Deadly Infections Linked to Heart Surgery Device Highlight Holes in FDA Monitoring

December 1, 2016

(Kaiser Health News) – Now hospitals, which consider the heater-cooler machines crucial in open-heart surgery, are scrambling for ways to protect patients. And authorities have urged hospitals from New Jersey to California to notify hundreds of people who underwent surgery in recent years that they might be harboring a dangerous infection. Patients have sued, claiming they were infected in Pennsylvania, Iowa, South Carolina and Quebec. Experts and patient advocates say these cases are only the latest to expose holes in the nation’s approach to spotting and responding to dangerous deficiencies in medical devices.