October 25, 2018 — On Oct. 18, 2018, LivaNova issued a Medical Device Correction letter to inform customers of actions to take to reduce potential cardiac surgery infection associated with the Stöckert 3T Heater-Cooler Systems.
Heater-cooler devices are commonly used 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. In October 2015, the U.S. Food and Drug Administration (FDA) issued a Safety Communication to provide recommendations to help minimize patient risk of infections associated with heater-cooler devices.
Since issuing the October 2015 communication, the FDA has continued to evaluate the causes and risk factors for transmission of microbial agents associated with heater-cooler devices. The administration has worked with professional societies, public health partners and experts to develop strategies to minimize patient exposure.
To help reduce potential risk of infection during cardiac surgery, on October 18, 2018, LivaNova issued a Medical Device Correction letter to health care facilities to:
LivaNova issued the October 18 Medical Device Correction letter to healthcare facilities to:
- Provide updated instructions to monitor the concentration of hydrogen peroxide in the water circuit to verify that sufficient concentration of hydrogen peroxide is present to limit microbial growth, and to adjust the concentration of hydrogen peroxide if it drops below 100 ppm; and
- Announce the availability of a design upgrade (vacuum canister and internal sealing) that reduces the risk of potential emission of aerosols from the 3T.
Recommendations from the FDA include:
- Be aware of LivaNova's Urgent Medical Device Correction letter.
- Return the Customer Response Form included as an attachment with LivaNova's Urgent Medical Device Correction letter.
- Continue to follow the 3T operating instructions
Follow the Daily Hydrogen Peroxide Monitoring Instructions.
- Users should monitor the hydrogen peroxide concentration in the water solution on a daily basis to verify that sufficient concentration of hydrogen peroxide is present in the water circuit of the device. A decrease in hydrogen peroxide over the 7-day period until the next water change is expected, however the hydrogen peroxide concentration should remain above 100 ppm.
- Be aware of the 3T Design Upgrade.
- LivaNova has developed a vacuum canister and internal sealing design change that is intended to further reduce, but does not eliminate, the risk of airborne transmission of non-tuberculosis mycobacterium (NTM) from the 3T device.
- A LivaNova representative or local agent will contact customers to plan the upgrade of the affected products.
- 3T devices that are at the deep cleaning facility will be upgraded while there.
The FDA continues to be actively engaged with the manufacturer, healthcare facilities, and the Centers for Disease Control and Prevention (CDC), in evaluating risk and mitigation measures. The FDA is conducting its own scientific research and will provide updates, as appropriate, as new information becomes available.
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Healthcare personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
The FDA said that prompt reporting of adverse events can help the administration identify and better understand the risks associated with the use of medical devices. Healthcare providers should submit voluntary reports of infection transmission associated with heater-cooler devices or reports describing difficulty following the manufacturers' instructions for use to the agency through the Medical Device Reporting (MDR) process. If a healthcare provider suspects bacterial contamination of the heater-cooler device following use, the provider is encouraged to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
For more information: www.fda.gov, www.livanova.com