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Standards for medical devices: Electroconvulsive therapy machine.

Authors :
Gangadhar BN
Sreeraj VS
Sinha P
Thirthalli J
Source :
Asian journal of psychiatry [Asian J Psychiatr] 2024 Mar; Vol. 93, pp. 103938. Date of Electronic Publication: 2024 Feb 05.
Publication Year :
2024

Abstract

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.<br />Competing Interests: Declaration of Competing Interest Authors declare no conflict of interest and no relevant financial disclosures.<br /> (Copyright © 2024 Elsevier B.V. All rights reserved.)

Details

Language :
English
ISSN :
1876-2026
Volume :
93
Database :
MEDLINE
Journal :
Asian journal of psychiatry
Publication Type :
Academic Journal
Accession number :
38335891
Full Text :
https://doi.org/10.1016/j.ajp.2024.103938