The Centers for Disease Control is warning hospitals about the infection dangers posed by some medical devices used to regulate a patient’s body temperature during open heart surgeries.
The contaminated heater-cooler devices have been linked to non-tuberculosis mycobacteria infection outbreaks in at least 16 hospitals in 10 states.
The CDC is urging hospitals to determine whether they’ve used the contaminated devices and to carry out the FDA’s recommendations for minimizing the risk of infection. The alert advises hospitals to notify surgeons and physicians with patients who have had open heart surgeries about the infection risk and to “consider institution-specific strategies for alerting patients” who may have been exposed to bacteria from the devices.
While the CDC doesn’t have the authority to require patient notification, it should recommend that hospitals let patients know about the possible infection, said Consumers Union, the policy division of Consumer Reports. The consumer group is urging hospitals and public health officials to take more aggressive action to protect patients from the infections, which can occur months and even years after exposure.
“Over one million Americans have had surgeries with these devices in recent years and shouldn’t be left in the dark about this potentially deadly infection threat,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project.
While the CDC has said that hospitals should notify doctors, it’s only calling on hospitals to consider strategies for informing patients who may have been put at risk, McGiffert said.
“Instead, hospitals should be required to notify all patients who have had surgery using these devices about the potential risk of infection,” she said. “These risks should also be disclosed in pre-surgery informed consent discussions between surgeons and patients.”
Heater-cooler devices are an important part of life-extending heart and lung operations. The devices are used in about 250,000 surgeries annually, including cardiac bypass, valve replacement, and other heart and lung operations.
The CDC said recent research found that some LivaNova PLC Stockert 3T heater-coolers “might have been contaminated during manufacturing, which could put patients at risk for life-threatening infections.”
Over the past two years, NTM infections have been reported at hospitals in Pennsylvania, Iowa, and Washington state. Hospitals, federal agencies, and at least one device manufacturer have said that a flaw in the heating and cooling devices enables them to grow, harbor, and then spray deadly bacteria through their exhaust vents, across the operating room, and into patients’ open cavities.
From 2010 to 2016, the FDA received 180 contamination reports related to heater-cooler devices from throughout the world. The reports include 45 patients in the United States who developed NTM infections and at least nine who died. The confirmed cases probably represent a small number of the actual infections, several medical specialists said.
The NTM infection can be difficult to diagnose, McGiffert said. The bacteria often grow slowly and can take as long as six years for symptoms to occur.
The CDC is advising patients who have had open heart surgery to seek medical care if they are experiencing symptoms associated with the infection, which include night sweats, muscle aches, weight loss, fatigue, or unexplained fever.