Recalls

Terumo updates cleaning instructions for heater-cooler devices

fda logo Terumo updates cleaning instructions for heater cooler devicesIn response to the Food and Drug Administration (FDA)’s ongoing investigation of non-tuberculous mycobacteria infections associated with heater-cooler devices, Terumo has revised its cleaning instructions for the Sarns TCM, TCM II, and HX2 heater-cooler devices to reduce the risk of infection to patients.

Terumo’s heater-cooler devices are temperature management systems used during surgeries to warm or cool patients as part of their care, particularly patients undergoing cardiac, vascular or cardiotherapy surgery. These devices include tanks that provide temperature-controlled water to external heat exchangers or to warming/cooling blankets through closed water circuits.

There is the potential for non-tuberculous mybacteria to grow in the water tank of heater-cooler units. While the water in these tanks does not encounter the patient’s blood or body fluids, the contaminated water droplets from the tank may disperse bacteria into the air as it escapes from the heater-cooler unit into the operating room environment. This may lead to infection or other adverse events, primarily in cardiovascular patients undergoing open-chest surgical procedures.

The FDA launched an investigation into cases of non-tuberculous mycobacteria infections linked to heater-cooler devices and is analyzing adverse event reports, medical literature and information from national and international public health agencies to mitigate the risk. Non-tuberculous mycobacteria is found in soil and water, including tap water, and is not typically harmful, but in rare cases it can cause infection in some patients.

Terumo has notified all customers with affected heater-cooler devices about the updated cleaning guides. Any adverse events related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Sources:
FDA Recall Notice
FDA Safety Communication