FDA to hold meeting on heater-cooler devices
The U.S. Food and Drug Administration will be holding an Advisory Committee Meeting on the devices linked to infections at local hospitals, according to the FDA website.
The meeting, on June 2-3, will be held to seek expert and clinical opinion related to heater-cooler device contamination, associated patient infection and potential mitigation strategies. The committee's opinion will assist the FDA in providing recommendations to minimize patient exposure to infection, according to the site.
The heater-cooler devices have been linked to infections in open-heart surgery patients in York Hospital, where five of eight infected patients have died, and Penn State Milton S. Hershey Medical Center, where two of three infected patients have died.
The FDA sent an alert to medical professionals and the general public about the potential issues with the device, but it has allowed hospitals to continue using them because "the benefits these devices provide outweigh the risk of infection," according to a FDA spokeswoman.