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 The agency said the LivaNova Stöckert 3T heater-cooler device used
to keep a patient’s circulating blood and organs at a specific
temperature may have been contaminated during manufacturing, putting
patients at risk of life-threatening infection.
Patients who have had open-heart surgery should seek medical care if
they are experiencing symptoms such as night sweats, muscle aches,
weight loss, fatigue or unexplained fever, CDC said.
About 60 percent of more than 250,000 heart bypass procedures in the
United States each year use the LivaNova devices, CDC said.
"Hospitals should check to see which type of heater-coolers are in
use, ensure that they're maintained according to the latest
manufacturer instructions, and alert affected patients and the
clinicians who care for them,” Michael Bell, deputy director of
CDC's Healthcare Quality Promotion division, said in a statement.
While some patients in this investigation have died, it is unclear
how many were infected and whether infection was a direct cause of
death, the agency said.
Further confounding the problem is the fact that patients exposed to
the bacteria during surgery can develop nonspecific symptoms that
can take months to develop. As a result, diagnosis of the infections
can be missed or delayed, making them more difficult to treat, CDC
said.
"We are working with regulators to develop a solution that addresses
their concerns and ensures continued clinician access to this
important device, which enables lifesaving cardiac surgery,"
London-based LivaNova said in a statement.
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The CDC and the U.S. Food and Drug Administration initially
published information about the potentially contaminated devices in
2015. Evidence suggests the bacteria, Mycobacterium chimaera,
contaminated devices during manufacturing in Germany, CDC said.
CDC said it will continue to work with the FDA and clinical
community to further evaluate and reduce risk associated with these
devices, as well as increase provider and patient awareness.
While any recall decision would come from the FDA, CDC said such a
move was not feasible, given how often the devices are used.
"Taking them all out of service at one time wouldn't really be an
option to be able to continue to do those really critical and
life-saving surgeries," a CDC spokeswoman told Reuters.
(Additional reporting by Dipika Jain in Bengaluru; Editing by
Shounak Dasguptat and Cynthia Osterman)
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