June 1, 2016
- Health care providers who use 3T Heater-Cooler System
- Primary care providers who are responsible for the ongoing care of patients who have undergone cardiothoracic surgery
- Patients who have undergone cardiothoracic surgery
- Hospital staff who are responsible for operating and maintaining 3T Heater-Cooler System
Cardiothoracic Surgeons, Cardiovascular Surgeons, Orthopedic Surgeons, Neurosurgeons, General Surgeons, Anesthesiologists, Infection Control, Infectious Disease Physicians, Pediatrics, Primary Care, and Intensive Care Physicians
The Stӧckert 3T Heater-Cooler System (3T), manufactured by Sorin Group Deutschland GmbH is intended to provide temperature-controlled water to 1) oxygenator heat exchangers, 2) cardioplegia (paralysis of the heart) heat exchangers, and/or 3) warming/cooling blankets to warm or cool a patient during cardiopulmonary bypass procedures lasting six hours or less
The FDA is providing new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in patients who have undergone cardiothoracic surgeries.
Summary of Problem and Scope
Heater-cooler devices are commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient in order to optimize medical care and improve patient outcomes. Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or to aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.
In October 2015, the FDA issued a Safety Communication to provide recommendations to minimize patient risk to infections associated with heater-cooler devices. Since issuing this communication, the FDA has continued to evaluate the causes and risk factors for transmission of microbial agents associated with heater-cooler devices and is collaborating with professional societies, public health partners, and experts to develop strategies to minimize patient exposure.
A recently published European study1 describes a link between M. chimaera clinical samples from several infected cardiothoracic patients with samples from the heater-cooler devices used during these patient’s procedures, and with environmental samples from the device manufacturer’s production and servicing facility in Germany. The results of this paper suggest a direct link between the M. chimaera to which the European patients were exposed and became infected during open-chest cardiac surgery, and one specific heater-cooler model – the 3T.
M. chimaera is a type of nontuberculous mycobacterium (NTM) that may cause serious illness or death. FDA believes these NTM infections associated with the 3T are rare. However, they are difficult to detect because patients infected with M. chimaera may not develop symptoms and signs of infection for months to years after initial exposure.
Testing conducted by the manufacturer in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility. Units from this facility can be found worldwide. In response to the M. chimaera findings in August 2014, the manufacturer added cleaning and disinfection procedures to the production line in September 2014. Samples taken at the same manufacturing facility in June 2015 did not show M. chimaera on the production line, potentially eliminating the production line as a contamination source.
The FDA has received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery that involved the use of the 3T. Currently, efforts are underway in the U.S. to determine if the infections in U.S. patients and M. chimaera isolates from samples taken from the 3T are linked with M. chimaera isolates from European patients who were infected and the M. chimaera previously identified at the 3T manufacturer’s production and servicing facility in Germany.
The FDA’s recommendations are based on currently available information about M. chimaera infections associated with the 3T. During the upcoming June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting, the FDA will review available data and seek expert scientific and clinical opinion related to all heater-cooler device contaminations, associated patient infections, and mitigation strategies. As new and important information becomes available, the FDA will evaluate the information and update its recommendations, as appropriate.
Recommendations for Health Care Facilities and Staff
In addition to the recommendations provided in the 2015 Safety Communication for facilities and staff using heater-cooler devices, the FDA recommends the following:
- If your facility purchased and used the 3T prior to September 2014, be aware the units may have been shipped from the factory contaminated with M. chimaera. Such facilities should:
- inform health care providers who have performed cardiothoracic surgeries, that there is a possibility that their patients may have been infected with M. chimaera. Reports to date suggest there may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used.
- determine a method for patient follow-up and establish patient surveillance in cases of potential exposure, per the recommendations in CDC’sInterim Guide for the Identification of Possible Cases of Nontuberculous Mycobacterium Infections Associated with Exposure to Heater-Cooler Units.
- If you purchased and used the 3T after September 2014:
- continue to follow the recommendations provided in FDA’s 2015 Safety Communication and the manufacturer’s most current Instructions for Use for cleaning, disinfecting and maintenance to reduce the risk to patients.
During the upcoming June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting, the FDA will seek expert clinical opinion and recommendations for patient notification and patient follow-up procedures. Recommendations for sampling and monitoring of the 3T and other heater-cooler devices will also be discussed. As new and important information becomes available, the FDA will evaluate the information and update its recommendations, as appropriate.
Recommendations for Patients
- Be aware that:
- in the U.S., cardiopulmonary bypass procedures involve the use of a heater-cooler device.
- the FDA has received reports of patient infections associated with exposure to M. chimaera when a contaminated 3T (heater-cooler device) was used during surgery.
- there may be an increased risk of infection if you received a heart valve, graft, LVAD or any other prosthetic product/material or had a heart transplant.
- during the upcoming June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting, the FDA will seek clinical opinion about the risk of patient infection with NTM associated with the use of heater-cooler devices and mitigation strategies. As new and important information becomes available, the FDA will evaluate the information and update its recommendations, as appropriate.
- If you have undergone cardiopulmonary bypass, be aware of the possible signs and symptoms of NTM infection. These may include:
- difficulty breathing
- persistent cough or cough with blood
- redness, heat, or pus at the surgical site
- muscle pain
- joint pain
- night sweats
- weight loss
- abdominal pain
- If you have undergone a cardiopulmonary bypass procedure and are experiencing any of the signs and symptoms of NTM infection as outlined above, contact your health care provider as soon as possible.
- If you are not currently experiencing any changes in your general health, inform your health care provider during your next wellness visit that you have undergone a cardiopulmonary bypass procedure to determine if you require further testing or monitoring for possible exposure to NTM.
Additional information for patients is available on FDA’s Heater-Cooler Devices "Information for Patients" webpage.
As new and important information becomes available, the FDA will evaluate the information and update its recommendations, as appropriate.
On December 29, 2015, the FDA issued a Warning Letter to Sorin Group Deutschland GmbH for its Stӧckert 3T Heater-Cooler System after inspections conducted at facilities in Munchen, Germany and Arvada, Colorado revealed significant issues, including quality system and premarket clearance violations. Given the serious nature of the violations, the 3T devices manufactured by the Munchen facility are subject to import alert. This restricts the availability of the 3T devices to only those facilities that determine use of the device is medically necessary.
Sorin Group Deutschland GmbH initiated an ongoing corrective action for the 3T in July 2015, and has included updates to instructions for use with new cleaning instructions and instructions for determining if a device is contaminated with biofilm or NTM. Further updates to this recall are expected and will be evaluated by the FDA for their ability to further reduce infection risk. Please see the FDA medical device recall database entry for more information regarding corrective actions by the manufacturer: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&knumber=K052601
FDA continues to actively monitor this situation and will provide updates as appropriate.
Reporting Problems to the FDA
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with the use of medical devices. Health care providers should submit voluntary reports of infection transmission associated with heater-cooler devices or reports describing difficulty following the manufacturers’ instructions for use to the agency via the Medical Device Reporting (MDR) process. If a health care provider suspects bacterial contamination of the heater-cooler device following use, we encourage the health care provider to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
FDA Communications on Heater-Cooler Devices
From the Centers for Disease Control and Prevention (CDC)
Sommerstein et al. 2016. Transmission of Mycobacterium chimaera from heater-cooler units during cardiac surgery despite an ultraclean air ventilation system. Emerging Infectious Diseases.
Garvey et al. 2016. Decontamination of heater-cooler units associated with contamination by atypical mycobacteria. J. Hospital Infection.
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
1 Haller S, Hӧller C, Jacobshagen A, Hamouda O, Abu Sin, M, Monnet, DL, Plachouras D, Eckmanns, T. Contamination during production of heater-cooler units by Mycobacterium chimaera potential cause for invasive cardiovascular infections: results of an outbreak investigation in Germany, April 2015 to February 2016. Euro Surveill. 2016;21(17):pii=3025. DOI: http://dx.doi/10.2807/1560-7917.ES.2016.21.17.30215