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Contaminated Heater-Cooler Devices

Update: CDC has updated the notification toolkit to include frequently asked questions for hospitals notifying patients of risk from contaminated heater-cooler devices used during cardiac surgery.

Alert: CDC issued a Health Alert Notice to patients and hospitals regarding the risk of NTM infections from Stöckert heater-cooler devices used during open-heart surgery.

Patients who have had open-heart surgery and are having symptoms should seek medical care. While risk of infection is low, it is important to consult with your doctor.

Contaminated Devices Putting Open-Heart Surgery Patients at Risk

CDC encourages hospitals to take action, advises patients to seek care if ill

The Centers for Disease Control and Prevention (CDC) is warning healthcare providers and patients about the potential risk of infection from certain devices used during open heart (open-chest) surgery.

Patients who have had open heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever. This advice follows new information indicating that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, used during many of these surgeries, might have been contaminated during manufacturing which could put patients at risk for life-threatening infections.

More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year. Heater-cooler units are an essential part of these life-saving surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure. Approximately 60 percent of heart bypass procedures performed in the U.S. utilize the devices that have been associated with these infections. CDC estimates that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000. While these infections can be severe, and some patients in this investigation have died, it is unclear whether the infection was a direct cause of death. Available information suggests that patients who had valves or prosthetic products implanted are at higher risk of these infections.

CDC also released today a Health Alert Network advisory to help hospitals and healthcare providers identify and inform patients who might have been put at risk.

Click here to view the full CDC Press Release

Heater-cooler Notification Toolkit

Toolkit Overview Letter

Download Partnership Package Letter [DOCX – 410 KB]

CDC is available to assist with the process of developing documents for notifications. This section offers modifiable sample notification letters to aid in alerting clinicians and patients about the risk of infection from contaminated heater-cooler devices used during cardiac surgery.

Frequently Asked Questions for Health Departments Regarding Case Tracking of Invasive Nontuberculousius Mycobacterium Infections Following Cardiac Surgery with Exposure to Heater-cooler devices.

Download Frequently Asked Questions for Health Departments [Docx – 55 KB] 

Frequently Asked Questions for Hospitals Notifying Patients of Risk from Contaminated Heater-Cooler Devices Used During Cardiac Surgery

Download Frequently Asked Questions for Hospitals [DOCX – 23 KB]

Sample Primary Healthcare Provider Notification Letter

Download Customizable Provider Notification Letter [DOCX – 25 KB]

This sample letter is intended for the patients’ primary healthcare provider to inform him/her that the patient is receiving a notification letter. The intent is to alert healthcare providers such as; Internists, infectious disease specialists, cardiologists, cardiothoracic surgeons and other clinicians to suspect NTM infections among patients who have signs of infection and a history of open-chest cardiac surgery.

Sample Patient Notification Letter

Download Customizable Patient Notification Letter [DOCX – 23 KB]

This sample letter is intended to be sent to patients notifying them of their risk of developing an NTM infection and action steps to follow in the event of symptoms.

Sample Letter for Patients to Take to Their Primary Care Provider Letter

Download Customizable Letter for Patients [DOCX – 25 KB]

This sample letter is intended for patients to take with them when they visit their healthcare provider. The letter provides background information on the situation and to suspect NTM infections among patients who have signs of infection and a history of open-chest cardiac surgery.

Questions and Answers

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. 

Questions and Answers: Hospitals & Health Departments

Frequently Asked Questions for Health Departments Regarding Case Tracking of Invasive Nontuberculousius Mycobacterium Infections Following Cardiac Surgery with Exposure to Heater-cooler devices.

Q: CDC’s October 2016 Health Alert advises health departments to track reports from healthcare facilities about potential infections associated with heater-cooler devices. What information should be collected about these infections? Should infections be reported to the CDC?
A: Health departments should consider collecting information from healthcare facilities on any patients with invasive nontuberculous mycobacterium (NTM) infections following cardiac surgery with exposure to heater-cooler devices. Invasive NTM infection refers to an NTM-positive specimen from a normally sterile body site (such as blood, bone marrow, bone, spinal fluid, abdominal or pleural fluid), from skin, soft tissue, or drainage from a wound or abscess, or from lymph nodes. Data elements about patients with NTM infection that may be useful to obtain include information regarding demographics (e.g., age, sex, county/state of residence), diagnosis (e.g., type and location of NTM-positive specimen, NTM species, date of positive culture, date of symptom onset, clinical manifestation), exposure history (e.g., date of surgery with heater-cooler device exposure, type of surgical procedure, hospital where surgery was performed, heater-cooler device make/model/year of manufacture, implantation of prosthetic device during surgery, any risk mitigation strategies utilized in the hospital, such as moving the device outside of the operating room, if heater-cooler device has tested positive for NTM), and outcome (e.g., death, treatment success or failure).

Health departments should encourage hospitals to report all cases to the FDA via MedWatch.

Reporting of infections to CDC is voluntary. Health departments can share information regarding heater-cooler device-associated infections (absent patient identifying information) with CDC via email to Health departments may wish to review CDC/Division of Healthcare Quality Promotion Response and Outbreak Consultation Guidance [PDF – 218 KB].

Frequently Asked Questions for Hospitals Notifying Patients of Risk from Contaminated Heater-Cooler Devices Used During Cardiac Surgery

Q.How far back in time should hospitals go to notify patients?
A. Hospitals should consider notifying patients in writing if they were exposed to the Stöckert 3T devices during open-chest cardiac surgery at their institution since January 1, 2012. Hospitals that did not use the Stöckert 3T device during this entire time period should adjust the patient notification timeframe accordingly.

Q. What is the rationale for active patient outreach? Why use this time frame?
A. Based on our current understanding, the majority of patients who become infected from exposure to these devices will develop symptoms within months of their exposure. Pursuing active patient outreach using a longer time frame of approximately 4 years is expected to benefit most of the patients who have developed symptoms but have not yet been diagnosed. However, any patient who has had cardiac surgery with the Stöckert 3T device – including patients who had their surgery prior to 2012 – should be aware of this risk in the event that they develop concerning symptoms. Other forms of patient outreach (e.g., through advocacy channels or the media) will be helpful in this regard. Likewise, ongoing efforts to raise awareness among clinicians is expected to benefit all patients, regardless of when their exposure occurred.

Q. Our hospital acquired a Stöckert 3T device after September 2014.  Should we still notify patients?
A. Patients who were exposed to Stöckert 3T devices manufactured after September 2014 should also be notified. While the risks associated with these newer devices may be lower, some have tested positive for M. chimaera (see FDA Safety), possibly as a result of cross contamination from accessory devices.

Q. Our hospital conducted retrospective case-finding and we did not identify any probable cases – do we still need to send patient letters?
A. Yes, while case finding is important, negative results cannot be relied upon to determine an absence of risk.

Q. Our hospital conducted retrospective case-finding and we identified a probable case that had surgery before January 1, 2012. Do we need to extend the time period of our notification?
A. Decisions to extend notification farther back in time using individualized patient letters may best be considered on an institution-specific basis. The likelihood of identifying undetected infections diminishes with time. However, directly notifying individual patients who have been identified as having actually acquired an infection from a contaminated heater cooler device is advisable regardless of when the exposure occurred.

Q. Are only patients who have had prosthetic material implanted during their cardiac surgery at risk for M. chimaera infections? Should our hospital only notify patients who have had prosthetic material implanted?
A. Although there is some evidence that patients who have prosthetic material implanted during their open-chest cardiac procedure may be at higher risk of developing infection, heater-cooler device associated NTM infections have also occurred among patients who did not have placement of prosthetic material. Therefore, hospitals should not determine which patients to notify based on whether they have had the placement of prosthetic material during their procedures.

Q. In 2015, our hospital took measures to mitigate risk to patients by following updated manufacturer’s recommendations for disinfection and cleaning and updated guidance from the FDA. Do we still need to notify patients?
A. Yes, hospitals should still notify patients. A possible exception pertains to hospitals that have taken additional steps (e.g., moved the Stöckert 3T device out of the operating room) to eliminate patient exposure to the exhaust from these devices. These hospitals may consider not notifying patients who had surgery after these interventions if they are confident that the risk was abated.

Q. The Stöckert 3T device(s) at our hospital tested negative for M. chimaera. Should we still notify patients?
A. Yes, hospitals should still notify patients. In general, methods for sampling and microbiological testing of heater-cooler devices for M. chimaera are neither reliable nor timely. Therefore, negative test results do not necessarily indicate that devices are not presently contaminated or that they have not been contaminated in the past.

Q. How do I diagnose a patient with M. chimaera infection? How do I treat a patient with an M. chimaera infection?
A. Initial experience from clinicians indicates that these infections can be challenging to diagnose and treat. Patients have presented with a variety of clinical manifestations including endocarditis, surgical site infection, or abscess and bacteremia. Other clinical manifestations have included hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis.  Patients have also presented with granulomatous disease and have been misdiagnosed with sarcoidosis. CDC recommends that physicians consult with an infectious disease specialist for specific clinical concerns regarding these infections. CDC hosted a webinar on August 29th which included a presentation by clinical experts on the diagnosis and treatment of M. chimaera infections. 

Additional Resources

CDC MMWR – October 13, 2016 – Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United State

CDC Health Alert – October 13, 2016 – CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery

FDA Safety Alert – October 13, 2016

Interim Guide for the Identification of Possible Cases of Nontuberculous Mycobacterium Infections Associated with Exposure to Heater-Cooler Units May 13, 2016 [PDF – 210 KB]

CDC Interim Practical Guidance [PDF – 132 KB](Updated October 27, 2015)

PA Dept of Health statement