FDA Updates Safety Communication for 3T Heater-Cooler Systems by LivaNova
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 that October 2015 communication, the FDA has continued to evaluate the causes and risk factors for transmission of microbial agents associated with heater-cooler devices and has worked with professional societies, public health partners, and experts to develop strategies to minimize patient exposure.
On October 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 3T Heater-Cooler Systems. The FDA is issuing this communication to help share the information provided by LivaNova.
In their Medical Device Correction letter to health care facilities, LivaNova recommends that facilities:
- 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.
- Announce the availability of a design upgrade (vacuum canister and internal sealing) that reduces the risk of potential emission of aerosols from the 3T.
Further, the FDA makes the following recommendations:
- 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.
Follow the link below for additional information.
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