Izindaba

I-Unique device identification (UDI) "iwuhlelo lokuhlonza idivayisi yezokwelapha ekhethekile" olusungulwe i-US Food and Drug Administration. Ukuqaliswa kwekhodi yokubhalisa ukuhlonza ngempumelelo imishini yezokwelapha ethengiswayo futhi esetshenziswa emakethe yase-US, kungakhathaliseki ukuthi ikhiqizwa kuphi. . Uma isiqalisiwe, amalebula e-NHRIC kanye ne-NDC azoqedwa, futhi zonke izisetshenziswa zezokwelapha kudingeka zisebenzise le khodi entsha yokubhalisa njengophawu emaphaketheni angaphandle omkhiqizo. Ngaphezu kokubonakala, i-UDI kufanele yenelise kokubili umbhalo ongenalutho kanye nokuhlonza okuzenzakalelayo kanye nokuthwebula idatha (AIDC). Umuntu ophethe ukulebula idivayisi kufanele futhi athumele ulwazi oluqondile lomkhiqizo ngamunye "e-FDA International Specialty Medical Center". Isizindalwazi sokuhlonza idivayisi i-UDID” sivumela umphakathi ukuthi ubuze futhi ulande idatha efanele (okuhlanganisa ulwazi olusuka ekukhiqizweni, ukusatshalaliswa kuya ekusetshenzisweni kwamakhasimende, njll.) ngokufinyelela kusizindalwazi, kodwa isizindalwazi ngeke sinikeze ulwazi lomsebenzisi wedivayisi. 

Ikakhulukazi ikhodi ehlanganisa izinombolo noma izinhlamvu. Iqukethe ikhodi yokuhlonza idivayisi (DI) kanye nekhodi yokuhlonza yokukhiqiza (PI).

Ikhodi yesibonakaliso yedivayisi iyikhodi engaguquki eyisibopho, ehlanganisa ulwazi lwabasebenzi abaphethe ilebula, inguqulo ethile noma imodeli yedivayisi, kuyilapho ikhodi yokuhlonza umkhiqizo ingacaciswanga ngokukhethekile, futhi ihlanganisa inombolo yenqwaba yokukhiqiza idivayisi, inombolo yomkhiqizo, idethi yokukhiqiza, idethi yokuphelelwa yisikhathi nokuphathwa njengedivayisi. Ikhodi yokuhlonza eyingqayizivele yomkhiqizo wezicubu zamangqamuzana aphilayo.

Okulandelayo, ake sikhulume nge-GUDID, I-Global Unique Device Identification System (GUDID), I-FDA International Special Medical Device Identification Library. Isizindalwazi senziwa esidlangalaleni ngohlelo lwemibuzo lwe-AccessGUDID. Awukwazi ukufaka ngokuqondile ikhodi ye-DI ye-UDI olwazini lwelebula ekhasini lewebhu lesizindalwazi ukuze uthole ulwazi lomkhiqizo, kodwa ungasesha futhi izici zanoma iyiphi idivayisi yezokwelapha (njengesihlonzi sedivayisi, inkampani noma igama lohwebo, igama elijwayelekile, noma imodeli nenguqulo yedivayisi). ), kodwa kubalulekile ukuqaphela ukuthi le database ayinikezi amakhodi we-PI wamadivayisi.

Okusho ukuthi, incazelo ye-UDI: I-Unique Device Identification (UDI) iwumazisi onikezwa idivayisi yezokwelapha phakathi nomjikelezo wayo wokuphila, futhi iwukuphela "komazisi" ochungechungeni lokuhlinzekwa kwemikhiqizo. Ukwamukelwa emhlabeni wonke kwe-UDI ebumbene futhi evamile kunenzuzo ukuthuthukisa ukucaca kwe-supply chain nokusebenza kahle; kunenzuzo ukunciphisa izindleko zokusebenza; kuyasiza ukubona ukwabelana nokushintshisana ngolwazi; kunenzuzo ukuqapha izehlakalo ezimbi nokukhumbula imikhiqizo enesici, ukuthuthukisa ikhwalithi yezinsizakalo zezokwelapha, nokuvikela ukuphepha kweziguli.