Experts Receive Rising Number Of Enquiries Related To Heart Surgery Devices

Lawyers representing heart surgery patients who developed serious infections linked to heater-cooler units used during their operations are calling for safety guidance to be reviewed, as concerns grow regarding the risks that the devices pose.

Irwin Mitchell’s specialist Product Liability team is acting for five clients and has received a growing number of enquires from those who have suffered serious illness thought to be linked to the Sorin 3T machines. 

The devices, which regulate a patient’s temperature during procedures, have been the subject of a number of medical alerts.  The Medicines and Healthcare products Regulatory Agency (MHRA) warned in December 2016 that they can become contaminated and transfer serious infection  (non- tuberculosis mycobacterium) infection whilst in use.

Two inquests have concluded with a verdict that infection originated from a Sorin 3T machine, with the Mail on Sunday earlier this year estimating that almost 50,000 Brits could have been put at risk of infection over recent years. The potentially fatal infection can take some time to develop and be diagnosed but is usually treatable with antibiotics.

Following the increase in enquiries, specialist product liability lawyers at Irwin Mitchell are now calling for all machines to be routinely tested for contamination and for disinfection guidance relating to the units to be regularly reviewed, so that everything possible is done to reduce the risks that patients can face.

Expert Opinion

“The issues which have emerged relating to these devices are hugely concerning and it is clear that action needs to be taken to ensure the units are fit for purpose. The most vulnerable patients are being exposed to a known source of infection at a time when they do not have the physical resource to fight it.

“Previous guidance has suggested that regular and proper cleaning will reduce risks, but the increase in enquiries we have seen and the recently published findings of a US study which showed 37 per cent of units tested contained the bacteria are both clearly a cause for major concern.

“Despite the problems raised in relation to these devices they are still widely in use, so we feel it is only right that steps are taken to ensure that these machines are safe.” Sallie Booth - Partner

Read more about how we can help with Sorin Stockert 3T Heater-Cooler Claims