On October 13, 2016, the Federal Centers for Disease Control and Prevention (the “CDC”) issued a health alert notice to patients and hospitals regarding the risk of infections from devices used during open heart surgery. The CDC is a federal agency under the Department of Health and Human Services. Its principal purpose is to protect public health and safety through control of harmful diseases, as well as information regarding injuries and disability. (www.cdc.gov)
The CDC encourages patients who have had open heart surgery to seek medical care if they are experiencing symptoms associated with infections such as night sweats, muscle aches, weight loss, fatigue or unexplained fever.
The device in question is a heater-cooler unit which is an essential part of these life-saving surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure. Approximately 60% of heart bypass procedures performed in the United States utilize these devices that have been associated with these infections. The CDC is warning healthcare providers and patients about the potential risk for infection and encouraged patients to seek medical attention if they are experiencing any of the aforementioned symptoms. An advisory was also issued to hospitals and healthcare providers to identify and inform patients who might have been put at risk.
The risks are thought to be low. The infection in question (NTM) is a slow growing bacteria that may take months to develop. There is no evidence that giving antibiotics just prior to or during the surgery with a potentially contaminated heater-cooler device will prevent the infection. Currently, there is no antibiotic treatment available to ward off the specific infection according to the CDC.
The organisms in question are common to water and soil. Testing conducted by the manufacturer in August of 2014 found contamination of the production line and water supply at the 3T manufacturing facility. The manufacturers recalled for instructional use only and not the device.
If you or a family member have suffered a life threatening infection as a result of open heart surgery or any other injury which may have been caused by this or any other medical device, contact Rolf Louis Patberg and the attorneys at Patberg Law Firm at 1-800-471-6880 or e-mail email@example.com to discuss any potential liability regarding this or any other medical device.