • DO NOT use tap water to rinse, fill, refill, or top-off heater-cooler water tanks since this may introduce NTM organisms. Use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. When making ice needed for use in the heater-cooler, use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. Deionized water and reverse osmosis-treated water are not recommended because they may promote corrosion of the metal components of the system.
  • Always direct and/or channel the heater-cooler device's exhaust vent(s) away from the surgical/sterile fields and toward an operating room exhaust vent during device set-up and surgical procedures as well as after use to mitigate the risk of aerosolized heater-cooler tank water reaching the sterile field.
  • Establish regular cleaning, disinfection and maintenance schedules for heater-cooler devices according to the manufacturer's instructions to minimize the risk of device contamination and patient infection.
    • Be aware that not following the heater-cooler manufacturer's cleaning instructions (frequency of cleaning and disinfection, strength of disinfectants used, and so forth) can damage the device.
    • Follow a comprehensive quality control program for maintenance, cleaning, and disinfection of heater-cooler devices. This may include written procedures for monitoring adherence to the program and documenting set up, cleaning, and disinfection processes before and after use.
    • Use new accessories, tubing, and connectors to prevent possible recontamination when using a different heater-cooler device.
    • Be aware that device contamination may also occur from other sources such as environmental contamination or device contact with contaminated accessories.
    • Clean, disinfect and exchange heater-cooler and accessory tubing as per the manufacturer recommendations
    • Follow manufacturer instructions for storage of heater-cooler devices and accessories when not in use, which may include removing all water from the device and tubing.
  • Immediately remove from service heater-cooler devices that show discoloration or cloudiness in the fluid lines/circuits. This may indicate contamination. Consult your hospital infection control officials to perform the appropriate follow up measures and report events of device contamination to the manufacturer.
  • Consider performing environmental, air, and water sampling and monitoring if heater-cooler contamination is suspected. Environmental monitoring requires specialized expertise and equipment to collect and process samples, which may not be feasible in all facilities.
  • Patients suspected of an infection associated with heater-cooler devices or exposed to a contaminated heater-cooler device should be notified and evaluated. Health care facilities should follow their internal procedures for notifying and evaluating patients.
  • Report any issues with heater-cooler devices to the FDA, including if you suspect heater-cooler devices have led to patient infections or any type of contamination of a heater-cooler device. See Reporting Problems to the FDA.

Recommendations Specific to the Use of the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Heater-Cooler System 3T (formerly Stӧckert 3T Heater-Cooler System):

On February 25, 2020, the FDA issued a Safety Communication to remind health care providers and staff of actions to take to reduce the risk of cardiac surgery infection when using the LivaNova Heater-Cooler System 3T. In addition, the FDA cleared a new version of the Heater-Cooler System 3T with changes to help reduce the risk of patient infections including updated labeling  with validated cleaning and disinfection instructions and the 3T Aerosol Collection Set.

Recommendations for Health Care Providers and Staff

  • Strictly adhere to the updated 3T Operating Instructions (Version 21) in order to reduce the risk of infection. Be aware of LivaNova's February 25, 2020 Medical Device Correction Letter.
  • Use new accessories, tubing, and connectors to prevent contamination 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 may also occur from other sources such as environmental contamination or device contact with contaminated accessories.
  • Be sure to clean and disinfect any accessories connected to the heater cooler according to accessories' manufacturers' instructions for use.
  • Be aware that more frequent cleaning and using higher disinfection concentrations can damage the device.

If using a LivaNova Heater-Cooler System 3T that is not the new version (i.e. has a serial number starting with 16S):

  • Be aware of LivaNova's previous Urgent Medical Device Correction letters .
  • Be aware of the 3T Aerosol Collection Set.  
    • LivaNova has developed a vacuum canister and internal sealing design change called the 3T Aerosol Collection Set that is intended to further reduce, but does not eliminate, the risk of airborne transmission of non-tuberculosis mycobacterium (NTM) from the 3T device.
    • A LivaNova representative or local agent will contact customers to plan the upgrade of the affected products.
    • 3T devices that are at the deep cleaning facility will be upgraded while there.
  • Be aware of the availability of the deep cleaning service. The "deep-cleaning" service is available for all 3T devices  less than 10 years old (the expected device lifetime).
  • If your device was manufactured prior to September 2014, you should strongly consider transitioning away from the use of these devices for open-cardiac surgery unless your device has successfully been deep cleaned by LivaNova.

If your 3T device is known or suspected to be contaminated, 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.
  • Consider contacting LivaNova for additional information about the "deep-cleaning" servicing of your 3T.
  • Be aware, if your device is successfully deep cleaned, following the routine cleaning and disinfection procedures found in the most recent Instructions for Use is necessary to help reduce the risk of recontamination.
  • Review the FDA's earlier recommendations provided to help reduce the risk to patients.

Summary of Resources

Below is a summary of communications available, including those provided by other government and international public health regulatory agencies, that heighten awareness about infections associated with water-based heater-cooler devices and steps health care providers and health facilities can take to mitigate risks to patients.

For a listing of the most significant activities by the FDA on this issue, see FDA's Ongoing Evaluation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Water-Based Heater-Cooler Devices.

From the Centers for Disease Control and Prevention (CDC)

From International Public Health Agencies

Back to Top