Update: On June 14, 2022, this web page was updated to provide new information about ongoing efforts of the FDA and industry to bring to market innovative devices that can help mitigate Nontuberculous mycobacteria (NTM) infections in patients, which includes the clearance of a system that utilizes a glycol-based heat transfer fluid (HTF) instead of water.
Please see more information in the Advancing Device Design section on this page.
Heater-cooler devices are 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 include tanks that provide temperature-controlled fluid (usally water) to external heat exchangers or warming/cooling blankets through closed circuits.
Although the fluid in the circuits does not come into direct contact with the patient, there is the potential for contaminated fluid to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device's exhaust vent, or other unsealed openings, into the environment and to the patient.
On this page:
- The FDA’s Analyses of Water-Based Heater-Cooler Devices and Nontuberculous Mycobacteria (NTM) Infections
- Potential Root Causes of Contamination
- Testing Status for Cleaning and Disinfection Validation and Aerosolization
- Advancing Device Design (added 6/14/2022)
- Related FDA Communications
- Reporting Problems to the FDA
The FDA’s Analyses of Water-Based Heater-Cooler Devices and Nontuberculous Mycobacteria (NTM) Infections
Through the FDA's analysis of adverse event reports, medical literature, and information from national and international public health agencies, the FDA is aware that the use of water-based 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 in some patients.
The FDA is collaborating with professional societies, public health partners, heater-cooler manufacturers, and experts to evaluate additional strategies to mitigate infections associated with heater-cooler devices. This includes working with:
- Health care facilities and professional medical societies to understand their experiences using water-based heater-cooler units and to become more informed about challenges in diverse hospital environments, as well as their capabilities for implementing potential risk mitigation measures.
- Infectious disease specialists, health care providers, members of academia, aerosolization science and public health experts to better understand the causes and risk factors for transmission of microbial agents associated with water-based heater-cooler devices and to develop strategies to minimize patient exposure.
- The Centers for Disease Control and Prevention and state public health departments to evaluate documented events of heater-cooler contamination and subsequent patient infection.
- International public heath regulatory agencies to increase awareness of infections associated with water-based heater-cooler units and to discuss activities to reduce the risks of infection.
The FDA's current analysis has identified potential root causes of contamination from water-based heater-cooler devices, which include:
- NTM bacteria transmitted through the air (aerosolization):
There is the potential for NTM bacteria to grow in a water tank in the heater-cooler units. Although the water in the heater-cooler unit does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or disperse the NTM through the device's vent(s) or other small openings between the inside and outside of the water tanks into the operating room environment and the patient's open surgical cavity. Water agitation (bubbling) inside the water tanks via pumps, mixing components, return circuit water, etc., may increase the potential for aerosolization of NTM bacteria.
For example, mycobacteria are found in much higher concentrations in water droplets emitted into the air from air bubbles rising and bursting in the tank, as compared to the concentration of mycobacteria found in the water in the tank. The water tanks are not airtight, so these aerosolized NTM in the water droplets can escape from the inside of the heater-cooler unit possibly facilitated by the unit's fans and out the vent(s) and into the surgical suite. In addition, these water droplets containing NTM bacteria may remain suspended in the air, which may increase the chances of entering the patient's open surgical cavity or contaminating a sterile implant such as a heart valve.
- Laminar flow disruption:
Laminar air flow is an engineering control, which in this case, describes the operating room environment that is intended to add a level of protection by reducing airborne contaminants during surgery. One study, utilizing a single water-based heater-cooler unit, suggests that the device's exhaust fan, depending on the distance and direction of the exhaust, may disrupt the protective nature of the laminar air flow above the patient. The authors of this study hypothesized NTM that is airborne may then be carried into the surgical field.
- Water-Based Heater-cooler design:
The designs of most heater-cooler devices are similar since they contain between one and three large tanks filled with water that are either heated or cooled for delivery to heat exchanger(s) or blankets. While the heater-cooler device is running, the water in these tanks is agitated during normal circulation through the circuits.
Some heater-cooler devices contain air filters and water filters; others do not. Water filters (0.22 micron) should be able to remove most NTM from tap water that is used in filling/refilling, topping off, rinsing, making ice and cleaning the heater cooler units. However, the air filters located on some units are not sufficient enough to capture NTM bacteria. An air filter that has the capability of capturing NTM bacteria may alter device safety or performance and would therefore need to be evaluated by the manufacturer as a possible mitigation technique before implementation.
Fans are found on most units and are usually used to cool the unit or aid in the cooling efficiency of a compressor. These fans may facilitate the movement of aerosolized NTM from the inside of the unit into the operating room, and possibly into the sterile surgical field.
In 2015, the FDA issued a final guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Appendix E of the guidance was updated on June 9, 2017 to include water-based heater-cooler devices. The guidance document reflects the scientific advances in knowledge and technology involved in reprocessing reusable medical devices and the FDA’s current thinking on submissions associated with reprocessed medical devices.
Because water-based heater-cooler devices pose a risk of microbial transmission and patient infection through aerosolization if not adequately cleaned and disinfected, the guidance notes 510(k) submissions for these devices should include data to validate cleaning and disinfection instructions. Due to the knowledge gained since the FDA started its evaluation, the FDA is requesting methods to reduce aerosolization when applicable.
- Data to validate cleaning and disinfection instructions includes protocols and test reports demonstrating the procedures reliably and consistently achieve the specified endpoints and the instructions can be followed as intended.
- Data to reduce aerosolization includes protocols and test reports measuring the extent of aerosolization and demonstrating methods to reduce aerosolization (if occurring) are successful.
In the United States, there are currently three companies manufacturing and distributing water-based heater-cooler devices. The table below lists the manufacturers, device models, and the status of the cleaning and disinfection validation and aerosolization testing. The FDA continues to work with heater-cooler manufacturers to ensure they provide testing results, and the FDA will update the table to notify the public when test results are complete and adequate.
Table: Testing status for cleaning and disinfection validation and aerosolization with water-based heater-cooler systems for use in operating rooms by manufacturer and model
|Manufacturer||Model||Cleaning and Disinfection Validation||Aerosolization Testing|
|LivaNova||Heater-Cooler System 3T||Adequate||Adequate|
|CardioQuip||Modular Cooler- Heater 1000(i)||Pending||Pending|
|Modular Cooler-Heater 1000(m)||Pending||Pending|
|Gentherm Medical LLC||Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE||Pending||Pending|
Adequate: The FDA completed its review of the manufacturer-provided data, determined that the data achieves acceptable cleaning and disinfection, or either no aerosolization or a reduction in aerosolization was demonstrated.
Pending: The FDA is working with the manufacturer to ensure that the protocol for testing is adequate and reviewing test reports.
Based on the agency's many years of experience reviewing reprocessed devices and research conducted by the agency and others, the FDA has identified designs that foster innovation in next-generation reusable medical devices. These design features facilitate cleaning and disinfection and reduce the likelihood of contamination and aerosolization.
In May 2022, the FDA cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow Heat Exchangers. Instead of using water, the Quantum Heater-Cooler device regulates the temperature of a glycol-based heat transfer fluid (HTF), which then enters the compatible PureFlow heat exchangers to ultimately regulate the temperature of a patient’s circulating blood. The Quantum Heater-Cooler's HTF demonstrated it mitigates the risk of contamination of the device by suppressing the growth of nontuberculous mycobacteria and other bacteria.
The FDA continues to engage with manufacturers, health care facilities, and public health experts in evaluating new design features for heater-cooler devices.
|2/11/2022||FDA Warning Letter to CardioQuip, LLC||For its Modular Cooler-Heater Model MCH-1000 device (“MCH-1000 Device”) after inspections conducted at facilities in College Station, Texas revealed violations to the Quality Systems Regulation.|
|10/13/2021||UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices - Letter to Health Care Providers||To provide updated information to help mitigate potential infection risks when using heater-cooler devices by CardioQuip or Gentherm Medical LLC, and to amplify recall notices to discontinue use of heater-cooler devices by Maquet and Terumo|
|9/30/2020||Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device – Letter to Health Care Providers||To provide new information about Mycobacterium abscessus infections associated with the use of the CardioQuip Modular Cooler-Heater Device in patients who have undergone cardiothoracic surgeries and to remind users of recommendations to minimize patient exposure with any heater-cooler device.|
|2/25/2020||UPDATE: Reduce the Risk of Cardiac Surgery Infection While Using the LivaNova Heater-Cooler System 3T: FDA Safety Communication||To provide updated information to mitigate potential cardiac surgery infection risks associated with the LivaNova Heater-Cooler System 3T.|
|10/19/2018||Updated Information to Reduce Potential Cardiac Surgery Infection Risks Associated with the LivaNova 3T Heater-Cooler Systems: FDA Safety Communication||To provide updated information to mitigate potential cardiac surgery infection risks associated with the LivaNovaHeater-Cooler System 3T.|
|6/12/2018||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||To amplify LivaNova's Medical Correction issued on April 20, 2018.|
|11/1/2016||FDA Stakeholder call with health care providers and staff of health care facilities and health departments||To discuss the Agency's investigation of the LivaNova Stӧckert 3T Heater-Cooler System and to review the recommendations to help prevent the spread of infection related to the use of these devices.|
|10/13/2016||CDC: Morbidity and Mortality Weekly Report (MMWR)||Notes from the Field "Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United States". This report was written by CDC and FDA staff.|
|10/13/2016||UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System: FDA Safety Communication||Update to the June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the LivaNova PLC (formerly Sorin Group Deutschland GmBH) Stӧckert 3T Heater-Cooler System (3T) in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations to help prevent the spread of infection related to the use of these devices.|
|6/2/2016 & 6/3/2016||FDA Meeting: Circulatory System Devices Panel||Received expert clinical opinion and recommendations for patient notification and patient follow-up procedures. Recommendations for sampling and monitoring of the 3T and other heater-cooler devices were also discussed and included regular visual monitoring of contamination within the water circuit, replacement of accessories (e.g. tubing) on a regular basis and testing for water quality to assure adequate disinfection procedures are being performed.|
|6/1/2016||Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stӧckert 3T Heater-Cooler System: FDA Safety Communication||To provide new information and recommendations about Mycobacterium chimaera infections associated with the use of the Stӧckert 3T Heater-Cooler System in patients who have undergone cardiothoracic surgeries.|
|5/16/2016||Non-Tuberculous Mycobacterium (NTM) Infections Associated with Heater Cooler Devices (HCD): FDA Webinar||State, local, tribal and territorial regulatory and public health partners discussed Nontuberculous Mycobacterium (NTM) infections associated with heater-cooler devices and to review recommendations to minimize patient exposures to infections.|
|12/29/2015||FDA Warning Letter to LivaNova (formerly Sorin Group S.p.A.)||For its Heater-Cooler 3T thermal regulator device after inspections conducted at facilities in Munchen, Germany and Arvada, Colorado revealed violations to the Quality Systems Regulation. Since the LivaNova 3T heater-cooler device model is manufactured in Germany, it is under restricted import until the violations are corrected.|
|10/15/2015||Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication||To provide recommendations to minimize patient exposure.|
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.
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 communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.