Standards for medical devices: Electroconvulsive therapy machine.
Device
Electroconvulsive therapy
Legal regulation
Safety certification
Journal
Asian journal of psychiatry
ISSN: 1876-2026
Titre abrégé: Asian J Psychiatr
Pays: Netherlands
ID NLM: 101517820
Informations de publication
Date de publication:
05 Feb 2024
05 Feb 2024
Historique:
received:
15
12
2023
accepted:
31
01
2024
medline:
10
2
2024
pubmed:
10
2
2024
entrez:
9
2
2024
Statut:
aheadofprint
Résumé
The manuscript calls for establishing a standard for electroconvulsive devices by manufacturers for better regulation in India. This is most relevant in the context of two recent developments, (a) Notification of medical devices rules, 2017 with classification of ECT as Class C and (b) Recent change in classification of ECT devices by US-FDA in 2018. The establishment of standards would help in upregulating the standard of ECT devices as well as ECT practices.
Identifiants
pubmed: 38335891
pii: S1876-2018(24)00030-3
doi: 10.1016/j.ajp.2024.103938
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
103938Informations de copyright
Copyright © 2024 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest Authors declare no conflict of interest and no relevant financial disclosures.