FDA has alerted healthcare providers to the risk of infection when using CardioQuip’s heater-cooler device during cardiothoracic procedures.
The notice, which FDA issued Wednesday, follows reports that three patients were infected with Mycobacterium abscessus at a single facility after undergoing cardiothoracic surgery.
FDA had previously received reports of contamination linked to heater-cooler devices made by the four other companies on the U.S. market. The CardioQuip reports mean all these manufacturers have now been implicated in contamination, or infections.
Heater-cooler devices enable surgeons to control the temperature of patients during surgery and, in doing so, improve health outcomes. The devices work by passing water through heat exchangers or blankets. The water is held in a tank and moved through a closed circuit, meaning it should never come into contact with the patient. However, contaminated water can become aerosolized, sending bacteria into the air of the operating room.
FDA began receiving reports of non-tuberculous mycobacteria (NTM) infections linked to the devices in 2010, leading to a 2015 warning letter to LivaNova and subsequent design changes intended to cut the risk. Regulatory communications on the topic have centered on LivaNova but FDA has also received reports of contamination linked to devices from Cincinnati Sub-Zero, Maquet and Terumo.
FDA and CardioQuip released details of three patients who developed sternal surgical site infections with a type of NTM.
The notices appear to stem from an adverse event submitted over the summer. The report describes the infection of two patients at a single facility who had sternal wound infections consistent with Mycobacterium abscessus. CardioQuip told FDA the user did not make the device available for testing "despite requests," adding that "the user facilities (sic) water source also tested positive due to current construction."
FDA said the root cause of the infection and device contamination is unknown. The agency is working with CardioQuip and the user facility to determine the factors that may have led to the infections and formulate proposals to mitigate the risk. For now, FDA is advising users to follow its advice for cutting NTM infections, which includes recommendations to not use tap water to fill heater-cooler tanks.
This story has been updated to correct the reference to patient infections linked to the devices. A prior version misstated that all manufacturers of the devices had been linked to patient infection; only CardioQuip and LivaNova fit into that category.