Heater-cooler devices are designed for use during surgery to maintain a patient’s body temperature. The device is used in surgeries where the heart and blood flow is stopped, such as heart transplant surgeries and cardiac bypass surgeries.
The device contains a closed water circuit, which does not contact the patient. However, bacteria living in the water circuit may contaminate the sterile environment of the operating room through the exhaust vent, leading to the potential for serious infection to the patient.
Symptoms of infection include night sweats, muscle aches, weight loss, fatigue, or unexplained fever. Treatment involves a specific antibiotic combination as routine antibiotics would not be effective against the slow-growing germ. The bacteria can be found in a variety of sites including liver, bone marrow, kidney, eye, thoracic and lumbar spine, and the pleura (membrane around the lungs) space, according to MedPage Today.
Source and Risk of Infection
The Stockert 3T heater-cooler system has come under scrutiny over the past few years, after reports of heart bypass patients developing Mycobacterium chimaera infections were traced back to the device. However, Stockert is not the only heater-cooler system being used in operating rooms across the country.
In 2012, invasive Mycobacterium chimaera infections were diagnosed in two patients who had undergone heart surgery. That same year, several outbreaks and six cases going back to 2006 were associated with the heater-cooler system and contaminated water at the University Hospital of Zurich. Surgical site infections with nontuberculous mycobacteria (NTM) after heart surgery were described but not publicly disclosed until March 2015.
The European Society of Cardiology reported in October, that 10 open-heart surgery patients were identified with Mycobacterium chimaera infections at three European hospitals. In November, Public Health England and the Medicine and Healthcare Products Regulatory Agency released guidelines to surgical centers and infection risk was identified.
National law firm Parker Waichman LLP has extensive experience and success in medical device litigation, including heater-cooler systems. The firm’s attorneys are available to answer legal questions from individuals seeking information for a potential lawsuit.
FDA and CDC Awareness and Warnings
The U.S. Food and Drug Administration (FDA) was allegedly aware of this deadly infection associated with the heater-cooler devices in 2014. However, it took the Centers for Disease Control and Prevention (CDC) one year after its United Kingdom (UK) and European counterparts to alert healthcare providers and open-heart surgery patients about the “potential risk of infection from certain devices.”
The FDA acknowledges their awareness of infections linked to the heater-cooler systems, but waited until October 2015 to issue a public warning concerning the risks. The CDC said their recommendation follows new information showing that some Stockert 3T heater-cooler devices used during many of these surgeries, “might have been contaminated during manufacturing which could put patients at risk for life-threatening infections.”
Each year in the United States, heater-cooler devices are used in over 250,000 heart bypass procedures. The Stockert device has approximately 60 percent of the heater-cooler unit market in the U.S. and contamination has been traced back to the manufacturer in Germany. FDA officials noted recently, the other 40 percent of the heater-coolers from five other manufacturers with similar design features to the Stockert system, make them susceptible to contamination, as well.
In February 2017, the FDA distributed information for patients about the “potential for Nontuberculous Mycobacteria (NTM) to be present and grow inside the heater-cooler device.” In its 2016 information letter for patient to share with their physicians, neither the CDC, nor the FDA mention the Stockert 3T device.
Normal, healthy individuals are typically not affected by NTM as the bacteria are normally present in our environment. However, the consequences can be serious in open-heart surgery patients, who are susceptible to illness. When the bacteria are in the air, they can contaminate sterile equipment, medical devices, or enter the patient’s open chest directly.
In April 2011, the FDA visited the Stockert 3T manufacturer to “address safety concerns about the heater-cooler machine,” according to a lawsuit filed in November 2016.
It is not known how many patients developed these potentially life-threatening infections since 2011, as it can in some cases take years for these infections to manifest, but it is expected there will be more lawsuits emerging.
Have You Been Injured by a Heater-Cooler
If you or someone you know has sustained injury involving a medical device, such as a Stryker Heater-Cooler System, you may be eligible for valuable compensation. Parker Waichman personal injury law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).