- Mayo Clinic has issued a warning to 17,000 patients who underwent open-heart surgeries of a potentially life-threatening infection caused by bacteria found in certain heater-cooler models manufactured by Liva-Nova, according to Consumer Reports.
- At least one patient has contracted the infection, the nonprofit added.
- The CDC notified healthcare providers of the risk of infection from Liva-Nova's heater-coolers last month.
Hospital-acquired infections have become increasingly concerning due to the rise of antibiotic resistance. At issue with medical devices that cause these infections is hospitals lack of reporting on medical device-related adverse events, according to a recent FDA blog post.
About 60% of all open-heart surgeries in the U.S. are performed with Liva-Nova's heater-coolers. Yet CDC Division of Healthcare Quality Promotion Deputy Director Michael Bell recently told Healthcare Dive there are several steps healthcare systems can take to mitigate the risk of infection, such as ensuring the exhaust fan from the heater-cooler is not pointing directly to the surgical team or to the tray table.
The risk of acquiring the non-tuberculosis mycobacteria infection is in the 1 in 100 and 1 in 1,000 range. However, at least 28 infections had been reported in several different states as of late October.
"The Mayo Clinic's response is in line with what we'd like to see all hospitals do," Consumer Reports Safe Patient Project Deputy Director Lisa McGiffert told the nonprofit organization. "Health officials have not acted quickly or aggressively enough on this issue, and as a result, too many patients are still being exposed to risk without their knowledge or consent."