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CDC Issues Warning on Heart Devices That Pose Life-Threatening Risk

CDC Issues Warning on Heart Devices That Pose Life-Threatening Risk

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By    |   Thursday, 13 October 2016 03:06 PM

Some heart surgery patients may be at risk of contracting a potentially deadly infection due to a medical device that may have been contaminated during its manufacturing, government health officials warn.

The Centers for Disease Control and Prevention (CDC) issued the warning Thursday to healthcare providers and patients, alerting them that heater-cooler devices commonly used in open-heart surgeries may have been contaminated.

“It’s important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly,” said Dr. Michael Bell, deputy director of CDC’s Division of Healthcare Quality Promotion, in a statement.

He also called upon hospitals to “check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and also alert affected patients and the clinicians who care for them.”

The warning was issued on the heels of a Consumer Reports article outlining the risk and stating concern that patients were not being told about it.

The CDC said its advisory was issued after the agency received “new information” about the device, which is called the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler.

From Jan. 1, 2010, to Feb. 29, 2016, the U.S. Food and Drug Administration (FDA) received 180 incident reports related to heater-cooler devices around the world, Consumer Reports says.

The reports include 16 U.S. hospitals in 10 states where at least 45 patients were infected, and at least nine died, the magazine adds.

According to the CDC, approximately 60 percent of the 250,000 heart-bypass procedures performed in the U.S. each year utilize the device.

Heater-cooler units are an essential part of these life-saving surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedures, according to the CDC.

In hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about one in 100 and one in 1,000, the CDC note.

“While these infections can be severe, and some patients in this investigation have died, it is unclear whether the infection was a direct cause of death,” CDC officials added.

Patients who have had valves or prosthetic products implanted appear to be at highest risk of developing such infections, the agency says.

The bacteria are known as non-tuberculosis mycobacteria (NTM), a microbe common in soil and water. Although it is usually harmless, it can cause life-threatening infections if it makes its way into the chest cavity or onto the prosthetic heart valve of a surgical patient.

Last October, the CDC and the FDA each issued advisories urging healthcare facilities to be on the lookout NTM infections, and take steps to mitigate them. But the agencies did not go far enough and “stopped short of advising healthcare facilities to notify all surgical patients of the potential risk,” the consumer watchdog magazine says.

The CDC warns open heart (or open chest) surgery patients to be aware of the following symptoms and seek medical care:

  • Night sweats.
  • Muscle aches.
  • Weight loss.
  • Fatigue.
  • Unexplained fever.

CDC officials also warned that infection symptoms could take months to develop, and therefore infections could be missed or delayed – sometimes for years – making them more difficult to treat.

There is also no test to determine whether a person has been exposed to the bacteria, and it can only be detected through a laboratory culture. But because of the “slow-growing nature” of the bacteria, cases can take up to two months to confirm, according to the CDC.

The CDC also issued a Health Alert Network advisory to help hospitals and healthcare providers identify and inform patients who might have been put at risk.

But the magazine is calling upon hospitals and the FDA to take the following additional measures:

  • Hospitals should notify all patients who have been exposed to these heater-cooler devices in the past 5 years about the potential risk of infection
  • They should report infection outbreaks to exposed patients, healthcare providers, local and federal health officials, and the public as soon as they are identified.
  • The FDA should review every medical device submitted for approval or clearance for infection control issues.
  • Every hospital should take immediate steps to move the device outside of the operating room.

According to the CDC, patients who have had open-heart surgery and are concerned about symptoms they may be experiencing should contact their healthcare providers.

Clinicians or patients with questions can contact the CDC at 800-CDC-INFO (800-232-4636) or through the CDC Website.

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The government is warning that some commonly used medical devices may have been contaminated, putting patients at risk for potentially deadly infections.
CDC, FDA, heart, surgery, device, infections
Thursday, 13 October 2016 03:06 PM
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