By Robert Preidt, HealthDay Reporter 
 
 (HealthDay) 
 
 THURSDAY, Oct. 13, 2016 (HealthDay News) -- Special devices used during open heart surgery may have been contaminated with bacteria that puts patients at risk for life-threatening infections, U.S. health officials warned Thursday. 
 
 Some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stockert 3T heater-cooler devices, which are used during many open heart surgeries, might have been contaminated with Mycobacterium chimaera bacteria during manufacturing, the officials said. 
 
 People who have had open heart surgery should seek medical care if they have infection-related symptoms, such as night sweats, muscle aches, weight loss, fatigue or unexplained fever, the U.S. Centers for Disease Control and Prevention said in a news release. 
 
 The agency also said that hospitals and doctors should identify and inform patients who might have been put at risk. 
 
 "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 the CDC's Division of Healthcare Quality Promotion. 
 
 "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," he urged. 
 
 Each year in the United States, there are more than 250,000 heart bypass procedures that use heater-cooler devices. These devices help keep a patient's circulating blood and organs at a specific temperature during surgery. 
 
 About 60 percent of heart bypass procedures utilize the heater-cooler devices that may have been contaminated with M. chimaera. In 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, the CDC said. 
 
 Current information suggests that patients who had valves or prosthetic products implanted have a higher risk of infection. 
 
 For more information, patients and doctors can call 800-CDC-INFO (800-232-4636). 
 
 More information 
 
 The U.S. National Heart, Lung, and Blood Institute has more on heart surgery. ||||| In the spring of 2015, investigators in Switzerland reported a cluster of six patients with invasive infection with Mycobacterium chimaera, a species of nontuberculous mycobacterium ubiquitous in soil and water. The infected patients had undergone open-heart surgery that used contaminated heater-cooler devices during extracorporeal circulation (1). In July 2015, a Pennsylvania hospital also identified a cluster of invasive nontuberculous mycobacterial infections among open-heart surgery patients. Similar to the Swiss report, a field investigation by the Pennsylvania Department of Health, with assistance from CDC, used both epidemiologic and laboratory evidence to identify an association between invasive Mycobacterium avium complex, including M. chimaera, infections and exposure to contaminated Stöckert 3T heater-cooler devices, all manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) (2). M. chimaera was described as a distinct species of M. avium complex in 2004 (3). The results of the field investigation prompted notification of approximately 1,300 potentially exposed patients.* Although heater-cooler devices are used to regulate patients’ blood temperature during cardiopulmonary bypass through water circuits that are closed, these reports suggest that aerosolized M. chimaera from the devices resulted in the invasive infections (1,2). The Food and Drug Administration (FDA) and CDC have issued alerts regarding the need to follow updated manufacturer’s instructions for use of the devices, evaluate the devices for contamination, remain vigilant for new infections, and continue to monitor reports from the United States and overseas (2). 
 
 Whole genome sequencing was completed on isolates from 11 patients and from five Stöckert 3T heater-cooler devices from hospitals in Pennsylvania and Iowa, two of the states where clusters of infections were identified (2). Samples from heater-cooler devices included swabs from the interior of the device, water drained from the devices, and air samples collected while a device was operating. Single nucleotide polymorphisms (SNPs) were identified after comparing patient and device samples against sequence data from an M. chimaera reference isolate. Results from pairwise comparisons among all sequences across a core genome of approximately 5 million base pairs revealed a maximum of 38 SNPs between any two isolates related to the outbreak investigation, versus a minimum of 2,900 SNPs between any single outbreak isolate and the epidemiologically unlinked isolate (sequence files available from the National Center for Biotechnology Information: Pennsylvania isolates Bioproject PRJNA344472; Iowa isolates Bioproject PRJNA345021; epidemiologically unlinked isolate RefSeq Assembly Accession GCF_001307335.1). 
 
 These results strongly suggest a point-source contamination of Stöckert 3T heater-cooler devices with M. chimaera. A recent report from Germany noted that preliminary typing results of M. chimaera from heater-cooler devices from three different European countries were almost identical to samples obtained from the manufacturing site, further supporting the likelihood of point-source contamination (4). Additional sequence comparisons between patient specimens and device samples obtained from facilities from various regions in the United States are ongoing. Sequence comparisons between U.S. and European samples, as well as samples from the manufacturing site, could provide additional information for evaluating the possibility of point-source contamination at the heater-cooler manufacturing site. Efforts are currently ongoing to obtain and compare European sequencing results. 
 
 Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger. Over 250,000 procedures using cardiopulmonary bypass are performed in the United States each year (5). Stöckert 3T heater-cooler devices represent approximately 60% of the U.S. market (2). CDC and FDA are continuing their efforts to increase provider and patient awareness of the risk. CDC has issued guidance on identifying patients at risk to ensure timely diagnosis and treatment of these indolent and often unrecognized infections (2). FDA is continuing to gather information, issue communications, and assess the situation from both public health and regulatory perspectives (6).† ||||| 
 
 Patients who had heart bypass procedures, such as coronary artery bypass shown here, could be at risk for a potentially deadly bacterial infection linked to a piece of commonly used equipment, health officials say. (iStock) 
 
 More than half a million patients who had open-heart surgery in the United States in the past several years could be at risk for a deadly bacterial infection linked to a device used during their operations, federal health officials said Thursday. 
 
 Although rare, such infections may cause serious illness or death. The infection is particularly insidious because it is difficult to detect. Patients may not develop symptoms or signs for months after initial exposure. 
 
 In just the past year, at least 28 cases have been identified, with hospitals in Iowa, Michigan and Pennsylvania reporting infections. Numerous infections also have been reported in patients in Europe; some were diagnosed almost four years after surgery. 
 
 The device in question is a piece of medical equipment known as a heater-cooler unit, an essential part of life-saving surgeries because it helps keep a patient’s organs and circulating blood at a specific temperature during the operation. It is used in an estimated 250,000 heart-bypass procedures in the United States every year. About 60 percent of these procedures use the German-made model that has been linked to the infections. 
 
 The bacteria, known as nontuberculous mycobacterium, or NTM, are commonly found in nature and aren’t typically harmful. But NTM can cause infections in patients who have had invasive procedures, especially when they have weakened immune systems. 
 
 Symptoms of infection are often general, such as night sweats, muscle aches, weight loss, fatigue or unexplained fever. As a result, diagnosis can be missed or delayed, making the infection more difficult to treat. Treatment involves a specific antibiotic combination because routine antibiotics won’t be effective against the slow-growing germ. 
 
 [Researchers: Medical errors now third leading cause of death in the U.S.] 
 
 During the past year, the Centers for Disease Control and Prevention and the Food and Drug Administration have notified hospitals and doctors about the potential link between the machines and infection. But recently completed genetic fingerprinting has provided the strongest evidence so far that the machines were contaminated at a single source — during their production in Germany. That means many more machines could be contaminated with the bacteria than have been identified so far, placing thousands more patients at risk. 
 
 Federal officials want to raise awareness of the issue among doctors and patients. 
 
 “Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger,” according to a CDC report released Thursday. 
 
 In a statement Thursday, the FDA said information "strongly suggests" that contamination occurred at the production facility, affecting models made before September 2014. On Thursday, the FDA issued an updated safety communication to help health care providers prevent the spread of infection related to the use of the device. 
 
 The equipment in question does not come into direct contact with the patient or the patient’s blood. But the device has a water reservoir, and bacteria can grow there. During use, some of the water evaporates or gets sprayed into the air of the operating room. It can then get into a patient’s open chest during the surgery. 
 
 [What you need to know about those deadly infections] 
 
 In U.S. hospitals where the infection has been identified, officials say the risk remains low — between 1 in 100 and 1 in 1,000, according to Mike Bell, CDC deputy director of health care quality promotion. While these infections can be severe, and some patients in this investigation have died, officials said it's unclear whether the infection was a direct cause of death. Patients who had valves or prosthetic products implanted are at higher risk of these infections, the CDC said. 
 
 Medical devices have been implicated in infections before. In 2015, lighted tubes known as duodenoscopes that are used during surgery were linked to more than two dozen outbreaks of antibiotic-resistant infections that sickened at least 250 patients in the United States and Europe. 
 
 With both pieces of equipment, health officials say design flaws didn’t take into account how difficult the equipment is to clean. 
 
 [Tainted medical scopes have sickened hundreds in U.S., Europe, investigators find] 
 
 In the case of the heater-cooler device, “some smart engineer designed it because surgeons said they need to keep this cool and that warm,” Bell said. “But no one probably said, it needs not to have a fan because it wasn’t part of the calculation. The person who wanted this machine, they weren’t thinking about maintenance and repair.” 
 
 The risk of these slow-growing infections is much lower than the more common surgical site infections, according to the CDC and FDA. And for someone facing a massive heart attack or an aneurysm that is about to rupture, the risk of NTM infection “becomes vanishingly small in comparison to the very real concrete risk that those medical emergencies pose to a patient who needs surgery,” Bell said. 
 
 But the CDC wants any patients with post-surgical symptoms to be aware that if other explanations have been ruled out, “they and their clinicians need to think about” a possible NTM infection. 
 
 [1 in 25 patients has an infection acquired during hospital stay, CDC says] 
 
 There is no test to determine whether a person has been exposed to the bacteria. Infections can be diagnosed by growing and analyzing the bacteria by laboratory culture. But the slow-growing nature of the bacteria can require up to two months to rule out the infection, the CDC said. 
 
 To date, eight hospitals in four states have notified about 15,000 of their patients who underwent an open-chest procedure, in some cases going back to 2011. 
 
 WellSpan York Hospital in York, Pa. was the first hospital in the country to identify a cluster of NTM infections in July 2015. Hospital staff, working with the CDC and the Pennsylvania health department, reviewed all the facility’s open-heart surgery cases and sent letters to about 1,300 patients who may have been exposed going back four years. 
 
 Twelve patients have infections most likely linked to the devices, including six who have died, hospital spokesman Brett Marcy said. Those who died also had complex medical conditions. 
 
 The Stöckert 3T heater-cooler devices have been available in the United States since 2006, according to the FDA. The manufacturer is LivaNova PLC, formerly Sorin Group Deutschland GmbH. The FDA estimates there are close to 2,000 devices in the United States. 
 
 The company has received complaints about patient deaths related to NTM infections and the devices since January 2014, according to the FDA. 
 
 Last year, the company notified hospitals to update cleaning instructions for the machines. But the FDA found the new guidance to be inadequate for reducing the risk of infection. In December, the agency placed an import alert on the devices, to restrict the import of the devices into the United States. 
 
 These are the six hospitals that have reported infections in Pennsylvania, Iowa and Michigan, the number of at-risk patients who were notified, the number of patients identified with NTM infections, and the dates of surgery: 
 
 • WellSpan York Hospital – 1,300 notified; 12 cases; 10/1/11 to 7/24/15 
 
 • Penn State Hershey Hospital – 2,300 notified; 5 cases; 11/5/11 to 11/5/15 
 
 • Penn Presbyterian Medical Center - 1,100 notified; 4 cases; 10/1/13 to 12/17/15 
 
 • University of Iowa – 1,500 notified; 3 cases; 1/1/12 to 1/22/16 
 
 • Mercy Medical Center in Iowa - 2,600 notified; 2 cases; 7/1/12 to 7/1/16 
 
 • Spectrum Health Medical Center in Michigan – 4,500 notified; 2 cases; 1/1/12 to 11/10/15 
 
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– A life-saving device commonly used in heart-bypass surgeries across the nation may have been contaminated during the manufacturing process, US health regulators warned on Thursday. Some LivaNova PLC Stockert 3T heater-cooler devices may have been exposed to Mycobacterium chimaera bacteria, most likely at the manufacturing plant in Germany, the Washington Post reports. According to US News, the affected heater-cooler devices are responsible for regulating a patient's blood and organ temperature during surgery. There are around 2,000 of the devices in the US, and they're used in an estimated 60% of the 250,000 bypass procedures carried out here each year, per the CDC. At least 28 infections have been traced back to the devices in the last year, with cases in Pennsylvania, Iowa, and Michigan, according to the Post. While the risk of this specific infection is low, especially compared to general rates of surgical infection, the CDC and FDA are attempting to inform hospitals whose patients might have been affected. The Post reports that in some cases years have elapsed before a patient was diagnosed with the infection, which can be fatal. Symptoms include night sweats, muscle aches, weight loss, fatigue, and fever.