Class 1 Recall: UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) St?ckert 3T Heater-Cooler System: FDA Safety Communication
The FDA is updating its June 1, 2016 Safety Communication to provide new information aboutMycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations to help prevent the spread of infection related to the use of these devices.
October 13, 2016
Medical Specialties: Cardiothoracic Surgeons, Cardiovascular Surgeons, Orthopedic Surgeons, Neurosurgeons, General Surgeons, Anesthesiologists, Infection Control, Infectious Disease Physicians, Pediatrics, Primary Care, and Intensive Care Physicians
Product: The St?ckert 3T Heater-Cooler System (3T), manufactured by LivaNova PLC (formerly 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.
Purpose: The FDA is updating its June 1, 2016 Safety Communication to provide new information aboutMycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations to help prevent the spread of infection related to the use of these devices.
As the FDA continues to investigate infections associated with the 3T, we believe health care facilities should take additional steps to help mitigate the risk of infection associated with the use of these devices
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 have 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 and 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 help minimize patient risk of infections associated with heater-cooler devices. Since issuing that communication, the FDA has continued to evaluate the causes and risk factors for transmission of microbial agents associated with heater-cooler devices and has collaborated with professional societies, public health partners, and experts to develop strategies to minimize patient exposure.
A European study1 published in April 2016 describes a link between M. chimaera clinical samples from several European infected cardiothoracic patients, samples from the heater-cooler devices used during these patient's procedures, and 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 that infected European patients during open-chest cardiac surgery, and the M. chimaera isolated from the 3T heater-cooler model utilized during these patients' surgeries.
M. chimaera is a type of nontuberculous mycobacterium (NTM) classified as a slow grower. M. chimaera may cause serious illness or death. The FDA believes M. chimaera infections associated with the 3T are rare. However, they are difficult to detect because infected patients may not develop symptoms or signs of infection for months to years after initial exposure.
On June 1, 2016, the FDA issued a Safety Communication specific to M. chimaera infections associated with the use of the 3T. Testing conducted by the manufacturer in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility. The 3T devices manufactured at this facility were distributed 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, by the German Regulatory Authorities in July 2015 did not show M. chimaera, potentially indicating the contamination at the manufacturing facility had been resolved. Although the manufacturer of 3T devices added cleaning and disinfection procedures to the production line in September 2014, the FDA is now aware of some 3T devices manufactured after September 2014 which have tested positive for M. chimaera. It has not been confirmed whether these devices were contaminated at the manufacturing facility or became contaminated at the user facility. To date, the FDA is not aware of M. chimaera patient infections associated with 3T devices that were manufactured after September 2014.
The June 1, 2016 Safety Communication also stated the FDA received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery that involved use of the 3T devices. Each of those reports related to 3T devices that were manufactured prior to September 2014. The Centers for Disease Control and Prevention (CDC) in conjunction with National Jewish Health has performed whole genome sequencing on clinical isolates from infected patients and samples taken from the 3T devices from hospitals representing geographically distinct regions within the U.S. (Pennsylvania and Iowa) where clusters of patient infections with M. chimaera were identified. Each of the isolates tested were associated with devices manufactured before September 2014. Samples of the water drained from the 3T devices and air samples collected while the devices were in operation were also tested. The results obtained strongly suggest that the tested 3T devices had a common source of M. chimaera contamination. Sequence comparisons between U.S. and European Union (EU) samples, as well as samples from the manufacturing site, would provide additional information in evaluating the potential for point source contamination at the production site. However, EU sequencing results have not been shared to date.
As new information becomes available, the FDA will evaluate the information and update its recommendations, as appropriate.
UPDATED Recommendations for Health Care Facilities and Staff:
If your facility uses 3T devices, you should:
If your facility has 3T devices manufactured prior to September 2014, you should:
If your facility has 3T devices manufactured after September 2014, you should:
The FDA recommends facilities and staff using heater-cooler units CONTINUE to implement the following measures to help reduce risk to patients:
Recommendations for Patients:
Additional information for patients is available on FDA's Heater-Cooler Devices "Information for Patients" webpage.
On December 29, 2015, the FDA issued a Warning Letter to LivaNova PLC (formerly Sorin Group Deutschland GmbH) for its St?ckert 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.
In June 2016, the FDA convened the Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting and received expert clinical opinion and recommendations for patient notification and patient follow-up procedures. The panel also discussed recommendations for sampling and monitoring of the 3T and other heater-cooler devices, including regular visual monitoring of contamination within the water circuit, replacement of accessories (e.g. tubing) on a regular basis, and testing for water quality to assure adequate disinfection procedures are being performed. These recommendations are included in this Safety Communication.
The FDA continues to be actively engaged with the manufacturer, health care facilities and the CDC in evaluating risk and mitigation measures and will provide updates, as appropriate, as new information becomes available.