Patients undergoing heart surgery know the procedure comes with a certain amount of risks. One of those risks should not be contracting a life-threatening infection from equipment in the operation room. This is the case however for hundreds of thousands of Americans who may have been exposed to bacteria from a machine used to regulate temperature during cardiac surgery.
The device in question is known as a heater-cooler machine, and it is used during open-heart surgery to regulate the temperature of the patient’s blood and organs using water. One model produced in Germany became contaminated with nontuberculous mycobacterium (NTM), most likely during the manufacturing process. The contaminated water does not come in direct contact with patients, but vents on the machine blow the bacteria into the sterile environment. If the NTM particles land on anything being implanted into the chest or on an open wound, it could cause an infection.
The contaminated machines were used in hospitals starting in 2012. At last count, the Federal Drug Administration reports 55 patients in the United States who contracted an infection from the bacteria in the machines. In one Pennsylvania hospital, the Centers for Disease Control and Prevention found 12 patients who developed an infection, with seven deaths. Medical officials are still determining if the fatalities are directly linked to the infections, although they do feel it was a contributing factor. It is estimated that 600,000 people who had heart surgery in the past four years may have been exposed to the bacteria.
NTM is mostly found in water and soil and rarely affects a healthy person. Those with a weak immune system (common for someone having heart surgery) are more susceptible to becoming sick. While it is treatable with a specific mix of antibiotics, the infection can take anywhere from a few months to a few years to develop. Thankfully it is not contagious. Symptoms include fever, night sweats, weight loss, low energy, muscle aches, and joint pain. The combination of the slow development of the infection and symptoms common to other illnesses could lead to a misdiagnosis or a failure to diagnose the problem.
The affected machines are used in 60 percent of the 250,000 surgeries performed in the United States requiring that type of device. In June 2015, the manufacturer issued new maintenance guidelines as a safety notice to all hospitals and surgical centers that owned the machine. The CDC and the FDA are not able to directly notify hospitals and patients about the bacteria on the heater-cooler unit because they do not possess the authority to do so. It has not been subject to a recall since the machine is a vital part of potentially lifesaving surgeries. The CDC recommends hospitals keep using the device, but both doctors and patients are aware of the problem and possible complications.
Patients having surgery need to be reassured that when they undergo a procedure that there are no unnecessary risks to their health and safety. This applies to the equipment in the operating room and to doctors who are responsible for any errors. If you or a loved one is a victim of medical malpractice due to a surgical error, you need an attorney who will stand up to the medical professionals responsible for placing your health in danger. For this reason, please call the experienced and skilled attorneys at Finz & Finz, P.C., today.