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Related Concept Videos

Electroconvulsive Therapy01:30

Electroconvulsive Therapy

39
Electroconvulsive therapy (ECT), or shock therapy, remains a critical biomedical intervention for severe, treatment-resistant depression. While its origins can be traced back to Hippocrates' observations that malaria-induced convulsions alleviated mental illness, modern ECT has evolved significantly from its earlier, more primitive applications. First introduced in 1938 by Ugo Cerletti and his colleagues, ECT involves inducing controlled seizures using electrical currents. In its early...
39

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Pupillary Response as Assessment of Effective Seizure Induction by Electroconvulsive Therapy
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Standards for medical devices: Electroconvulsive therapy machine.

Bangalore N Gangadhar1, Vanteemar S Sreeraj2, Preeti Sinha3

  • 1National Institute of Mental Health and NeuroSciences (NIMHANS), President, National Medical Commission, Pocket-14, Sector 8, Dwaraka Phase-1, New Delhi 110077, India.

Asian Journal of Psychiatry
|February 9, 2024
PubMed
Summary
This summary is machine-generated.

Establishing manufacturing standards for electroconvulsive therapy (ECT) devices is crucial for improved regulation in India. This is supported by recent medical device rules and US-FDA reclassifications, aiming to enhance device and practice standards.

Keywords:
DeviceElectroconvulsive therapyLegal regulationSafety certification

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Area of Science:

  • Medical device regulation
  • Neuromodulation technologies

Background:

  • Current regulatory landscape for electroconvulsive therapy (ECT) devices in India requires enhancement.
  • Recent global regulatory shifts, including India's Medical Device Rules 2017 (classifying ECT as Class C) and the US-FDA's 2018 reclassification of ECT devices, highlight the need for updated standards.

Purpose of the Study:

  • To advocate for the establishment of manufacturing standards for electroconvulsive devices by manufacturers.
  • To address the need for improved regulation of ECT devices and practices in India.

Main Methods:

  • Review of current regulatory frameworks in India and internationally.
  • Analysis of recent regulatory changes by Indian and US authorities concerning ECT devices.

Main Results:

  • The notification of Medical Device Rules, 2017, classifying ECT as Class C, necessitates specific manufacturing standards.
  • The US-FDA's 2018 reclassification underscores the evolving regulatory considerations for ECT devices globally.

Conclusions:

  • Establishing a unified standard for electroconvulsive devices is essential for manufacturers to ensure better regulatory compliance in India.
  • Implementing such standards will contribute to upregulating the quality of both ECT devices and the clinical practices associated with their use.