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Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication

Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication

June 12, 2018

Audiences:

  • Health care providers who use 3T Heater-Cooler System
  • Primary care providers who are responsible for the ongoing care of patients who have undergone cardiothoracic surgery
  • Patients who have undergone cardiothoracic surgery
  • 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

Medical Specialties:

Cardiothoracic Surgeons, Cardiovascular Surgeons, Orthopedic Surgeons, Neurosurgeons, General Surgeons, Anesthesiologists, Infection Control, Infectious Disease Physicians, Pediatrics, Primary Care, and Intensive Care Physicians

Product:

The Stӧckert 3T Heater-Cooler System (3T), manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), is intended to provide temperature-controlled water to 1) oxygenator heat exchangers, 2) cardioplegia (paralysis of the heart) heat exchangers, and/or 3) warming/cooling blankets to warm or cool a patient during cardiopulmonary bypass procedures lasting six hours or less.

Purpose:

The FDA is issuing this communication to provide updated recommendations to U.S. health care facilities that use the 3T to help prevent the spread of infection related to the use of these devices. This communication also amplifies LivaNova’s Medical Device Correctiondisclaimer icon issued on April 20, 2018 announcing the availability of "deep cleaning" services of certain 3Ts in the U.S. that are suspected of contamination and/or contain visible biofilm. The “deep cleaning” service is intended to help mitigate cardiac surgery Mycobacterium infection risks.

Summary of Problem and Scope:

Heater-cooler devices are commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient to optimize medical care and improve 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, transmitting bacteria through the air and through the device’s exhaust vent or other unsealed pathways (channels), 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.

On June 1, 2016, the FDA issued a Safety Communication specific to Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T. Testing conducted by the manufacturer in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility. The 3T devices manufactured at this facility were distributed worldwide. In response to the M. chimaera findings in August 2014, the manufacturer added cleaning and disinfection procedures to the production line in September 2014. Samples taken at the same manufacturing facility by the German Regulatory Authorities in July 2015 did not show M. chimaera, potentially indicating the contamination at the manufacturing facility had been resolved. Although the manufacturer of 3T devices added cleaning and disinfection procedures to the production line in September 2014, the FDA is aware of some 3T devices manufactured after September 2014 which have tested positive for M. chimaera.

On October 13, 2016, the FDA issued an updated Safety Communication to provide new information about M. chimaera infections associated with the use of the 3T devices in U.S. patients who have undergone cardiothoracic surgeries. This communication also contained updated recommendations to help prevent the spread of infection related to the use of these devices.

Since issuing the October 2016 communication, the FDA has continued to evaluate the causes and risk factors for transmission of microbial agents associated with heater-cooler devices and has collaborated with professional societies, public health partners, and experts to develop strategies to minimize patient exposure.

On April 20, 2018, LivaNova issued a Medical Device Correction letter to health care facilities for mitigating cardiac surgery Mycobacterium risks. In this letter, LivaNova announced the availability of a “deep-cleaning” service in the U.S. to clean certain 3T devices suspected of contamination and/or containing visible biofilm. FDA reviewed the validation data submitted by LivaNova and found it to be adequate. As a result, LivaNova announced the availability of a "deep-cleaning" service in the U.S. for all 3T devices less than 10 years old (the expected device lifetime). This "deep cleaning service" is expected to remove visible biofilm and reduce microbial levels to below specific limits. However, because heater-cooler devices are non-sterile, recontamination may occur. Strict adherence to the manufacturers cleaning and disinfection procedures in their most recent Instructions for Use may reduce the risk of recontamination. 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.

The FDA will continue to work with LivaNova to mitigate the concern of 3T device contamination and subsequent Mycobacterium infection risks.

Updated Recommendations for Health Care Facilities and Staff:

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 will be necessary to help reduce the risk of recontamination.
  • Review the "General Recommendations" provided below 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 will be necessary to help reduce the risk of recontamination.
  • Review the “General Recommendations” provided below to help reduce the risk to patients.

General Recommendations: 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 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.
  • 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.

Additional recommendations for the use of any heater cooler device is available on FDA’s Heater-Cooler Devices "Heater-Cooler Devices: Information for Health Care Providers and Staff at Health Care Facilities" webpage.

Recommendations for Patients:

  • Be aware that:
    • in the U.S., most cardiopulmonary bypass procedures involve the use of a heater-cooler device.
    • heater-cooler devices are important in patient care and, in appropriately selected patients, the benefits of temperature control necessary during open chest cardiothoracic procedures generally outweigh the risk of infection transmission associated with using these devices.
    • the FDA has received reports of patient infections associated with exposure to M. chimaera when contaminated 3T heater-cooler device were used during surgery.
    • M. chimaera infections are difficult to detect because infected patients may not develop symptoms or signs of infection for months to years after initial exposure.
    • there may be an increased risk of infection if you received a heart valve, graft, left ventricular assist device (LVAD), or any other prosthetic product/material or had a heart transplant.
  • If you have undergone cardiopulmonary bypass, be aware of the possible signs and symptoms of nontuberculous mycobacterium (NTM) infection. These may include:
    • fatigue
    • fever
    • pain
    • redness, heat, or pus at the surgical site
    • muscle pain
    • joint pain
    • night sweats
    • weight loss
    • abdominal pain
    • nausea
    • vomiting
  • If you have undergone a cardiopulmonary bypass procedure and are experiencing any of the signs and symptoms of NTM infection as outlined above, contact your health care provider as soon as possible.
  • If you are not currently experiencing any changes in your general health, inform your health care provider during your next wellness visit that you have undergone a cardiopulmonary bypass procedure to determine if you require further testing or monitoring for possible exposure to NTM.

Additional information for patients is available on FDA’s Heater-Cooler Devices "Information for Patients" webpage.

FDA Activities:

The FDA continues to be actively engaged with the manufacturer, health care facilities and the CDC in evaluating risk and mitigation measures and will provide updates, as appropriate, as new information becomes available.

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 via 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.

Additional Resources:

FDA Communications on Heater-Cooler Devices

From the Centers for Disease Control and Prevention (CDC)

Contact Information:

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.