Cardiothoracic patients who have been infected with Mycobacterium chimaera in the United States may have been exposed to the bacteria from contaminated Stӧckert 3T Heater-Cooler System devices (Sorin Group Deustchland GmbH) used during cardiothoracic procedures, according to a safety alert from the US Food and Drug Administration (FDA).
"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 patients' procedures, and with environmental samples from the device manufacturer's production and servicing facility in Germany," the alert explains.
The study findings suggest that M chimaera infections that occurred in European patients during open-chest cardiac surgery are directly linked to "one specific heater-cooler model ― the 3T."
US experts are currently trying to ascertain whether the infections in the US patients and M chimaera isolated from the 3T are associated with M chimaera isolated in infected European patients and M chimaera previously found at the device's production and servicing facility in Germany.
In October 2015, the FDA issued a safety communication with recommendations for minimizing patient exposure to microbial agents during use of heater-cooler devices.
The Circulatory System Devices Panel of the FDA's Medical Devices Advisory Committee is meeting on June 2-3 to review data and obtain expert scientific and clinical opinion about contaminations from all heater-cooler devices.
Heater-cooler devices are used to regulate body temperature during cardiothoracic and other surgical procedures via temperature-controlled water in closed circuits. Patients are not directly exposed to this water; however, contaminated water can enter other parts of the device or aerosolize, "transmitting bacteria through the air and through the device's exhaust vent into the environment and to the patient," according to the FDA alert.
The FDA recommends that facilities that purchased and used the 3T before September 2014 be aware that the devices that were shipped from the factory may have been contaminated with M chimaera. In addition to the steps recommended in its 2015 safety communication, the FDA recommends that facilities and staff do the following:
Inform healthcare providers who have performed cardiothoracic surgeries of the risk for M chimaera infection in their patients. The risk may be higher in patients who have undergone procedures involving the introduction of a prosthetic product or material, such as a heart valve, graft, or left-ventricular assist device, or who underwent heart transplant when the device was being used.
Establish a method for patient follow-up and surveillance in cases of potential exposure, in accordance with the recommendations in the US Centers for Disease Control and Prevention's Interim Guide for the Identification of Possible Cases of Nontuberculous Mycobacterium Infections Associated With Exposure to Heater-Cooler Units, which is available online.
Facilities that purchased and used the 3T after September 2014 should continue following the FDA's recommendations in the 2015 safety communication and the manufacturer's most current instructions for the cleaning, disinfection, and maintenance to reduce patient risk.
The FDA encourages healthcare professionals and patients to report adverse events or side effects related to the use of the 3T to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online. The reporting form can also be downloaded or obtained by calling 1-800-332-1088 and returned by mail to the address listed on the form or by fax at 1-800-FDA-0178.
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Cite this: Stockert 3T Heater-Cooler Device Linked to M chimaera Infection - Medscape - Jun 03, 2016.