07292017Headline:

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Andrew D'Arcy
Andrew D'Arcy
Attorney • (609) 641-6200

SURGICAL HEATER LINKED TO DEADLY INFECTION

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A medical device used in 60% of hospitals has been linked to life-threatening cardiovascular infections.  According to the Centers for Disease Control and Prevention, patients who have had valve implants or prosthetic product implants are at a higher risk of infection with a bacterial species of nontuberculous mycobacterium (NTM).  Based on the number of surgeries conducted over the past four years, an estimated 600,000 patients are at risk for a potential infection.  The CDC has confirmed infections in 28 heart surgery patients in the U.S.  Meanwhile, worldwide, at least 12 patient deaths have been reported, according to the Food and Drug Administration.

More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year.  Heater-cooler devices are an essential part of these life-saving surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure.  Heater-cooler devices consist of a water tank and a circuit system that feeds water into a surgical warming/cooling blanket or a heat-exchanger.  Water does not come in direct contact with a patient, but non-sterile water can aerosolize in the air from the exhaust vent, blowing bacteria into the operating room and onto a patient.

Following exposure to NTM through open-heart surgery, symptoms often take months to develop and so a diagnosis can be missed or delayed sometimes for years.  This makes these infections more difficult to treat.  No test can determine whether a person has been exposed to the bacteria, though a laboratory culture can diagnose an infection.  According to the CDC, the slow growing nature of the bacteria can require up to two months to rule out infection.

Patients who have had open heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue or unexplained fever.  The CDC advises that patients who have had open heart surgery since 2012 should be aware of the signs of potential infection in case they’ve been unknowingly exposed to NTM and keep in touch with their doctors for further evaluation.  The federal agency also recommended hospitals immediately assess their heater-cooler units.  Because heater-cooler devices can be extremely difficult to disinfect once contaminated with NTM, the CDC recommends hospitals continue using the device only if following the manufacturer’s latest recommendations for sterilization in between patients and proper use.