Briefcases -- Medical Devices -- STOCKERT 3T HEATER-COOLER SYSTEM- SORIN BOSTON- LivaNova, Plc (MDL 2772 Consolidation Declined By JPML April 7, 2017) (Cardiothoracic Surgery Patient Warming Devices)
STOCKERT 3T HEATER-COOLER SYSTEM- SORIN BOSTON- LivaNova, Plc (MDL 2772 Consolidation Declined By JPML April 7, 2017) (Cardiothoracic Surgery Patient Warming Devices)
SORIN STOCKERT 3T HEATER-COOLER SYSTEM
(Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in U.S. 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 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.