The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice

Bone & Joint Open

Harry Hothi¹ 

[1] The Royal National Orthopaedic Hospital, London, UK;

关键词: MCGR;    EOS;    CE Mark;    MAGEC Rods;    alternative treatment;    surgical treatment;   

DOI  :  10.1302/2633-1462.32.BJO-2021-0144.R2

来源: DOAJ

【 摘 要 】

Abstract MAGnetic Expansion Control (MAGEC) rods are used in the surgical treatment of children with early onset scoliosis. The magnetically controlled lengthening mechanism enables rod distractions without the need for repeated invasive surgery. The CE certification of these devices was suspended in March 2021 due, primarily, to performance evidence gaps in the documents provided by the manufacturer to regulators and notified bodies. MAGEC rods are therefore not permitted for use in countries requiring CE marking. This was a survey of 18 MAGEC rod surgeons in the UK about their perception of the impact of the CE suspension on the clinical management of their patients. Unsurprisingly, virtually all perceived a negative impact, reflecting the complexity of this patient group. Reassuringly, these surgeons are highly experienced in alternative treatment methods. Cite this article: Bone Jt Open 2022;3(2):155–157.

【 授权许可】

Unknown