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FDA: Surgical Heater-Cooler Devices Linked to Infection Risk

FDA: Surgical Heater-Cooler Devices Linked to Infection Risk

October 15, 2015 — Water heater-cooler devices commonly used in heart or lung surgery can potentially blow bacteria onto a patient and cause serious infections, according to a Safety Communication from the FDA.

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. The devices are commonly used in cardiothoracic surgery.

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.

The FDA received 32 reports between January 2010 and August 2015, including 25 reports this year. About half describe bacterial contamination of a device. The rest involve patients who developed infections, particularly Nontuberculous Mycobacteria (NTM) infections.

According to the warning:

“NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems.”

Forced-air warming blankets have also come under scrutiny for causing infections. A growing number of lawsuits blame the Bair Hugger blanket for causing deep joint infections after hip or knee replacement surgeries. Lawsuits claim hot air rising from the blanket can pick up non-sterile air off the floor and blow bacteria directly on a patient.

Do I have a Hospital Infection Lawsuit?

The Schmidt Firm, PLLC is currently accepting surgical blanket induced injury cases in all 50 states. If you or somebody you know has been diagnosed with an infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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