Medical safety alert issued for cardiopulmonary bypass machines

Posted: 12/06/2015


The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator for the safety of medical devices, has issued a Medical Safety Alert for hospital staff to take extra care when using cardiopulmonary bypass machines during cardiac surgery.

A recent study in Switzerland has shown that six patients who had cardiac surgery between 2008 and 2012, where cardiopulmonary bypass machines were used, developed endocarditis and/or septicaemia associated with mycobacterium avium species.

As 3,000 such surgeries took place between 2008 and 2012, the risk of infection was low. However, the outcome for the six patients infected was poor, with two of them subsequently dying.

The Swiss study suggests that a possible source of contamination is colonisation by bacteria of the water used in the heater-coolers. One specific brand of heater-cooler machine was identified as being the source of the contamination. No such implication has been made in the UK but detailed investigations are underway to assess any historic or ongoing risk to patients.

In the meantime, hospital staff are warned to take extra care with these machines to avoid the risk of contamination. The advice given includes following the manufacturer’s instructions for use at all times, in particular when cleaning, disinfecting and sterilizing these devices.

Arran Macleod, a product liability solicitor at Penningtons Manches, comments: “This type of infection should be entirely avoidable and demonstrates the importance of cleaning, disinfecting, and sterilizing hospital equipment to a high standard whenever used.

“Although the study indicates a low risk infection, the implications for any patients affected are clearly very serious and hospitals should ensure the cleanliness of their equipment to ensure the safety of the patient.”


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