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(2002; 2 pages)
A medical device can range from a simple wooden tongue depressor or stethoscope to the most sophisticated implants or medical imaging devices. In general, a medical device is an instrument, apparatus, or machine used to prevent, diagnose or treat disease. It also serves to detect, measure, restore or modify the structure or function of the body for a given health purpose. Typically a medical device achieves its purpose without entering metabolic pathways.
Optimum safety and performance require cooperation among all involved in the life span of a medical device: the government, the manufacturer, the importer/vendor, the user and the public – each has a specific role to play in this risk management.
Many countries procure medical devices that may be substandard. Some manufacturers of medical devices may also be unaware of minimum standards. Governments that are unable to carry out pre-market review, either for imported devices or those manufactured locally, could assure regulatory compliance by taking advantage of the work of major device manufacturing countries. A priority in local regulatory development should be the establishment of vendor and product registrations.
Education and training of users, and the continued assessment of medical devices in use is as important as product control. It is critical to have access to a system for informing and collaborating with the manufacturer, vendor, all users, the public and relevant international organizations of hazards/issues related to medical devices.