October 19, 2018
- Health care providers who use 3T Heater-Cooler System
- Hospital staff who are responsible for operating and maintaining 3T Heater-Cooler System
- Health care facilities that perform procedures using the 3T Heater-Cooler System
Cardiothoracic Surgeons, Cardiovascular Surgeons, Orthopedic Surgeons, Neurosurgeons, General Surgeons, Anesthesiologists, Infection Control, Infectious Disease Physicians, Pediatrics, Primary Care, and Intensive Care Physicians
The Stöckert 3T Heater-Cooler System (3T), manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), is intended to provide temperature-controlled water to:
- oxygenator heat exchangers,
- cardioplegia (paralysis of the heart) heat exchangers, and
- warming/cooling blankets to warm or cool a patient during cardiopulmonary bypass procedures lasting six hours or less.
On October 18, 2018, LivaNova issued a Medical Device Correction letter to inform customers of actions to take to reduce potential cardiac surgery infection associated with the 3T Heater-Cooler Systems. The FDA is issuing this communication to help share the information provided by LivaNova.
Summary of Problem and Scope
Heater-cooler devices are commonly used to warm or cool a patient to improve medical care and 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. This could send bacteria through the air and through the device's exhaust vent or other unsealed pathways, 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 the October 2015 communication, the FDA has continued to evaluate the causes and risk factors for transmission of microbial agents associated with heater-cooler devices and has worked with professional societies, public health partners, and experts to develop strategies to minimize patient exposure.
To help reduce potential risk of infection during cardiac surgery, on October 18, 2018, LivaNova issued a Medical Device Correction letter to health care facilities to:
- Provide updated instructions to monitor the concentration of hydrogen peroxide in the water circuit to verify that sufficient concentration of hydrogen peroxide is present to limit microbial growth, and to adjust the concentration of hydrogen peroxide if it drops below 100 ppm.
- Announce the availability of a design upgrade (vacuum canister and internal sealing) that reduces the risk of potential emission of aerosols from the 3T.
Recommendations for Health Care Facilities
- Be aware of LivaNova's Urgent Medical Device Correction letter.
- Return the Customer Response Form included as an attachment with LivaNova's Urgent Medical Device Correction letter.
- Continue to follow the 3T operating instructions
- Follow the Daily Hydrogen Peroxide Monitoring Instructions.
- Users should monitor the hydrogen peroxide concentration in the water solution on a daily basis to verify that sufficient concentration of hydrogen peroxide is present in the water circuit of the device. A decrease in hydrogen peroxide over the 7-day period until the next water change is expected, however the hydrogen peroxide concentration should remain above 100 ppm.
- Be aware of the 3T Design Upgrade.
- LivaNova has developed a vacuum canister and internal sealing design change 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.
The FDA continues to be actively engaged with the manufacturer, health care facilities and the Centers for Disease Control and Prevention (CDC) in evaluating risk and mitigation measures, conducting its own scientific research and will provide updates, as appropriate, as new information becomes available.
Visit the FDA's heater-cooler information webpage for a complete listing of actions the agency has taken on this issue.
Reporting Problems to the FDA
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with the use of medical devices. Health care providers should submit voluntary reports of infection transmission associated with heater-cooler devices or reports describing difficulty following the manufacturers' instructions for use to the agency through the Medical Device Reporting (MDR) process. If a health care provider suspects bacterial contamination of the heater-cooler device following use, we encourage the health care provider to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
FDA Communications on Heater-Cooler Devices
- Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stockert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication (June 12, 2018)
- Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stöckert 3T Heater-Cooler System: FDA Safety Communication (June 1, 2016) - ARCHIVED
- Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication (October 15, 2015) - ARCHIVED
- Heater-Cooler Informational Webpage
From the Centers for Disease Control and Prevention (CDC)
- Perkins KM, Lawsin A, Hasan N, et al. Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery – United States MMWR Morb Mortal Wkly Rep 2016:1117-1118. DOI http://dx.doi.org/10.15585/mmwr.mm6540a6
- CDC Health Advisory: CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery (October 13, 2016) - ARCHIVED
- 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 (October 27, 2015)
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV. 800-638-2041 or 301-796-7100.