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The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice
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 2...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The British Editorial Society of Bone & Joint Surgery
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8886317/ https://www.ncbi.nlm.nih.gov/pubmed/35172606 http://dx.doi.org/10.1302/2633-1462.32.BJO-2021-0144.R2 |
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author | Hothi, Harry |
author_facet | Hothi, Harry |
author_sort | Hothi, Harry |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8886317 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | The British Editorial Society of Bone & Joint Surgery |
record_format | MEDLINE/PubMed |
spelling | pubmed-88863172022-03-17 The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice Hothi, Harry Bone Jt Open Spine 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. The British Editorial Society of Bone & Joint Surgery 2022-02-17 /pmc/articles/PMC8886317/ /pubmed/35172606 http://dx.doi.org/10.1302/2633-1462.32.BJO-2021-0144.R2 Text en © 2022 Author(s) et al. https://creativecommons.org/licenses/by-nc-nd/4.0/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/ |
spellingShingle | Spine Hothi, Harry The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice |
title | The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice |
title_full | The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice |
title_fullStr | The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice |
title_full_unstemmed | The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice |
title_short | The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice |
title_sort | impact and surgeon perceptions of the suspension of the ce certification of magec devices on clinical practice |
topic | Spine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8886317/ https://www.ncbi.nlm.nih.gov/pubmed/35172606 http://dx.doi.org/10.1302/2633-1462.32.BJO-2021-0144.R2 |
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