Product News and Recalls

FDA Links Heater-Cooler Devices to Infections

heart surgery devices linked to bacteria infectionsAccording to the U.S. Food and Drug Administration (FDA), heater-cooler devices used during cardiothoracic and other medical procedures may transmit bacteria to patients and cause infections.

After examining its adverse event reporting database and reviewing relevant medical literature and information, the FDA stated it was aware that heater-cooler devices may lead to infections, specificially Nontuberculous Mycobacteria (NTM) infections. These infections primarily occur in patients undergoing cardiothoracic surgery. Though not ordinarily dangerous, NTM may cause adverse reactions in patients who are ill or already have compromised immune systems.

Heater-cooler devices include water tanks that supply temperature-controlled water to heat exchangers or blankets through controlled circuits. The FDA has found that there is a chance that water can enter other parts of the device and transmit NTM either by direct contact or through air coming out of the exhaust vent. Between January 2010 and August 2015, the FDA received 32 reports of infections associated with heater-cooler devices or bacterial heater-cooler device contamination, 25 of which were submitted in 2015.

The FDA has suggested that hospitals implement measures to reduce patients’ risk of infection, including using sterile or filtered water to rinse, fill, or refill water tanks; directing the heater-cooler’s exhaust vent away from the surgical field; and developing and following a comprehensive quality control program for maintenance, cleaning, and disinfection of heater-cooler devices. The FDA is evaluating information and collaborating with health care facilities and medical societies in an attempt to reduce the rate of NTM infections from heater-cooler devices.

Hospital patients should be able to trust in the safety of the devices used to treat them. In the event of a defective or dangerous medical device, patients can file product liability lawsuits, as many have done recently with contaminated duodenoscopes and cancer-spreading power morcellators. If you believe you or someone close to you was injured or infected by a medical device, you should contact the lawyers at Lopez McHugh today to receive a free consultation.