Hothi, H;
(2022)
The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice.
Bone and Joint Open
, 3
(2)
pp. 155-157.
10.1302/2633-1462.32.BJO-2021-0144.R2.
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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.
| Type: | Article |
|---|---|
| Title: | The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1302/2633-1462.32.BJO-2021-0144.R2 |
| Publisher version: | https://doi.org/10.1302/2633-1462.32.BJO-2021-0144... |
| Language: | English |
| Additional information: | © 2022 Author(s) et al. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (CC BY-NC-ND 4.0) licence, which permits the copying and redistribution of the work only, and provided the original author and source are credited. See https://creativecommons.org/licenses/by-nc-nd/4.0/. |
| Keywords: | CE Mark, EOS, MAGEC Rods, MCGR, Medicines and Healthcare products Regulatory Agency (MHRA), alternative treatment, early onset scoliosis, general anaesthesia, lower limb, magnetically controlled growing rod, medical devices, scoliosis, spine surgeons, surgical treatment |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > UCL BEAMS UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Mechanical Engineering |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10160409 |
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