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FDA Safety Communication Update: Mycobacterium chimaera infections associated with 3T Heater-Cooler SystemsOct212016

Update Oct 24th: You can also read Health Canada’s recall alert on this.

The FDA has updated its 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 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.

PICNet is sharing this notification from the FDA as a follow-up to the information that we shared in January 2016. All health authorities should continue to monitor their cardiac surgery heater/cooler units to ensure that proper cleaning protocols are followed and recommendations to mitigate the risk of transmission of non-tuberculosis mycobacterium from these machines are in place.

Below are the updated Recommendations for Health Care Facilities and Staff; please also read the full article (dated Oct 13, 2016) on the FDA website.

If your facility uses 3T devices, 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.
  • Use new accessories, tubing, and connectors to prevent recontamination 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 also may occur from other sources such as environmental contamination or device contact with contaminated accessories.
  • Review the recommendations in CDC’s Health Advisory
  • 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.

If your facility has 3T devices manufactured prior to September 2014, you should:

  • Strongly consider transitioning away from the use of these devices for open-chest cardiac surgery until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection.
    • Use of these devices should be limited to emergent and/or life-threatening situations if no other heater cooler devices are available.
    • Follow the FDA’s earlier recommendations to help mitigate the risks of patient infection.
    • Be aware that testing of heater-cooler devices to identify units contaminated with M. chimaera presents technical challenges related to sample collection, the long culture time, and the high rate of false negative tests. Therefore, it is not recommended at this time.

If your facility has 3T devices manufactured after September 2014, you should:

  • Follow the FDA’s earlier recommendations to help mitigate the risks of patient infection.
  • Be aware that testing of heater-cooler devices to identify units contaminated with M. chimaera presents technical challenges related to sample collection, the long culture time, and the high rate of false negative tests. Therefore, it is not recommended at this time.

The FDA recommends facilities and staff using heater-cooler units CONTINUE to implement the following measures to help reduce risk to patients:

  • Strictly adhere to the cleaning and disinfection instructions provided in the manufacturer’s device labeling. Ensure you have the most current version of the manufacturers’ instructions for use readily available to promote adherence.
  • Do not use tap water to rinse, fill, refill or top-off 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 patient cooling during surgical procedures 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 sterile water created through reverse osmosis is not recommended because it may promote corrosion of the metal components of the system.
  • Direct the heater-cooler’s vent exhaust away from the surgical field to mitigate the risk of aerosolizing heater-cooler tank water into the sterile field and exposing the patient.
  • Establish regular cleaning, disinfection and maintenance schedules for heater-cooler devices according to the manufacturers’ instructions to minimize the risk of bacterial growth and subsequent patient infection.
  • Develop and follow a comprehensive quality control program for maintenance, cleaning, and disinfection of heater-cooler devices. Your program may include written procedures for monitoring adherence to the program and documenting set up, cleaning, and disinfection processes before and after use.
  • Immediately remove from service heater-cooler devices that show discoloration or cloudiness in the fluid lines/circuits, which may indicate bacterial growth. Consult your hospital infection control officials to perform the appropriate follow up measures and report events of device contamination to the manufacturer and to the FDA via MedWatch.
  • 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.
  • Health care facilities should follow their internal procedures for notifying and culturing patients if they suspect infection associated with heater-cooler devices.
  • Submit a report to the manufacturer and to the FDA via MedWatch, if you suspect heater-cooler devices have been associated with patient infections.

You can read the full article on the FDA website.

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