FDA Issues Warning on Heater-Cooler Use During Surgery

Hello. I'm Dr Suzanne Schwartz, associate director for science and strategic partnerships at the Food and Drug Administration (FDA) Center for Devices and Radiological Health.

Recently, the FDA warned that heater-cooler devices commonly used during open-heart surgery to warm or cool a patient may transmit bacteria and cause infections, resulting in severe injury or even death. As a surgeon, I understand the need for increased awareness within the medical community on the facts surrounding heater-cooler infections and how to minimize patient risk.

What is the concern with heater-cooler devices? In particular, we are investigating the potential for nontuberculous mycobacteria (NTM) organisms to grow in the water tanks of heater-cooler devices. The investigation is broadly focused across all heater-cooler devices and not focused solely on a single product or manufacturer.

As you know, the water in these heater-cooler tanks does not come into direct contact with the patient, but these devices are not airtight or water sealed, so bacteria can transmit through the air via the exhaust vent. When the device is used during cardiopulmonary bypass procedures, there is a potential for contaminated water to become aerosolized into the operating room and enter the sterile patient environment.

Let's briefly review NTM, which are common organisms found in water and soil and are not usually harmful. However, NTM may cause infections in certain patients, such as those with compromised immune systems, who may acquire pulmonary infections through inhalation.

More recently, a different mode of NTM transmission has been identified. NTM have been transmitted via direct exposure through an open chest cavity during cardiothoracic procedures that used heater-cooler devices. These NTM infections are more invasive and occur in nonimmunocompromised patients. Because these bacteria grow slowly, it can take several months to several years for an NTM infection to develop in a patient and for symptoms to appear. These invasive infections can be life-threatening.

If you are a healthcare provider who uses any heater-cooler device, here are the FDA's three recommendations to help mitigate risk for an NTM infection.

First, adhere to the cleaning and disinfection instructions in the device labeling, and establish a regular cleaning, disinfection, and maintenance schedule for these devices.
Second, do not use tap water to rinse, fill, refill, or top off water tanks, because tap water may be contaminated with NTM. Only use sterile water or water that has been passed through a filter of ≤ 0.22 microns.
And third, because NTM can be aerosolized by a device's exhaust vent, you should always direct the heater-cooler's exhaust vent away from the surgical field to reduce potential patient exposure.

The FDA has published safety communications and other valuable resources for healthcare providers on NTM infections associated with heater-cooler devices, which can be found on our heater-cooler Web page. Please take some time to visit this page and share this information with your colleagues, including your hospital's risk manager.

The FDA continues to investigate this issue and will update the public as new information becomes available. If you suspect that your patient may have contracted an NTM infection through the use of a heater-cooler device, we encourage you to report the adverse event both to the heater-cooler manufacturer and to MedWatch, the FDA's online adverse event reporting program.

Thank you for taking the time to watch this video. I hope I've raised your awareness on this important public health issue.