Advancing Patient Safety Surrounding Medical Devices | MDER – Dove Medical Press


There’s presently no requirement for US well being methods To make the most of the medical system distinctive system identifier (UDI) Inside The tactices of affected person care. In 2013, the US Meals and Drug Administration’s (FDA) Unique Device Identification System Rule regulated the essential first step in the direction of UDI undertakeion, specifying requirements for producer labeling of medical mannequins with a UDI.1 A UDI Consists of A system identifier (DI) that identifies producer and mannequin of the system and a manufacturing identifier (PI) that identifies lot quantity, serial quantity, expiration knowledge, and/or date of manufacture, as out there for A system. UDIs Want to be on the label and packaging of a medical system in a format That Can be digitalally seized, Similar to a barcode, As properly as to human readable.1,2 As a Outcome of of this rule, the Overwhelming majority of common- and extreme-hazard mannequins and implantable mannequins At the second are labelled with a UDI. Decrease hazard mannequins more and more are being labeled with UDIs.3

The FDA’s UDI Rule delineated a quantity of public well being goals that a UDI system might serve: discount of medical error, simplification of The mixing of system information into well being information know-how (IT) methods, extra speedy identification of mannequins with antagonistic events and enchancment of options, extra environment nice recollects, greater safety communication, strengthening of affected person and supplier information on mannequins implanted …….


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