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Unique Device Identification. The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section ...
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the ...
Medical identification tag. A medical identification tag is a small emblem or tag worn on a bracelet, neck chain, or on the clothing bearing a message that the wearer has an important medical condition that might require immediate attention. For emergency medical providers such as paramedics and emergency physicians, medical identification tags ...
Microchip implant (human) A human microchip implant is any electronic device implanted subcutaneously (subdermally) usually via an injection. Examples include an identifying integrated circuit RFID device encased in silicate glass which is implanted in the body of a human being. This type of subdermal implant usually contains a unique ID number ...
Global Medical Device Nomenclature ( GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.
Barcode technology can help prevent medical errors by making accurate and reliable information readily available at the point-of-care. Information, such as the drug identification, medication management, infusion safety, specimen collection, etc. and any other patient care activity can be easily tracked during the patient stay.
Validation and verification are procedures that ensure that medical devices fulfil their intended purpose. Validation or verification is generally needed when a health facility acquires a new device to perform medical tests.
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