Medical 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.
    • 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:

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

On October 19, 2018, the FDA issued a Safety Communication to ensure customers were aware of LivaNova's Medical Device Correction about hydrogen peroxide concentration decrease and the availability of the vacuum overflow and internal sealing.

The FDA continues to recommend health care providers follow the recommendations provided in the June 12, 2018, Safety Communication to help prevent the spread of infection related to the use of LivaNova's 3T heater-cooler devices. In this Safety Communication, the FDA is also amplifying LivaNova’s Medical Device Correction issued on April 20, 2018. In this letter, LivaNova announced the availability of a “deep-cleaning” service to clean LivaNova’s 3T heater-cooler devices that are suspected of contamination and/or contain visible biofilm. The “deep-cleaning” service will be available for all 3T devices less than 10 years old (the expected device lifetime) and LivaNova will prioritize the availability of the “deep-cleaning” service according to the following criteria:

  1. 3T heater-cooler devices known or suspected to be contaminated with nontuberculous mycobacterium, based on the facilities testing program or other information known to the facility;
  2. 3T heater-cooler devices manufactured before September 2014; then
  3. 3T heater-cooler devices manufactured after September 2014 and not known or suspected to be contaminated with nontuberculous mycobacterium.

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.

If your 3T device was manufactured prior to September 2014, you should:

  • Consider contacting LivaNova for additional information about the “deep cleaning” servicing of your 3T.
  • Strongly consider transitioning away from the use of these devices for open-chest cardiac surgery unless your device has successfully been deep cleaned by LivaNova.
  • 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.

If your 3T device was manufactured after September 2014 and not known or suspected to be contaminated with nontuberculous mycobacterium, you should:

  • 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 may also occur from other sources such as environmental contamination or device contact with contaminated accessories.
  • Ensure that you are cleaning and disinfecting 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.
  • Review the recommendations in CDC’s Health Advisory.

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 and Cooler Devices
From the Centers for Disease Control and Prevention (CDC)
From International Public Health Agencies

 

Page Last Updated: 10/19/2018
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