June 02, 2016
Stӧckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections
AUDIENCE: Risk Manager, Cardiology, Surgery, Infectious Disease, Nursing
ISSUE: 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.
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.
A recently published European study 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.
BACKGROUND: 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.
RECOMMENDATIONS: 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:
o 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.
o determine a method for patient follow-up and establish patient surveillance in cases of potential exposure, per the recommendations in CDC’s Interim 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:
o 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch alert, including a link to the FDA Safety Communication, at: