A Study of Safety and Performance Requirements for Electroconvulsive Therapy Devices.

摘要

Electroconvulsive Therapy (ECT) is used in the treatment of endogenous depression and other psychiatric disorders. While the mortality rate associated with ECT is low, a common side effect is loss of memory. Although more studies are needed on ECT stimulus parameters and neuropathological effects before an optimal standard can be established,sufficient information is available to develop a minimal safety and performance standard. Narrow,square pulses can produce seizures with less than one quarter the energy of 60Hz sinewaves,minimizing patient dosage,and are thus recommended. Other recommendations for a standard are also provided. (Portions of this document are not fully legible)