Patients in Pennsylvania who’ve undergone open heart surgeries requiring a cardiopulmonary bypass at two hospitals may be infected with a deadly bacteria. Over 3,500 patients who underwent heart surgeries at WellSpan York Hospital in York and Penn State Hershey Medical Center in Hershey may have been exposed to Mycobacterium chimaera, a particularly invasive bacteria.
According to federal agencies, and now as alleged in lawsuits filed against the manufacturer, a surgical unit used during heart surgeries may have spread the bacteria, Mycobacterium chimaera. This specific bacteria is a species of nontuberculous mycobacterium (NTM) and is particularly difficult to diagnose due to its long incubation period. Many patients with this bacterial infection get diagnosed several months or years after the original heart surgery.
At least 1,300 patients at WellSpan York Hospital and 2,300 patients at Hershey Medical Center may have been exposed to the bacteria. As early as July 2015, WellSpan York Hospital notified the Pennsylvania Department of Health (DOH) about a cluster of patients with bacterial infections. It’s unclear when Hershey Medical Center first notified the PA DOH.
In 2015, both hospitals began notifying heart surgery patients who had surgeries between 2011 and 2015. An NTM infection is particularly invasive and often results in death. According to a May 2017 study in Emerging Infectious Diseases, Invasive Nontuberculous Mycobacterial Infections among Cardiothoracic Surgical Patients Exposed to Heater–Cooler Devices, of the 10 patients at York Hospital who were identified as having an NTM infection, 7 had died.
The Pennsylvania DOH began a field investigation in conjunction with the Centers for Disease Control to determine the source of the infections. A few months later, the CDC and the Pennsylvania DOH revealed that the bacterial infections were caused by a specific surgical device, a heater-cooler unit (HCU) used during the surgery to heat and cool a patient’s blood during the bypass procedure. The investigation revealed the presence of the bacteria in samples and swabs taken of the HCUs and operating room air samples while the HCU was ON but not when the HCU was OFF.
Read more about the infections involving Sorin/Stockert 3T Heater-Cooler units. The cluster of infections in York and Hershey, PA was no anomaly. In fact, heart surgery patients around the United States have been affected. These infections have been identified in patients in over 15 states, including Iowa and South Carolina.
Dozens of lawsuits have already been filed in a total of 17 states: Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Michigan, Minnesota, New York, North Carolina, Pennsylvania South Carolina, South Dakota, and Tennessee. Additional lawsuits are expected to be filed. Federal cases have been consolidated for handling by Judge John E. Jones in the United States District Court, Middle District of Pennsylvania.
Emerging Infectious Diseases, May 2017, Invasive Nontuberculous Mycobacterial Infections among Cardiothoracic Surgical Patients Exposed to Heater–Cooler Devices
Pennsylvania Department of Health, Winter 2016, Healthcare-Associated Infection Prevention Hospital Edition Newsletter (pdf)
Pennsylvania Department of Health, Nov. 2015, Department of Health Urges Hospitals to Increase Vigilance after Nontuberculosis Mycobaterium Infections Identified in Patients at Penn State Hershey Medical Center
Pennsylvania Department of Health, Oct. 2015, Cluster of Nontuberculous Mycobacterium Infections Identified in WellSpan York Hospital Patients
Pennsylvania Department of Health, 2015, Advisory #322, PADOH and PSA Guidance Regarding Nontuberculous Mycobacterium (NTM) Infections among Patients Undergoing Open Heart Surgeries on Cardiopulmonary Bypass (pdf)