September 30, 2020
The U.S. Food and Drug Administration (FDA) continues to monitor the risk of Nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices, and to collaborate with stakeholders including public health partners, manufacturers, and experts to evaluate additional strategies to reduce the risk of infection from using these devices during cardiac surgery.
Today, the FDA is providing new information from our ongoing evaluation. We have recently become aware of three U.S. patients from one facility who were infected with Mycobacterium abscessus (a type of NTM) after undergoing cardiothoracic surgery involving the use of a CardioQuip Modular Cooler-Heater (MCH). Previously, the FDA had not received reports of NTM patient infection or NTM device contamination with use of the CardioQuip MCH device. At this time, the root cause of NTM patient infection and device contamination with use of this device is not known. NTM patient infections, NTM device contamination, and in some cases both issues, have now been reported for all manufacturers of heater-cooler devices in the United States.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. While we continue to evaluate this new information about the CardioQuip MCH, the FDA is reminding health care providers and staff of actions to take to reduce the risk of infection during cardiac surgery when using any heater-cooler device.
Recommendations for Health Care Providers
Health care providers and staff should review the current recommendations from the FDA for the use of any heater-cooler device to help reduce the risk of NTM infections in patients when using these devices during cardiothoracic surgeries:
- 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 heater-cooler 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 sterile water or 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 sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. Deionized water and reverse osmosis-treated water are not recommended because they may promote corrosion of the metal components of the system.
- Always direct and/or channel the heater-cooler device'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 device contamination and patient infection.
- Be aware that not following the heater-cooler manufacturer's cleaning instructions (frequency of cleaning and disinfection, strength of disinfectants used, and so forth) 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.
- Use new accessories, tubing, and connectors to prevent possible recontamination when using a different heater-cooler device.
- Be aware that device contamination may also occur from other sources such as environmental contamination or device contact with contaminated accessories.
- Clean, disinfect, and exchange heater-cooler and accessory tubing following manufacturer instructions.
- Follow manufacturer instructions for storage of heater-cooler devices and accessories when not in use, which may include removing all water from the device and tubing.
- Immediately remove from service heater-cooler devices that show discoloration or cloudiness in the fluid lines/circuits. This may indicate contamination. 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.
- Patients suspected of an infection associated with heater-cooler devices or exposed to a contaminated heater-cooler device should be notified and evaluated. Health care facilities should follow their internal procedures for notifying and evaluating patients.
- Report any issues with heater-cooler devices to the FDA, including if you suspect heater-cooler devices have led to patient infections or any type of contamination of a heater-cooler device. See Reporting Problems to the FDA below.
Heater-cooler devices are commonly used during surgeries 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.
The FDA is aware that the use of heater-cooler devices has been associated with Nontuberculous mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures. NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections or death in very ill patients and in individuals with compromised immune systems.
Since 2010, the FDA has received reports of patient infections and device contamination related to heater-cooler devices, of which there are five manufacturers in the United States. Previously, the FDA was aware of NTM patient infections and device contaminations related to four of the five manufacturers’ heater-cooler devices. Recently, the FDA received a report of three patients from one U.S. facility who developed sternal surgical site infections with Mycobacterium abscessus (a type of NTM) after undergoing cardiothoracic surgery that involved the use of a CardioQuip MCH. With this report, we are now aware of NTM patient infections, NTM device contamination, or both issues, for all the manufacturers of heater-cooler devices in the United States. Therefore, the FDA wants health care providers and users to be aware of and remain vigilant for the potential risk of NTM infections in patients who have undergone cardiothoracic surgeries using any heater-cooler device.
While the FDA believes that NTM infections in patients who have undergone cardiothoracic surgery with use of a heater-cooler device are rare, health care providers and users should be aware that these NTM infections can and do occur. Because patients infected with NTM may not develop symptoms and signs of infection for months to years after initial exposure, it is possible that some cases have not been reported to the FDA. The FDA is actively seeking prompt reporting of adverse events or suspected adverse events from users of heater-cooler devices in order to continue our evaluation of this issue.
The FDA continues to evaluate information about the risk of NTM patient infection with use of the CardioQuip MCH through follow-up with the health care facility and the manufacturer to determine factors which may have contributed to the reported events of patient infection as well as strategies to minimize patient exposure. As new and important information becomes available, the FDA will provide updates as appropriate.
For a complete listing of actions the FDA has taken on heater-cooler devices, see FDA's Ongoing Evaluation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices, including the February 2020 update on the LivaNova Heater-Cooler System 3T’s recent clearance for validated cleaning and disinfection instructions and the 3T Aerosol Collection Set. The FDA continues to engage with manufacturers, health care facilities, and the Centers for Disease Control and Prevention (CDC) in evaluating risk and mitigation measures, such as possible design changes and revised cleaning and disinfection instructions, for all heater-cooler devices.
Reporting Problems to the FDA
The FDA encourages health care providers and users to report any adverse events or suspected adverse events experienced with any heater-cooler devices, including patient infection, device contamination, or difficulty following manufacturer instructions for use.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- 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.
- User facilities participating in the FDA's Medical Product Safety Network (MedSun) should report device related adverse events through the MedSun reporting site, not through MedWatch.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).