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MHRA issues medical alert on device used in cardiac surgery

Medical staff are reminded to follow manufacturer’s instructions at all times when cleaning cardiac device

Diagram of human heart

24 June 2015

The Medicines & Healthcare products Regulatory Agency (MHRA) has issued a medical safety alert relating to heater-cooler devices used in cardiac surgery.

The MHRA report that there is a low risk of mycobacterium infection, which may be down to mycobacterium-contaminated water in the heater-coolers used.

There were a small number of patients who developed endocarditis and / or septicaemia associated with Mycobacterium species following cardiac surgery.

A recent study suggested the presence of infection is a result of colonisation of the bacteria in the water used in the water-coolers.

The MHRA has urged all medical and nursing staff, who are responsible for the maintenance of devices used in cardiac surgery to follow the manufacturer’s instructions, and in particular, adhere to rules in respect of cleaning and disinfecting the devices.

The MHRA have also urged for staff to be more vigilant by reviewing, updating and following local protocols such as those in relation to water management practices, hygiene and risk assessments ensuring that devices are strictly maintained and operated safely.

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