The Centers for Disease Control and Prevention has warned health care providers and patients on the potential risk of infection from contaminated heater-cooler devices that are used during open-heart surgeries.
According to the CDC report, some Stöckert 3T heater-cooler devices manufactured by LivaNova PLC could have been contaminated with bacteria named Mycobacterium chimaera during production. The infection could be fatal.
The agency noted that more than 250,000 bypass surgeries are carried out in the United States using the LivaNova heater-cooler devices every year. Furthermore, nearly 60 percent of the surgeries make use of the devices associated with the infection.
"[I]n hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000," added the CDC.
Some patients involved in the investigation have died, but whether the direct cause of death can be attributed to the infection is uncertain. However, patients who have had heart valves and prosthetic products implanted are believed to be at elevated risk of infection, the CDC said.
The CDC also recommended patients experiencing symptoms such as muscle pain, night sweats, fatigue, weight loss and unexplained fever after undergoing an open heart or bypass surgery to seek medical attention immediately.
M. chimaera, a nontuberculous mycobacterium commonly found in soil and water, rarely causes disease among healthy people. However, when the organism enters the human body through procedures such as open-heart surgery, it can cause nonspecific symptoms that usually develop after months of exposure. Therefore diagnosis of infection could be delayed for months or years, making it difficult for the patients to get appropriate treatment on time.
Since M. chimaera is not a common human pathogen there are no specific tests to detect whether a patient has been exposed to the organism. While the bacteria can still be detected through laboratory cultures, because of its slow-growing nature it might take up to two months to rule out the infection.
"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 press release. "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."
The report supports the earlier evidence from Europe that suggested that the devices were contaminated when they were manufactured in Germany.