Information for Open-Heart Surgery Patients About Device-Related Infection Risks - Crozer-Keystone Health System - PA

Published on November 02, 2016

Information for Open-Heart Surgery Patients About Device-Related Infection Risks

As part of Crozer-Keystone’s continuing efforts to communicate about quality and patient safety matters, we wanted to provide you with information about a device-related issue that is affecting many hospitals in this country and in Europe. The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are investigating reports that during certain open-heart procedures, the device used to warm and cool the blood called a heater-cooler unit, has been linked to a rare bacterial infection caused by Mycobacterium chimaera, a species of bacteria known as nontuberculous mycobacterium (NTM). For patients who have had one of these procedures, the chances of getting this infection are extremely low. The CDC estimates the risk to be far less than 1 percent. The heater-cooler units in question were manufactured before September 2014.

Although this type of heater-cooler is used at Crozer-Keystone, our device was manufactured after September 2014. According to the U.S. Food and Drug Administration, the FDA is not aware of any NTM patient infections associated with devices that were manufactured after this date.

To be certain, we have reviewed more than five years of microbiology history to confirm that none of our cardiac surgery patients have developed this NTM infection. In addition, we have verified that our use and maintenance of this device has met the strictest recommendations of the manufacturer, the CDC, FDA, and the Pennsylvania Department of Health.

However, while we are confident that the heater-cooler unit used in our open-heart procedures has not been involved with any NTM infections, we are taking every precaution to keep our patients and medical staff informed. This type of infection is slow-growing. It may be possible to develop symptoms months or even years after surgery, so it is important to be aware of them. These possible symptoms may include night sweats, muscle aches, unexplained weight loss, fatigue and unexplained fever. Former open-heart surgery patients who experience these symptoms or a wound infection should alert you to consider the possibility of an NTM infection.

We are posting this message because patient safety is the top priority for our health system, and we take this and all possible safety events very seriously.

Visit the CDC Advisory website for more information and frequently asked questions for patients.

If you have any specific questions at this time, feel free to contact Eric Dobkin, M.D., Chief Quality Officer and Vice President of Quality and Patient Safety, at eric.dobkin@crozer.org or 610-338-8243.

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