Amakuru

Kumenyekanisha ibikoresho byihariye (UDI) ni "uburyo bwihariye bwo kumenyekanisha ibikoresho by’ubuvuzi" bwashyizweho n’ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge. Ishyirwa mu bikorwa rya code yo kwiyandikisha ni ukumenya neza ibikoresho byubuvuzi byagurishijwe kandi bikoreshwa ku isoko ry’Amerika, aho byakorewe hose. . Nibimara gushyirwa mubikorwa, ibirango bya NHRIC na NDC bizavaho, kandi ibikoresho byose byubuvuzi bigomba gukoresha iyi code nshya yo kwiyandikisha nkikirangantego ku bipfunyika by’ibicuruzwa. Usibye kugaragara, UDI igomba guhaza inyandiko isanzwe no kumenyekanisha mu buryo bwikora no gufata amakuru (AIDC). Ushinzwe kuranga igikoresho agomba kandi kohereza amakuru nyayo kuri buri gicuruzwa kuri "FDA International Specialty Medical Centre". Ububiko buranga ibikoresho UDID "butuma abaturage babaza kandi bagakuramo amakuru ajyanye (harimo amakuru ava mubikorwa, gukwirakwiza kubakoresha, nibindi) ukoresheje data base, ariko data base ntabwo izatanga amakuru yumukoresha wibikoresho. 

Ahanini kode igizwe nimibare cyangwa inyuguti. Igizwe na kode iranga igikoresho (DI) hamwe na kode iranga umusaruro (PI).

Kode iranga igikoresho ni code iteganijwe iteganijwe, ikubiyemo amakuru yabakozi bashinzwe gucunga ibirango, verisiyo yihariye cyangwa icyitegererezo cyigikoresho, mugihe kode iranga ibicuruzwa idateganijwe byumwihariko, kandi ikubiyemo nimero yumusaruro wibikoresho, numero yuruhererekane, itariki yo gukora, itariki izarangiriraho nubuyobozi nkigikoresho. Kode yihariye iranga ibicuruzwa bizima.

Ibikurikira, reka tuvuge kuri GUDID, Sisitemu Yihariye yo Kumenyekanisha Ibikoresho Byihariye (GUDID), Isomero mpuzamahanga rya FDA ryihariye ryubuvuzi. Ububikoshingiro bwashyizwe ahagaragara binyuze muri sisitemu yo kubaza AccessGUDID. Ntushobora gusa kwinjiza kode ya DI ya UDI mumakuru yamakuru kurubuga rwububiko kugirango ubone amakuru yibicuruzwa, ariko urashobora kandi gushakisha ukoresheje ibiranga igikoresho icyo aricyo cyose cyubuvuzi (nkibiranga ibikoresho, isosiyete cyangwa izina ryubucuruzi, izina rusange, cyangwa icyitegererezo na verisiyo yigikoresho). ), ariko birakwiye ko tumenya ko iyi base base idatanga code ya PI kubikoresho.

Ni ukuvuga, ibisobanuro bya UDI: Ikiranga ibikoresho byihariye (UDI) ni indangamuntu ihabwa ibikoresho byubuvuzi mubuzima bwayo bwose, kandi ni "indangamuntu" yonyine murwego rwo gutanga ibicuruzwa. Kwakira kwisi yose UDI ihuriweho kandi isanzwe ni ingirakamaro mugutezimbere itangwa ryumucyo no gukora neza; ni byiza kugabanya ibiciro byo gukora; ni byiza kumenya gusangira amakuru no guhanahana amakuru; ni byiza gukurikirana ibintu bibi no kwibuka ibicuruzwa bifite inenge, kuzamura ireme rya serivisi z'ubuvuzi, no kurinda umutekano w'abarwayi.