The U.S. Food & Drug Administration (FDA) has released an update to its ongoing investigation into problems with heater-cooler machines, saying that it is working with specialists to minimize the risk of severe infections associated with the devices.
What’s the Problem?
June 6, 2017 – The FDA update urged hospitals and medical centers to be careful when cleaning and disinfecting heater-cooler devices, and to make sure they are using the most up-to-date version of the manufacturer’s instructions for doing so.
In October 2016, the CDC issued an advisory regarding Stockert 3T heater-cooler units manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), saying the devices “were likely contaminated with rare bacteria Mycobacterium chimaera during manufacturing.”
The agency reported that in 2015 Swiss investigators found an outbreak of M. chimaera, an aggressive strain of NTM, in at least 6 patients who had undergone open-heart surgery at the same hospital. That summer, a hospital in Pennsylvania also reported an outbreak of the same bacteria.
The Food & Drug Administration is continuing to investigate heater-cooler infections and is coordinating with healthcare facilities to identify methods of reducing risks of the devices. The agency is also working with infectious disease specialists to find ways to minimize patient exposure to NTM bacteria.