Hospitals withdraw fluid device following aluminium exposure fears

Hospitals have withdrawn the enFlow device from use over fears it could expose patients to dangerous levels of aluminium, according to a report in The Guardian.

The device is a fluid warming system which brings blood, blood products and IV solutions up to around 40 degrees Celsius in a bid to prevent hypothermia.

The Royal Manchester Children’s Hospital suspended use of the device as a ‘precautionary measure’ and Salford Royal is also said to have to have temporarily stopped using enFlow.

The Medicines and Health Regulatory Agency (MHRA) was informed of concerns on 2 January and the matter was under investigation.

Vyaire Medical, enFlow’s manufacturer have been approached for a comment but at the time of writing haven’t replied.

Vyaire Medical are quoted in The Guardian, saying: “Since its introduction and after millions of uses worldwide, we are not aware of a single incident in a clinical setting where aluminium was observed to have been transmitted to a patient in amounts above scientifically recognised safe limits nor have there been any reported adverse events related to aluminium toxicity.

“We take our obligation to offer safe and effective products to our customers and their patients very seriously. We are reviewing this matter and working proactively with the applicable regulatory bodies to share our own data and findings. In line with our commitment to safety and quality, we will make changes to the product or its recommended usage if additional review of the data or other findings determine, in collaboration with the applicable regulatory bodies, that such steps are warranted.”