FDA issues safety recommendations for heater-cooler devices

Health care providers who use heater-cooler devices during cardiothoracic surgery or other procedures should consider taking additional precautions to reduce the risk of infection, the Food and Drug Administration advised yesterday, citing 32 reports of device contamination or patient infection associated with the devices since 2010. All but eight of the reports involved health care facilities in other countries. Among other actions, the agency recommends that facilities strictly adhere to the manufacturer’s current cleaning and disinfection instructions; not use tap water to rinse or fill the device’s water tank; direct the device’s vent exhaust away from the surgical field; and report suspected infections to the FDA’s MedWatch program.