Open-Heart Surgery Important Information
For Medical Professionals
This page is intended to provide medical professionals in our region with the information you need regarding this issue. For general information about these bacterial exposures and infections related to open-heart surgery devices, please visit the "Patient" page of this website.
If you have a clinical question pertaining to one of your patients, or if you have a symptomatic patient who requires additional evaluation for potential NTM infection, please call our toll-free, 24-hour line, 1-877-467-7484, between 8:30 a.m. and 5 p.m. and request to speak with an Infectious Diseases physician.
We want to provide medical professionals in our community updated information about our recommendations related to patients who had a specific type of cardiac surgery at Penn State Milton S. Hershey Medical Center in the past four years. As a reminder, the concern is related to a rare bacterial infection caused by non-tuberculous mycobacterium (NTM) that federal agencies believe is connected to a type of device—a heater-cooler—that is used throughout the country. Out of approximately 2,300 patients, we have confirmed three cases in which a patient developed this infection after open-chest, cardiac surgery performed between Nov. 5, 2011 and Nov. 5, 2015.
As we move forward, we plan to risk-stratify patients to determine the type of follow-up that is most appropriate for the potentially exposed patients. We developed this plan based on reports about NTM infection from the literature, consensus opinion of our Infectious Diseases physicians and communication with a European investigator experienced in treating similarly situated patients abroad. There are no current published guidelines on screening patients potentially exposed to NTM but who are asymptomatic.
We have set up a dedicated clinic to evaluate these patients and have communicated information about this clinic to patients and their providers by mail. To learn more, read the full text of our letter to providers below, or call us toll-free at 1-877-467-7484.
About the Bacteria
NTM is a slow-growing organism that is commonly found in soil and water, including tap water sources. It is typically not harmful, but can occasionally lead to pulmonary disease, and uncommonly can cause infections in very debilitated or immunocompromised persons. While generally not further categorized beyond the NTM group, the specific bacteria identified was Mycobacterium chimaera, which is part of the Mycobacterium avium complex (MAC). It is treated with the same antibiotics that would be prescribed for any other MAC infection.
It is believed that the bacteria are linked to the heater-cooler devices used during open-heart surgeries. Federal health authorities are concerned that this issue may be widespread and have issued health advisories to hospitals around the country in an effort to alert them of this problem. On October 15, the U.S. Food and Drug Administration (FDA) issued a Safety Communication on this matter. In that communication, the FDA noted that the agency had received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination between January 2010 and August 2015, and 25 of those reports were provided to the FDA in 2015. To read the full FDA Safety Communication, click here. In addition, the CDC this week issued a separate advisory nationally on the issue. To read the full CDC advisory, click here.
Recommendations for Health Care Providers
If your patient does not wish to be evaluated at Penn State Hershey Medical Center, or if you have questions about this screening process, please feel free to call our toll-free, 24-hour line, 1-877-467-7484, between 8:30 a.m. and 5 p.m. and request to speak with an Infectious Diseases physician.
We will not charge patients for the cost of assessments or the tests ordered and provided by our providers or at our facilities to screen for NTM infection. If patients are unable or unwilling to receive these services from us, we will work with them to coordinate the necessary tests with their local providers. In those cases, we will reimburse providers for reasonable charges for tests and other services we have pre-approved.
- Nov. 7 provider communication
- Patient Frequently Asked Questions
- Medical Center Notifies Open-Heart Surgery Patients of Possible Infection Risk
State and Federal Resources Regarding NTM Bacteria and Heater-Cooler Units
European Resources Regarding NTM Bacteria and Infections in Open-Heart Surgery Patients
- British health officials investigate Mycobacterium chimaera infections in cardiac surgery patients
- Invasive cardiovascular infection by Mycobacterium chimaera potentially associated with heater-cooler units used during cardiac surgery
- Mycobacterium chimaera infection potentially associated with cardiac surgery, new rapid risk assessment
- Prolonged Outbreak of Mycobacterium chimaera Infection After Open-Chest Heart Surgery
Information about infections linked to heater-cooler devices at Wellspan York Hospital
Information Regarding an NTM Outbreak at Greenville Health System in South Carolina
- DHEC Statement Concerning Mycobacteria at Greenville Health System