Recently, the Mayo Clinic has issued notifications via letter to 17,000 patients who underwent heart surgery at their facilities, warning them that a medical device used during their procedure may put them at risk for a serious infection.

The device responsible for the warning is called a cardiac heater-cooler unit.

This device is used during open-chest operations on the heart, and it is designed to regulate the temperature of patients undergoing surgery. Improved temperature regulation results in better surgical outcomes as well as less bleeding during the procedure.

Hospitals using these medical devices have been alerted that they may in fact be in possession of contaminated heater-cooler units that may cause patients to develop a serious, and potentially fatal, non-tuberculosis bacterial disease.

The microbe that was contained in the potentially contaminated heater-cooler units is known as mycobacterium abcessus. If a patient undergoes surgery using a contaminated heater-cooler, these bacteria may enter the heart surgery patient’s surgical opening.

Infections with this mycobacterium are very rare and may not be caught unless a doctor has specifically been made aware that a patient was potentially exposed.

The letter from Mayo Clinic instructs patients to contact their primary health care provider if they have any questions about the potentially contaminated heater-cooler units during their surgery or if they experience any symptoms related to the infection such as a persistent fever, night sweats, and weight loss spanning several months.

Mayo Clinic has several major campuses across the United States, including ones in Minnesota, Arizona and Florida.

Contaminated Heater-Cooler Units May Be Widespread

The hospital’s decision to send warning letters to patient was made after carefully considering the guidelines issued by the FDA and CDC in October 2016 for addressing the issues surrounding the potentially contaminated heater-cooler units. The FDA first became aware of these issues in 2015.

The FDA has said that 16 hospitals in a total of 10 different states have reported that patients have developed infections following heart surgery where the heater-cooler units were used. However, the FDA did not release the name of the hospitals or even say which states the hospitals are located in.

Despite the rare occurrence of these mycobacteria abcessus infections, more and more reports of these infections are going. Recently, the CDC linked a number of these mycobacterium outbreaks that occurred in different locations to a single source of contamination.

A European company known as LivaNova manufacturers 60% of all heater-coolers used in the United States, and its manufacturing facility was found to be contaminated.

The most recent guidelines advise hospitals that use the LivaNova units to perform testing on their machines to see if they are in fact contaminated and advise them to notify patients if the device used in their surgery was contaminated or if an outbreak of the infection occurs.

Mayo Clinic has also stated that their LivaNova heater-cooler units were not only used during heart surgery but also for patients receiving life-support care in intensive care units.

At this time, the hospital says they cannot remove all of their units immediately because there are no alternatives on the market to fill their current need. They plan to switch to a different brand as soon as possible.