Cincinnati Sub-Zero

FDA Guidance on NTM Infection and Heater-Cooler Devices

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Slide One: FDA Guidance on NTM Infection and Heater-Cooler Devices

Welcome to this training module hosted by CSZ, a Gentherm Company. Because healthcare professionals count on you, you can count on CSZ to provide you training, products and support for all of your patient temperature management needs.

In this training, we will share FDA Guidance on NTM Infection and Heater-Cooler devices. Be sure to take our quiz at the end to receive a certificate of completion from CSZ Medical, A Gentherm Company.

Slide Two: Key Learning Objectives

In today’s training module, we will cover three key learning objectives:

  1. We will introduce NTM, what it is, how it affects patients and how to identify it
  2. We will provide an overview of current guidelines from the FDA, CDC and Joint Commission
  3. Lastly, we will discuss the effects of these guidelines on hospital operations and what you need to know

So let’s begin.

Slide Three: What is NTM?

We will start by asking the question. What is NTM?

NTM is Nontuberculous mycobacteria. We are surrounded by it daily. It can be found in the ground soil and in water. In low exposure, NTM is safe. In higher exposure to immune-compromised individuals NTM can cause patient infections.

Slide Four: How is NTM acquired?

Patients most at risk to acquire an NTM infection are those that have had open cavity surgeries. NTM is transferred via aerosolized droplets from contaminated heater-cooler reservoirs. If contaminated droplets adhere to surgical implants within the patient, over time, the bacteria may spread to surrounding tissue causing potential NTM infection.

Slide Five: How Does Aerosolization Occur?

How does ‘aerosolization’ occur?

Aerosolization is the occurrence of small liquid droplets suspended in an airstream. NTM aerosolization occurs when air bubbles are created in the water reservoir of an heater-cooler device by the stirring action resulting from the unit's internal pumping of water through the system. These air bubbles then emerge into the unit's casing, carrying with them NTM organisms that may exist in a biofilm in the unit's reservoir. The organisms become airborne and are then blown out of the unit into the OR through the vents by the unit's cooling fan.

Slide Six: Recognizing and Avoiding NTM Contamination In Patients

NTM is difficult to identify in patients. The symptoms appear similar to a common cold. There are five basic symptoms; cough, night sweats, fever, weight loss, and fatigue. As you can see, NTM is similar to many other infections and the symptoms may not occur until many months or years after surgery.

Testing for NTM in a patient consists of 3 means:

  1. Acknowledgement of the common patient symptoms previously presented
  2. Radiographic-2 distinct patterns:
    • Bronchiectasis and nodular lesions in the middle lobe
    • Fibrocavitary lesions that mostly involve the upper lobes
  3. Set of 3 respiratory specimens, preferably from bronchoalveolar lavage (BAL) fluid culture.

Slide Seven: Recognizing and Avoiding NTM Contamination In the Device

To significantly reduce the risk of NTM infection overall, proper maintenance, cleaning and even design of heater-cooler devices are required.

Additionally, it is important to always use sterile or distilled water in your heater-cooler device. Do not use regular tap water which could contain NTM bacteria.

To identify NTM in your device, use a swab and send it to a lab for testing.

In addition, be sure to follow recommended guidance from the FDA, CDC and Joint Commission on NTM infection prevention.

Slide Eight: Joint Commission, FDA and CDC Guidelines for the Cleaning and Decontamination of Heater-Cooler Devices

Recommended guidance for healthcare facilities and staff have been provided by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and the Joint Commission. The key recommendations provided by all three agencies are as follows:

  • First, ensure that you are following the manufacturer’s most up-to-date instructions for cleaning and disinfecting your heater-cooler devices.
  • Be sure that your facility keeps a maintenance log for each device. The log should indicate who performed the cleaning and when it took place.
  • The Joint Commission requirement is that the maintenance and cleaning needs to be done at the time and frequency stated in the hospitals protocols,100% of the time.
  • If NTM is found within any of your heater-cooler devices it should be reported to the FDA via MedWatch.

On our podcast subscription page, you can access direct links to the FDA, CDC and Joint Commission websites where the full recommendation can be found.

Slide Nine: How Does This Affect Hospital Daily Operations?

Performing preventative maintenance on your heater-cooler devices regularly may directly impact your daily hospital operations. CSZ encourages hospitals to consider 3 areas that may be impacted; Scheduling, Manpower and Auditing requirements.

Scheduling: Cleaning heater-cooler devices takes a significant amount of time, routine maintenance of this device must be planned for; therefore, surgery schedules must be planned for accordingly.

Manpower: Cleaning of heater-cooler devices must be completed according to the manufacturer's recommendation, ensure your facility is properly trained and staffed for these requirements.

Auditing: Due to NTM risk, documentation requirements may have changed for your device, be sure your staff has the most recent manufacturer’s instructions, are properly trained and that proper documentation is maintained.

Slide Ten: Joint Commission or FDA Surveyor Audit Documentation Requirements

Documentation requirements may vary, however, key points to remember are:

  • That you must document your cleaning and disinfection process
  • You must provide assurance that the process complies with the manufacturer’s requirements
  • You must keep a maintenance log record of when the cleaning and decontamination process was performed
  • You must have 100% performance compliance

Ensuring that your team performs the requirements above will ensure a smooth audit from regulatory agencies.

Slide Eleven: Key Takeaways

In summary, NTM is a mycobacterial infection that may be caused by the aerosolization of contaminated heater-cooler reservoirs. Proper cleaning and disinfecting of these devices is required by your facility. Guidance from regulatory bodies requires 100% compliance with your facilities stated procedure, which must align with the manufacturer’s cleaning instructions. Proper maintenance has been mandated by the FDA and requires vigilance from your staff.

NTM infections can happen in any hospital. Being educated, vigilant in cleaning and detailed in documentation will set you, your staff and your patients up for safe and effective use of heater-cooler devices.

Slide Twelve: About CSZ, A Gentherm Company

CSZ, a Gentherm Company, partners with OR teams to provide a wide range of patient temperature management products, including the Hemotherm CE heater-cooler device.

At Cincinnati Sub-Zero, we put the needs of people first. You’ll notice the difference in every aspect of our work, from our quality control production procedures straight through to the variety of products and services that we offer. You’ll be at an advantage when you work with CSZ.

If you would like to learn more about heater-cooler devices or NTM guidance, you can contact us on our website or by using the telephone number on your screen.

Because they count on you, you can count on CSZ, a Gentherm Company.