THE Therapeutic Goods Administration has launched a product safety review into all heater-cooler devices supplied in Australia, after four confirmed cases of patient infection.
The devices are used within operating theatres and intensive care units to control the temperature of blood, with tanks providing temperature-controlled water for operation, which is not intended to come in contact with the patient or their blood.
The focus of the review is on heater-cooler devices used for cardiac bypass surgery and extracorporeal membrane oxygenation (ECMO).
Previously the TGA has published advice about the potential for water within the units to become contaminated with bacteria, most commonly non-tubercolosis myobacterium, with evidence suggesting patients are infected when bacteria becomes airborne.
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