Going through an open-heart surgery is frightening enough by itself, without adding a complication like a serious infection to the mix. Unfortunately, some patients have recovered successfully from surgery only to discover many months later that they contracted a potentially deadly infection because of a medical device used during the procedure.
The infections were most often caused by bacteria named “Mycobacterium chimaera (M. chimaera)” a type of nontuberculous mycobacterium (NTM) described as a “slow-grower.” Because the infection takes so long to develop, diagnosis can be difficult, and patients were often in and out of the hospital for months trying to figure out what was going on.
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), recently issued warnings relating to the heater-cooler units used during open-chest surgeries after receiving reports linking the devices to the spread of NTM infections to patients following surgery.
FDA and CDC Trace Infections to Stockert 3T Heater-Cooler Units
Stockert 3T heater-cooler devices, made by Sorin Group USA, Inc. and LivaNova Deutschland GmbH, are widely used throughout hospitals and medical centers in the U.S. They are used to maintain a patient’s body temperature during surgery. They have water tanks that provide temperature-controlled water to warming/cooling blankets and other external heat exchangers. The water never touches the patient, but the devices have fans and exhaust vents through which contaminated water can be aerosolized and circulated into the operating room.
Back in 2015, some hospitals began to report cases of patients developing infections after open-heart surgeries where heater-cooler devices were used. Investigators took air samples and swabbed the interior of the devices, and linked the infections to contaminated Stockert 3T heater-cooler units.
Similar reports came in from Europe, and on October 13, 2016, the FDA released a safety communication warning doctors and hospitals that surgery with these products had been linked with M. chimaera infections. The CDC also released a report detailing their findings, including the fact that studies had pinpointed the source of the infections as the Stockert 3T heater-cooler devices, particularly those built at one particular manufacturing site.
LivaNova Updates Cleaning Recommendations and Services
Since that time, LivaNova has updated their cleaning and disinfecting instructions for the device. On June 12, 2018, the FDA released an update on the issue, announcing the availability of “deep cleaning” services of certain Stockert 3T units in the U.S. The service is intended to help reduce the risk of NTM infections during open-chest surgeries.
Back in April 2018, LivaNova notified healthcare facilities of the new deep-cleaning service for certain devices suspected of contamination, or for cleaning those containing visible biofilms. The FDA warned that heater-cooler devices could be recontaminated, and that strict adherence to cleaning and disinfecting procedures had to be maintained.
Patients who had open-chest surgery and then developed an NTM infection may be eligible to file a lawsuit. Several patients have already done so. In February 2018, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all federally-filed Stockert 3T heater-cooler lawsuits to be centralized in the Middle District of Pennsylvania for pre-trial proceedings.