What is an HCD?
Specifically, the Stöckert LivaNova 3T heater-cooler unit is an HCD used in approximately 60 percent of the heart-bypass procedures conducted annually in the United States and has been associated with mounting injury and death reports and lawsuits. HCDs are used in approximately 250,000 surgeries annually in the United States, the U.S. Centers for Disease Control and Prevention (CDC) indicates.
According to the U.S. Food and Drug Administration (FDA), HCDs are stand-alone medical devices “used during cardiothoracic surgeries, as well as other medical and surgical procedures to warm or cool a patient to optimize medical care and improve patient outcomes.” The “devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. 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.” This means that, 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 Stöckert 3T heater-cooler devices, also known as the LivaNova 3T HCD, have been available in the U.S since 2006, according to the FDA. LivaNova PLC, formerly Sorin Group Deutschland GmbH, manufactures Stöckert 3T heater-cooler devices.
HCDs have been linked to serious 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.
Study Confirms LivaNova 3T Heart Surgery Device Associated with Infections
The CDC noted that reports suggest there is an association between HCDs and Mycobacterium chimaera (M.chimaera) a type of nontuburcular mycobacterium (NTM) infection in patients undergoing cardiac surgery due “potentially through the aerosolization of bacteria from contaminated water used in these devices,” according to a November 2016 QMed report.
Swiss researchers confirmed prior suspicions that there is an association between HCDs and difficult-to-eliminate mycobacterial infections. Following mounting infection reports, investigators reviewed hospital water sources and discovered M. chimaera in HCD water circuits and, specifically, in the LivaNova 3T HCD. The researchers also discovered that the bacteria was present when collected during air sampling when surgeries were conducted with the LivaNova HCDs, which suggests transmission through air particles, QMed noted in November 2016. The study appeared in the journal Infection Control & Hospital Epidemiology and confirmed the tie between HCDs utilized during heart surgery in most hospitals around the world to the virulent, slow-growing M. chimaera, according to a November 2016 QMed report. The FDA confirmed at least 12 reported deaths associated with HCDs and M. chimaera as of November 2016.
“It is surprising that a global outbreak like this could go unnoticed for years. This dangerous infection has put many patients at risk all over the world,” said Rami Sommerstein, MD, the lead author of the study of Inselspital, Bern University Hospital in Switzerland, according to QMed. “Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk,” Sommerstein pointed out in his statement. He also noted that, “The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas,” adding “That is the only way to ensure that patients are protected from this infection moving forward.” The researchers recommend hospitals, health systems, and public health authorities:
- Stringently separate contaminated HCDs from the air of critical medical areas;
- Educate clinicians on the risks and dangers of M. chimaera;
- Screen patients who have undergone open-heart surgery or heart transplantation, as well as patients exposed to ventricular assist devices and who suffer from ongoing and unexplained fevers.
Heart Surgery Device Focus of Lawsuit
A class action lawsuit was filed in February 2016 against LivaNova over allegations that thousands of patients were exposed to a potentially fatal infection through its HRDs. According to a lawsuit filed in the U.S. District Court for the Middle District of Pennsylvania over LivaNova’s Sorin 3T heater-cooler system, two men were allegedly exposed to NMT during surgery, QMed reported.
Lawsuit allegations include that, “LivaNova knew or should have known that design and/or manufacturing defects in its Sorin 3T heater-cooler system causes bacterial colonization, to which patients are exposed during surgery, thus posing a significant risk of bodily injury or death.”
In late 2015, WellSpan York Hospital and Penn State Milton S. Hershey Medical Center—where the men’s surgeries occurred, respectively—announced that 1300 and 2300 of their respective patients were exposed to NTM between 2011 and 2015. Seven of 11 patients who were diagnosed with the infection died, according to reports by the York (PA) Daily Record. Meanwhile, according to QMed, in 2015, a “York, Pennsylvania” hospital indicated that four of the eight patients infected with the M. chimaera NTB strain during heart surgeries conducted between October 1, 2011 to July 24, 2015 died.
Stöckert 3T Heater-Cooler Devices Tied to Slow-Growing, Serious Infections, Leaving 500,000 Patients
as Risk, the Focus of Increasing Federal Regulators Warnings
The FDA estimates that some 2,000 LivaNova HCD devices are used in the U.S., and LivaNova PLC indicates that it has received complaints about patient deaths related to NTM and the devices since January 2014.
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 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 notified some 15,000 of their patients who underwent an open-chest procedure, as of October 2016.
More than 500,000 patients who underwent open-heart surgery in the United States since 2012 may be at risk for the deadly bacterial infection, according to an October 2016 federal health official announcement. In its alert, the CDC indicated that LivaNova’s 3T heater-cooler devices may have been contaminated during manufacturing, potentially placing patients at risk for life-threatening infections. Also, laboratory tests completed in late 2016 by the CDC and National Jewish Health revealed that the bacteria from the 3T heater-cooler devices matches bacteria found in patients in a number of states. These results build on prior findings from Europe suggesting the devices were contaminated during manufacturing in Munich, Germany, QMed reported.
In 2016, the CDC and 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 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.
An FDA spokeswoman wrote in an email that federal regulators received 339 reports associated with infections and contamination tied to HCDs from January 2010 to August 2016. Of these reports, 298 were linked to the LivaNova’s 3T heater-cooler. Of the reports, 12 involved a patient death. Because of a potential for duplicate reports and patient clusters, actual numbers may differ. Also, because M. chimaera infection is slow growing, taking months or years to develop; symptoms are slow to appear, reporting is challenging, and people may not realize they are sick for some time and are not included in current report data.
Clinical Infectious Diseases published a July 2015 report linking the devices to bacterial contamination. That same month, the FDA designated an HCD recall as a Class 2 recall. 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.”
In an October 15, 2015 Safety Communication, intended to “heighten awareness about infections associated with heater-cooler devices,” the FDA indicated that it received 32 reports of infections linked to heater-cooler systems, between January 2010 and August 2015. “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.” The FDA alert also 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.”
In December 29, 2015, the FDA issued a warning letter to LivaNova that cited a number of deficiencies the agency discovered during an inspection that took place in August 2015 at LivaNova’s Munich plant. The FDA indicated that LivaNova’s 3T HCDs manufactured at the plant were “adulterated” and cited the manufacturer for failure to file for a Pre-Market Approval (PMA) when LivaNova changed the device’s label over new cleaning recommendations. LivaNova PLC advised hospitals to update the devices’ cleaning instructions; however, the FDA indicated that the new guidance was not sufficient in reducing infection risks.
Ultimately, the agency placed an import ban on LivaNova PLC HCDs, meaning the devices were only permitted for import for demonstrated medical necessity.
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. At that time 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)
Four Deaths, Eight Infections at Pennsylvania Hospital
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.
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