Medtronic AEDs in UK device alert:
This article was originally published in Clinica
Executive Summary
Problems with the energy discharge levels of some models of Medtronic's Lifepak 12 automatic external defibrillator have led the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to post a device alert. The problem affects Adaptiv biphasic (and not monophasic) devices that have undergone software reinstallation or upgrade. This may have resulted in inadvertently resetting the device's output level to a default setting of 125 joules, instead of between 200 and 360 joules. Under the lower setting, which is below the Resuscitation Council UK guidelines, there is a greater risk of unsuccessful defibrillation. The National Defibrillator Programme, which is about to complete the installation of 3,000 AEDs in public places, no longer uses Medtronic's defibrillators, opting instead for Cardiac Science's Powerheart G3 AED (see this issue, p X).
You may also be interested in...
Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results
Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.
Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.
UK MHRA Updates Assistive Tech And Borderline Regulations
Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.