Various news sources reported this week that approximately 1,300 patients who received open heart surgery at the WellSpan York Hospital in York, Pa., between Oct. 1, 2011 and July 24, 2014, may have been exposed to a bacterial infection. Four patients died after contracting nontuberculous mycobacterium (NTM), and four others were diagnosed with the infection.
According to the American Lung Association, NTM are naturally occurring organisms found in water and soil. An NTM lung infection occurs when a persona inhales the organism from their environment. Although most people do not become ill, susceptible individuals develop a progressive lung infection.
In a release sent out by WellSpan York Hospital this week, the hospital reports it’s notifying the open-heart surgery patients who may have been exposed to the bacteria. The release specifically mentioned a study published in July 2015 in the journal, Clinical Infectious Diseases, based on evidence from patient cases in Europe that alerted the hospital’s infectious disease specialists to a previously unknown risk of infection. According to the journal, there is a risk of infection through aerosolized NTM bacteria escaping from the heater-cooler devises that are used during open heart surgery. The European study indicated that the bacteria could pose a risk to patients who are on heart bypass machines with heater-cooler devices during surgery.
The Pennsylvania department of Health and the Centers for Disease Control and Prevention (CDC) reviewed the cases and determined that the infections identified in the patients are likely liked to the heater-cooler devices. Of the eight probable cases identified by the CDC, four of the patients had passed. Although the CDC did not directly link the deaths to the NTM infections, the hospital said in a release that it was most likely a contributing factor.
The U.S. Food and Drug Administration (FDA), issued a safety communication earlier this month warning of the NTM infections associated with the heater-cooler devices. The communication, which was issued to healthcare providers, infectious disease specialists, and others stated that through the FDA’s analysis of adverse event reports, the medical literature, and information from national and international public health agencies, “we are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.”
In the communication, the FDA recommended various safety precautions when using the devices, which can be found on the FDA website on the link above. According to CBS News, the FDA received 32 medical device reports of patient infections associated with heater-cooler devices or bacterial heater-cooler devices contamination between January 2010 and August 2015.
The CDC warns patients who have had cardiac or thoracic surgery to contact their healthcare providers immediately if they have symptoms of NTM infections, which can include fever, pain, redness, heat, or pus around the surgical incision; night sweats, joint pain, muscle pain and fatigue. The CDC said there might be a long delay between exposure to NTM and manifestation of clinical infection (up to several years).
The medical injury lawyers at Fellerman & Ciarimboli in Philadelphia and Wilkes-Barre encourage you to contact your healthcare provider with questions about possible exposure due to a heater-cooler device. If you believe you may have been the victim of medical malpractice or hospital negligence, call the medical malpractice lawyers at Fellerman & Ciarimboli today for a free consultation. Call our Philadelphia attorneys at 215-575-9237 or our Wilkes-Barre attorneys at 570-714-HURT.
With more than 40 years of combined experience, the personal injury attorneys at Fellerman & Ciarimboli strive to provide the best service to clients in Philadelphia, Northeast Pennsylvania, and throughout the Keystone State.