Medical Devices

Heater-Cooler Devices: Information for Health Care Providers and Staff at Health Care Facilities

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.

Recommendations for the Use of Any Heater Cooler Device

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.
  • Direct and/or channel the heater-cooler’s exhaust vent(s) away from the surgical field and toward an operating room exhaust vent 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.
    • 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:

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

On October 13, 2016, the FDA issued UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System: FDA Safety Communication to provide updated recommendations specific to the use of the Stӧckert 3T Heater-Cooler System. The recommendations include:

If your facility uses 3T devices regardless of the date of manufacture, 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 manufacturer’s or new 3T 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 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 uses 3T devices manufactured prior to September 2014, you should also:

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

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.
 

Page Last Updated: 03/28/2017
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