Report Highlights Potential Problems With Medical Device

Expert product liability lawyers are urging regulatory bodies in the healthcare sector to work ‘quickly and thoroughly’ to provide answers regarding whether the enFlow medical device is safe for use, after it was suggested the system could be exposing patients to high levels of aluminium.

The Guardian has reported that concerns were raised regarding the device – which is used to warm fluids to body temperature – after it was revealed that substances which passed through it were found to contain dangerous amounts of the metal.

Such issues have led several hospitals to withdraw the use of the system manufactured by Vyaire Medical, with experts being concerned that the aluminium levels could expose babies and young children to the risk of neurological damage. 

The Medicines and Health Regulatory Agency (MHRA) was informed of the issue at the start of the year and has confirmed the issue was being actively investigated.

Specialist group actions lawyers at Irwin Mitchell have vast experience in acting for patients who have fallen ill or been injured as a result of faulty medical devices, including those affected by issues related to metal-on-metal hip implants.

Expert Opinion

“It’s very worrying to once again hear concerns being raised regarding the safety of a medical device.

“Sadly the nature of our work means we have seen numerous cases where patients have suffered as a result of problems with such devices and it is absolutely vital that everything possible is done to protect patients here.

“Safety has to come first and it is essential that the MHRA works quickly and thoroughly to get to the bottom of the issues identified. Lessons must be learned from a matter like this to ensure that patients are simply never exposed to unnecessary risks.” Matthew Newbould - Associate Solicitor