Heater-Cooler Devices linked to Bacterial Infections
Personal Injury Lawsuit: Heater-Cooler Devices During Surgery Linked to Deadly Bacterial Infections
Our firm is investigating potential lawsuits on behalf of individuals who contracted a bacterial infection associated with the use of a heater-cooler system during surgery.
The systems, manufactured by Sorin Group, are used to heat or cool a patient during cardiothoracic, as well as other surgeries. The devices use water tanks that regulate the temperature of warming/cooling blankets through closed circuits.
The machines have been linked to bacterial infections, which may be fatal in some patients. If you or someone you know suffered from an infection after undergoing a surgery involving a heater-cooler device, please contact Parker Waichman LLP today.
Stöckert 3T Heater-Cooler Devices Tied to Slow-Growing, Serious Infections, Leaving 500,000 Patients as Risk
More than 500,000 patients who underwent open-heart surgery in the United States since 2012 may be at risk for a deadly bacterial infection that is tied to a device that was used during their surgery, according to a federal health official announcement October 2016.
The Stöckert 3T heater-cooler devices have been available in the United States since 2006, the U.S. Food and Drug Administration (FDA) indicated, according to the Washington Post. LivaNova PLC, formerly Sorin Group Deutschland GmbH, manufactures Stöckert 3T heater-cooler devices. The agency estimates that some 2,000 devices are used in the U.S., and LivaNova PLC indicates that it has received complaints about patient deaths related to nontuberculous mycobacterium (NTM) and the devices since January 2014. In 2015, LivaNova PLC advised hospitals to update the devices cleaning instructions; however, the FDA felt that the new guidance was not sufficient in reducing infection risks. In December 2015, the agency placed an import ban on the LivaNova PLC devices; the devices are only permitted for import for demonstrated medical necessity.
The serious infection, though described by The Washington Post as rare, may lead to significant illness, even death. The bacterial infection is considered particularly menacing due to how difficult it is to detect and because patients may not exhibit symptoms or signs for months after initial exposure to the bacteria. In 2016, alone, at least 28 cases have been identified at hospitals in Iowa, Michigan, and Pennsylvania. A number of infections have also been reported in patients in Europe. In some cases, NTM was diagnosed nearly four years after surgery.
NTM bacteria are typically seen in nature where they are not dangerous; however, NTM may lead to infections in patients who have been exposed to the bacteria during invasive surgical procedures, especially when those patients have been diagnosed with weakened immune systems, The Washington Post noted. NTM infection symptoms are usually general and include fatigue, night sweats, muscle aches, unexplained fever, and weight loss. In some cases NTM has led to death. Because of the general symptoms, diagnosis may be missed or delayed, which makes NTM more difficult to treat. Because traditional treatment therapies are not effective on the slow-growing NTM, treatment involves a specific antibiotic combination.
The Stöckert 3T heater-cooler unit is a critical device used in life-saving surgeries. The device helps ensure the patient’s organs and circulating blood are maintained at a specific temperature during surgery. The Stöckert 3T heater-cooler is used in approximately 60 percent of the estimated 250,000 heart-bypass procedures conducted annually in the U.S.
In 2016, the U.S. Centers for Disease Control and Prevention (CDC) and the FDA notified physicians and patients concerning the potential link between the Stöckert 3T heater-cooler and infections. Recently completed genetic fingerprinting provided the strongest evidence, to date, that the healer-cooler machines were contaminated at a one source during production in Germany. This means that more of these machines may have been contaminated with NTM, which puts thousands more patients at risk for developing the infection.
Federal officials seek to increase awareness of NTM and the heater-cooler machine. "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," a CDC report indicated. The FDA also noted that existing information "strongly suggests" that contamination did take place at the production facility. Impacted models were manufactured prior to September 2014, according to the Washington Post. The FDA also issued an updated safety communication to assist health care providers in preventing the spread of NTM related to the use of the device.
The equipment never comes in direct contact with the patient or the patient’s blood; however, the device is constructed with a water reservoir where bacteria may grow. When the device is used during surgery, some water evaporates or is sprayed into the air in the operating room, potentially entering a patient’s open chest, according to the Washington Post.
The CDC warns patients who are experiencing post-surgical symptoms to be aware that, if other explanations are disqualified, "they and their clinicians need to think about" a potential NTM infection. There is no test to determine if a person was exposed to NTM; however, infections are diagnosed by growing and analyzing the bacteria by laboratory culture. Because of the slow-growing nature of NTM, it may take two months to rule out the infection, according to the CDC, the Washington Post wrote. Eight hospitals in four states have notified some 15,000 of their patients who underwent an open-chest procedure, as of October 2016.
1,300 People May Have Been Exposed
In October 2015, WellSpan York Hospital in Pennsylvania warned 1,300 patients that they may have been exposed to the NTM bacterial strain while undergoing open-heart surgeries between October 1, 2011 and July 24, 2015. Eight people at the hospital were infected, and four died. The deaths were linked to the infections, representatives from the hospital said, noting that other underlying medical issues may have contributed to the illnesses.
York Hospital, the Pennsylvania Department of Health, and the CDC managed questions from healthcare professionals and affected patients. A website was created for this purpose. (http://www.wellspan.org/yorkopenheart)
In an October 15, 2015 Safety Communication (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm), the FDA indicated that it received 32 reports of infections linked to heater-cooler systems, thus far. "We are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedure," the FDA stated in its communication. "NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems."
Clinical Infectious Diseases published a July 2015 report linking the devices to bacterial contamination. That same month, the FDA designated a heater-cooler system recall as a Class 2. The reason for the recall was due to "[p]otential colonization of organisms, including Mycobacteria [...] if proper disinfection and maintenance is not performed per Instructions for Use."
Four Deaths, Eight Infections at Pennsylvania Hospital
In October 2015, the FDA issued a "Safety Alert" intended to "heighten awareness about infections associated with heater-cooler devices." The agency indicated that it had received 32 reports of patient infections associated with heater-cooler devices between January 2010 and August 2015. In 2015 alone, there were 25 reports. Eight reports involved health care facilities in the United States; the remainder occurred in Europe. The infections were found to be associated the NTM bacteria.
The FDA alert indicated that, "Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient."
The New York Times reported in October 2015 that heater-cooler devices were linked to eight infections and four deaths at WellSpan York Hospital in Pennsylvania. It is not clear if these are the same American cases reported in the FDA notification. Of the eight infected, four individuals died; while it is not clear if the infections were the main cause of death, the hospital indicated in a statement that the infections were "likely a contributing factor." About 1,300 current and former patients were notified about the risk of bacterial infections associated with heater-cooler devices during open heart surgery performed between October 1, 2011 and July 24, 2015.
The heater-cooler systems received by York Hospital came with 2010 manuals that included cleaning instructions. Dr. Hal Baker, who oversees infection control at York Hospital said, "we weren't following to the letter" in reference to the instructions, according to The New York Times. Sorin Group, then-manufacturer of the heater-cooler systems, issued a safety notice in June 2015 and issued a new set of guidelines to maintain the machines. The three machines at York Hospital were replaced after the safety concerns arose, Dr. Baker said.
According to Joseph Perz, an epidemiologist at the CDC, this was the first time NTM infections had been associated with the devices, although the bacteria has caused infections during treatment for decades.