FAQs About CDC’s National Investigation of LivaNova Sorin Heater-Cooler Devices
Recently the Centers for Disease Control and Prevention (CDC) announced an investigation of a machine produced by LivaNova PLC (also known as Sorin Group Deutschland GmbH) that is used in many U.S. hospitals during open-heart surgery. The machine heats and cools blood during surgery. Mercy Medical Center used this machine in some open-heart surgeries in the past. Once we were alerted to a potential issue, immediate steps were taken to replace this equipment with machines from another manufacturer.
The CDC’s investigation is national in scope. In an effort to be transparent, Mercy Medical Center is voluntarily notifying its patients who had open-heart surgery at our hospital about a potential infection risk related to the LivaNova machine. Mercy has conducted an extensive review of ALL patients that might have been affected by this issue and found NO patients who have tested positive for this infection. However, we are educating patients and notifying clinicians about the CDC national investigation.
The CDC is investigating reports that the LivaNova machine has been linked to a rare bacterial infection caused by Mycobacterium chimaera, a type of bacteria known as nontuberculous mycobacterium (NTM). The CDC has issued guidance to all U.S. hospitals that used this machine, and Mercy is following those recommendations.
Read the CDC Notification Toolkit on contaminated heater-cooler devices >>
These devices are believed to have potentially become contaminated during the manufacturing process. Mercy has diligently followed all recommended manufacturers guidelines for cleaning and disinfecting the equipment. The CDC has determined these measures may not be sufficient to eliminate contamination with NTM. For patients who have had one of these surgeries, the chances of getting this infection are very low.CDC estimates the risk to be less than 1 percent.
Of the 2000 patients at Mercy Medical Center who have had open heart surgery, we are not aware of any patient(s) who have developed this infection. This infection is very slow- growing and difficult to diagnose. Most infections will develop within four months of exposure, but infections may occur up to approximately four years following surgery. For this reason, it is important to know the symptoms to look for. Discuss any symptoms or questions you may have with your primary care doctor. This infection cannot be spread from person-to-person. Symptoms of an NTM infection may include: night sweats, muscle aches, weight loss, fatigue and/or unexplained fever.
We understand that you and your family may have additional questions or concerns about this information. To help answer them, you may contact our hotline at 330-580-4732.
Frequently Asked Questions
Q. What is the risk of infection?
A. Overall, the risk is thought to be 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. Initial information suggests that patients who had prosthetic implants are at higher risk. It is possible that not all of the devices introduced these bacteria into the operating room or exposed patients.
Q. How long does it usually take for these infections to show up?
A. NTM are slow-growing bacteria and infections may take months to develop. Cases associated with this device have been diagnosed within months and up to several years after an open-heart surgery involving heater-cooler unit exposure.
Q. Can a person who develops one of these NTM infections spread it to others, such as family members?
A. No, the bacteria cannot be spread to others from an infected patient. Also, it is important to keep in mind that NTM is common in soil and water but rarely makes healthy people sick.
Q. Should everyone who was exposed to these devices during open-heart surgery receive antibiotics just in case?
A. The risk that patients will develop an infection following exposure to a contaminated heater-cooler unit is very low. There is also no evidence that giving antibiotics just prior or during surgery with a potentially contaminated heater-cooler device will prevent infection. Although antibiotics can be life-saving drugs, there is no antibiotic treatment available to ward off this specific infection and antibiotics are also not without risk themselves. Antibiotics put patients at risk for allergic reactions and a potentially deadly diarrheal infection caused by the bacteria Clostridium difficile. Antibiotic use is also a key driver of antibiotic resistance, which can put patients at risk for antibiotic-resistant infections later.
Q. How long does it take to find out if an infection is being caused by NTM?
A. M. chimaera is a slow-growing species of NTM that can take eight weeks and sometimes longer to grow and allow final identification.
Q. Why are these infections so deadly?
Symptoms of infection can take months to develop, and are often general and nonspecific. As a result, diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat. Clinicians may not immediately consider an NTM diagnosis. Delayed diagnosis can result in more widespread disease in a patient. This, combined with underlying health problems such as heart disease can make these infections difficult to treat.
Q. How do you think the devices got contaminated?
A. NTM is common in water and soil. Recent CDC findings are consistent with previous reports suggesting that the heater-cooler units were contaminated during production. Testing conducted by the manufacturer in August of 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility.
Q. Have these devices ever been recalled? Why aren’t they being recalled now?
A. In 2015, the manufacturer recalled the instructions for use, but not the device itself. Information provided by the manufacturer reminded users that while water from the device itself is not intended to contact the patient directly, under certain circumstances, due to fluid leakage and/or aerosolization, NTM could reach a patient’s surgical site. Heater-cooler devices are critical for life-saving surgery. A national recall could result in patients not getting life-saving surgeries that are needed now.