Important Information for Open-Chest Surgery Patients

You may have heard recent news reports about potential infections linked to a medical device used during open-chest surgeries across the country and internationally. At the University of Maryland Medical Center (UMMC), patient safety and quality medical care are top priorities, and we are committed to sharing important information with our patients who have had an open-chest procedure at our hospital.

The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are investigating reports that a device used to heat and cool the blood during open-chest surgery has been linked to a rare bacterial infection caused by Mycobacterium chimaera, a type of nontuberculous mycobacteria (NTM). This particular device is used by a majority of hospitals performing these types of procedures and is a necessary, life-sustaining part of many of the open-chest procedures we perform.

These bacteria cannot be spread from person to person. They are commonly found in soil and water, and rarely make healthy people ill. According to the CDC, the risk of developing an infection following exposure to a heater/cooler device contaminated with these bacteria is very low. In hospitals where at least one infection has been identified, the risk of infection was between about 1 in 100 and 1 in 1,000 patients. To date we have no confirmed cases of M. chimaera infection.

In response to the CDC/FDA guidance, we have taken the following steps related to the use of the device under investigation:

• we follow the rigorous disinfecting protocol required by the manufacturer;
• we tested our machines for the presence of these bacteria following manufacturer's instructions and all tests have been negative;
• we are in the process of replacing these machines with a model from a different manufacturer that is not believed to pose the same potential risk of infection.

In the rare instance that an infection with these bacteria occurs, it develops very slowly and can be difficult to diagnose. It is possible to develop symptoms years after surgery, so it is important to know the symptoms to look for and discuss with your primary care doctor.

Symptoms of NTM infection include unexplained fever, weight loss, muscle aches and night sweats.

If you are not feeling well, we encourage you to call your primary healthcare provider and make them aware of this notification. Your physician can decide whether referral to an infectious disease specialist may be needed. For additional information, you or your primary care provider may also contact the Infection Prevention Department at the University of Maryland Medical Center at 410-328-7500, from 9:00 a.m. – 4:00 p.m., Monday-Friday, or you may leave a message at any time, and your call will be returned within 1 business day.

We understand that you and your family might have additional questions or concerns about this information. Enclosed with this letter is the Frequently Asked Questions document from the CDC. It is also available online at www.cdc.gov/hai/outbreaks/heater-cooler.html#quest.

As always, UMMC and the entire University of Maryland Medical System are committed to world-class patient care with an emphasis on patient safety and an exemplary patient experience.

With many thanks for your continued confidence.