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The regulations overview of some medical devices that apply significant levels of energy to the human brain

Author: Soliman Alhumeidan
Publisher: 2009.
Dissertation: M. Biom. Eng. Monash University 2009
Edition/Format:   Thesis/dissertation : Thesis/dissertation : Manuscript   Archival Material : English
Summary:
The sheer increase in the number and types of medical devices has increased the risks associated with these devices. This has also necessitated stricted regulatory measures extending to the entire life span of the devices. Such a move has assumed greater significance in the light of potential serious harm, the unsafe medical devices might cause to the patients or other users. The United States Food and Drug  Read more...
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Details

Material Type: Thesis/dissertation, Manuscript
Document Type: Book, Archival Material
All Authors / Contributors: Soliman Alhumeidan
OCLC Number: 731787470
Notes: Submitted for the degree of Master of Biomedical Engineering.
Summary: leaf 2.
Description: 59 leaves : illustrations (some color) ; 30 cm
Responsibility: Soliman Alhumeidan.

Abstract:

The sheer increase in the number and types of medical devices has increased the risks associated with these devices. This has also necessitated stricted regulatory measures extending to the entire life span of the devices. Such a move has assumed greater significance in the light of potential serious harm, the unsafe medical devices might cause to the patients or other users. The United States Food and Drug Administration (FDA) have assumed the responsibility for the safety and effectiveness of a number of medical products including devices used in treating diseases or providing energy to human beings. Through its Center for Devices and Radiological Health (CDRH), FDA prescribes premarket and post-market regulation of medical devices for ensuring safety of the devices from the design stage through the entire life span of the devices. This paper reviews the device classification and clinical studies relating to certain brain stimulation devices in the context of control by the FDA. The regulatory control measures for the medical devices in general are also discussed. The thesis recommends the publication by FDA of the full document of approval to the knowledge of the public to make them aware of the complete information about the device and the manufacturers to show the conditions of approval and limitations of use while publishing the approval for any medical device to reduce the chances of potential harm by improper use of the respective devices.

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