ID experts report the latest on heater-cooler device–related infections
At the 53rd annual Society of Thoracic Surgeons meeting, infectious disease experts and cardiothoracic surgeons presented the most recent evidence regarding harmful bacteria forming in heater-cooler devices used in cardiac surgery operating rooms.
Nontuberculous mycobacteria (NTM), the most frequently cited aerosolized bacteria from the heater-cooler devices (HCDs), contaminates the operating field in most reported cases. The emerging evidence regarding detecting the infections alarms regulatory agencies throughout Europe and the U.S. FDA, who organized a special conference in 2016 to address the problem.
“We are just beginning to scratch the surface, even though this research has been going on for more than 2 years,” Keith B. Allen, MD, from St. Luke’s Mid America Heart Institute and the University of Missouri-Kansas City, said in a press release.
The infections are linked to HCDs from five different manufacturers that are used in the U.S. and around the world, with 89% linked to one manufacturer.
Using the Medical Device Report database to track the incidence of infection related to HCDs revealed 339 cases between January 2010 and August 2016. There were 94 reports in which the surgical procedure involved HCDs, and 50% involved device implants, including left ventricular assist devices, prosthetic valves/rings and vascular grafts.
The infections associated with HCDs can have a latency period of up to 6 years, and the risk of infection increases with length of exposure to NTM. However, NTM, the predominant organism reported in the presented data, and Mycobacterium chimaera, the predominant isolate, are challenging to detect.
NTM takes 2 to 8 weeks to grow on mycobacterial media, Neil O. Fishman, MD, infectious disease specialist at the University of Pennsylvania Perelman School of Medicine, said in the release. Detecting the species requires sequencing that only a few labs in the U.S. can perform.
“We don’t know how long to treat these infections. At the least, most people are treated for 9 months, but some people are extending therapy to a year or 18 months,” Fishman said. “In general, the overall mortality is greater than 50%... attributed almost certainly to the delayed diagnosis.”
The FDA emphasizes adherence to manufacturer instructions for HCDs, and that all institutions use only sterile or filtered water in the units, aim HCD exhaust away from the surgical area and remove devices with signs of contamination. Both the FDA and CDC recommend removing some HCDs manufactured before September 2014 from service, and notifying patients exposed to the units since Jan. 1, 2012 about the risk of infection.
For more information:
http://www.sts.org/news/infections-related-heater-cooler-devices
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