Welcome to Consumer Reports Advocacy

For 85 years CR has worked for laws and policies that put consumers first. Learn more about CR’s work with policymakers, companies, and consumers to help build a fair and just marketplace at TrustCR.org

CDC Alert: Heart surgery device poses dangerous infection risk to patients

Consumers Union calls on hospitals to notify  all affected patients and to take more aggressive steps to prevent deadly infections

WASHINGTON, D.C. — The Centers for Disease Control warned hospitals today about the infection dangers posed by certain medical devices commonly used to regulate a patient’s body temperature during open heart surgeries.  The CDC’s Health Advisory was issued on the same day that Consumer Reports called attention to contaminated heater-cooler devices that have been linked to non-tuberculosis mycobacteria (NTM) infection outbreaks in at least 16 hospitals across ten states.

The CDC urged hospitals to determine whether they have used the contaminated devices and to implement 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 does not have the authority to require patient notification, it should emphatically recommend that hospitals do so, according to Consumers Union, the policy and mobilization division of Consumer Reports.  The consumer group urged hospitals and public health officials to take more aggressive action to protect patients from the infections linked to the contaminated devices, 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 is merely calling on hospitals to consider strategies for informing patients who may have been put at risk.  Instead, hospitals should be required to notify all patients who have had surgery using these devices about the potential risk of infection.  These risks should also be disclosed in pre-surgery informed consent discussions between surgeons and patients.”

Consumers Union’s Safe Patient Project is calling on hospitals and state and federal agencies to take the following steps to better protect patients from infections related to heater-cooler devices:

  • Hospitals should be required to notify all patients who have been exposed to these heater-cooler devices in the past five years about the potential infection risk. The Centers for Medicare and Medicaid Services, accreditation agencies, state licensing agencies should require hospitals to do active case findings to identify patients who have been exposed and develop notification requirements to ensure those patients are aware of the risk.
  • Hospitals should report infection outbreaks as soon as they are identified to the exposed patients, local and federal health officials, and the public.
  • The FDA should review every medical device submitted for approval or clearance for infection control issues
  • Every hospital using heater-cooling devices should take immediate steps to remove these devices so they are functioning outside of the operating room.

Heater-cooler devices are essential to life-extending heart and lung operations.  The devices are used in an estimated 250,000 surgeries each year, including cardiac bypass, valve replacement, and many other heart and lung operations.  The CDC indicated today that recent research found that some LivaNova PLC Stockert 3T heater-cooler “might have been contaminated during manufacturing which could put patients at risk for life-threatening infections.”

Over the past two years, multiple NTM infections have been reported at hospitals in Pennsylvania, Iowa, and Washington.  Hospitals, federal agencies, and at least one device manufacturer have acknowledged that a flaw in the heating and cooling devices (HCDs) enables them to grow, harbor, and then spray deadly bacteria through their exhaust vents, across the operating room, and into patients’ open cavities.

From January 1, 2010 to February 29, 2016, the FDA received 180 adverse event reports related to heater-cooler devices around the world.  The reports include 45 patients in the U.S. who developed NTM infections and at least nine who died.  Several experts have said that the confirmed cases likely represent just a fraction of the actual infections.  The NTM infection can be difficult to diagnose.  The bacteria often grow so slowly that it can take as long as six years for symptoms to emerge.   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.

Contact:  Michael McCauley, mmccauley@consumer.org, 415-902-9537 (cell) or 415-431-6747, ext. 7606 (office)