At least fifteen people have died and hundreds of others have suffered severe, life-threatening infections due to the side effect of a heart device. This device, known as a heater-cooler, is used to regulate a patient’s body temperature during surgical procedures. The Food and Drug Administration (FDA) has received 339 reports on heater-cooler devices from different hospitals throughout the U.S.
Heater-coolers are used for heart-valve replacement, heart bypass and other lung and heart operations. They are necessary in hundreds of thousands of surgical procedures annually. That said, the device has a major, deadly problem: bacteria can build up inside of it and be sprayed throughout the device’s exhaust vent. This allows for the bacteria to not only go through patient’s rooms but also for it to enter a patient’s surgical wound at a time that they are the most vulnerable since they are immune-compromised.
The deadly infection is caused by certain bacteria that is harmless in a healthy adult, but for those who have just had major surgery and are immunocompromised, it has proven deadly. The treatment for this bacteria is a therapy of several pharmaceutical drugs for many months, and when an infection has progressed too far, treatment is sometimes no longer an option.
It is the way that these heater-cooler devices are manufactured that makes them so dangerous to patients. There are current lawsuits against manufacturers of the device that claim they are unreasonably unsafe because they allow bacteria to grow and spread. The FDA released a safety warning on heater-cooler devices in 2015, and in 2016 the Centers for Disease Control and Prevention (CDC) launched another.
Although it can be difficult to prove that it is the device that causes these infections, experts say the heater-coolers are indeed spreading the fatal bacterium. Even more frightening is that experts believe that this problem is largely underreported, so the numbers may very well not reflect the gravity of the situation properly.
Heater-coolers contain tanks of water. These tanks circulate water through narrow tubes, and it is in them that bacterium starts to grow. Researchers examined heater-coolers and found that the water can reach the device’s exhaust fan, and then spread through an operating room or into a patient’s open wound. Certain heater-coolers have larger fans than others, so may increase the likelihood of expelling bacterium throughout a room.
Certain cases of infection have been studied and the CDC was able to confirm that the bacteria found in patients was the same as the bacteria found inside the heater-cooler device used during surgery. As a consequence of these findings, certain hospitals have admitted to device contamination but have not gone as far to say that the device was the cause of senseless patient deaths.
Most of the incident reports received by the FDA have to do with one model of heater-cooler device in particular: the Stockert 3T. However, the CDC along with the FDA have made it clear that its safety warnings are not brand-specific, and that other models of heater-coolers have been involved in bacterial contaminations. There are four other major manufacturers of heater-coolers, and all four have cited contamination problems through voluntary reporting to the FDA. Additionally, three of the manufacturers reported patient deaths from infection.
Both the FDA and CDC are displeased with the way that hospitals are handling their recommendations and warnings. An infection control expert with the CDC has said that hospitals lack the necessary awareness on nontuberculous myobacterial (NMT) infections, especially in respect to patients who have just had valve-replacement or bypass surgery. Time is an issue here, as well. Surgical procedures all take different lengths of time, and when a patient is exposed to a heater-cooler for a longer time period, the risk of exposure to bacterium goes up.
Time is not just an issue in respect to the surgical procedure itself, but in respect to symptoms of a bacterial infection. Sometimes it can take up to five years for the symptoms to fully present, since the bacteria is slow growing. Experts say that for this reason in particular, it is important for doctors to report to patients that they may be affected in the future and that doctors become more widely aware of the danger posed by heater-coolers as well. A panel of experts was convened, and all members agreed that informed consent forms for surgery should be altered to include a notification of the risk for infection in procedures utilizing heater-coolers.
Without increased awareness and preventive efforts, people will continue to lose their lives or fall seriously ill to an infection that can be stopped or entirely avoided. The manufacturers of the Stockert 3T claims they are working to resolve the problems with their device, but the other heater-cooler manufacturers need to catch up also. In the meantime, Consumer Reports recommend that patients who are having heart or lung surgery ask their doctor if they will be using a heater-cooler device as well as to ask if it has been tested for any kind of bacterial outbreak. It would be helpful for surgical consent forms to notify patients of this risk and for doctors to try to the best of their ability to limit a patient’s exposure to bacterium by reasonably decreasing the amount of time heater-coolers are in use.
Philadelphia Products Liability Lawyers at Galfand Berger, LLP Advocate for Victims of Medical Device Complications
If you, a family member or friend had surgery with a heater-cooler device and have experienced complications or unusual side effects, please contact your doctor’s office or hospital in regard to your injury. In order to determine whether you have a right to compensation for your injuries from this medical device, please call the knowledgeable Philadelphia personal injury attorneys at Galfand Berger, LLP. With offices located in Philadelphia, Reading and Bethlehem, we serve clients throughout Pennsylvania and New Jersey. To schedule a consultation, call us at 800-222-8792 or complete our online contact form at www.galfandberger.com.