Use of potentially toxic medical device suspended by NHS hospitals

It has been reported by the Guardian that several NHS hospitals have stopped using a device that is thought to have potentially exposed patients to unacceptably high levels of aluminium. 

The Royal Manchester children’s hospital and Salford Royal have stopped using the device, and it is understood that the UK’s regulator, the Medicines and Healthcare Regulatory Authority (MHRA), commenced an investigation after they were alerted to the concerns on 2 January 2019. 
 
The device, which is called enFlow and produced by the US company Vyaire Medical, is used to bring fluids up to body temperature before they are infused into patients during surgery. However, a team of German doctors noticed that the heating element in the device was changing colour within a short time. They deduced that this change in colour suggested a chemical reaction was occurring, and when they tested some fluid that had been passed through the device they found that it contained hundreds of times the recommended safe levels of aluminium. 
 
The consequences of being exposed to aluminium are currently unclear, but it is believed that it can have potentially toxic effects in the long term. It has been linked with delayed brain development in new born babies, cognitive problems in metalworkers and Alzheimer’s disease. 
 
It is thought that the device may be in use in many more hospitals around the UK, and there is reportedly frustration that the MHRA is yet to publish formal guidance on the use of the device. 
 
Gene Matthews, partner in the Consumer Law & Product Safety Department at Leigh Day commented, “This is yet another worrying development relating to medical devices. Time and time again we have seen medical products released on to the market where they don’t appear to have been properly tested.
 
“It is particular concern that the effects of aluminium are not well understood and we may not know for many years whether patients have been harmed by this device. 
 
“It is also disappointing that the MHRA appears to have known for some time about the concerns, but is yet to produce guidance which can standardise the approach to the use – or otherwise – of this device. It cannot be right that some hospitals have suspended its use whilst others may be continuing to expose patients to this potential harm.”