There is the potential for organisms (including NTM) to grow in the water tanks of any heater-cooler device. Contaminated water from the 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 October 15, 2015, the FDA issued Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices - Safety Communication to help reduce the risk of infection to patients. 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 these devices.
- Strictly adhere to the cleaning and disinfection instructions provided in the manufacturer's 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 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 water that has been passed through a filter of less than or equal to 0.22 microns. Deionized water and sterile water created through reverse osmosis are not recommended because they may promote corrosion of the metal components of the system.
- Always direct and/or channel the heater-cooler'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 bacterial growth and patient infection.
- Be aware that not following the heater cooler manufacturer's cleaning instructions (frequency of cleaning and disinfection, strength of disinfectants used, etc.) 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.
- Immediately remove from service heater-cooler devices that show discoloration or cloudiness in the fluid lines/circuits. This may indicate bacterial growth. 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.
- Health care facilities should follow their internal procedures for notifying and evaluating patients if they suspect infection associated with heater-cooler devices.
- Review the communications from the Centers for Disease Control and Prevention:
- Heater-Cooler Unit Webinar. August 29, 2016
- Interim Guide for the Identification of Possible Cases of Nontuberculous Mycobacterium Infections Associated with Exposure to Heater-Cooler Units. May 13, 2016
- Non-tuberculous Mycobacterium (NTM) Infections and Heater Cooler Devices Interim Practical Guidance: Updated October 27, 2015
Recommendations Specific to the Use of the of 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 heater-cooler devices and steps health care providers and health facilities can take to mitigate risks to patients.
FDA Communication on Heater-Cooler Devices
For a complete listing of actions the FDA has taken on this issue, see FDA's Ongoing Evaluation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices.
From the Centers for Disease Control and Prevention (CDC)
- Healthcare-associated Infections: Contaminated Heater Cooler Devices
- Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery - United States October 14, 2016
- Heater-Cooler Unit Webinar. August 29, 2016
- Interim Guide for the Identification of Possible Cases of Nontuberculous Mycobacterium Infections Associated with Exposure to Heater-Cooler Units May 13, 2016
- Non-tuberculous Mycobacterium (NTM) Infections and Heater-Cooler Devices. Safety Alert. October 27, 2015