Iindaba

Isazisi sesixhobo esisodwa (i-UDI) "yinkqubo yokuchonga isixhobo sonyango esikhethekileyo" esekwe yi-US Food and Drug Administration. Ukuphunyezwa kwekhowudi yokubhalisa kukuchonga ngokufanelekileyo izixhobo zonyango ezithengiswayo kwaye zisetyenziswe kwiimarike zase-US, kungakhathaliseki ukuba ziveliswa phi. . Xa sele iphunyeziwe, iilebhile ze-NHRIC kunye ne-NDC ziya kubhangiswa, kwaye zonke izixhobo zonyango kufuneka zisebenzise le khowudi entsha yokubhalisa njengelogo kwipakethe yangaphandle yemveliso. Ukongeza kokubonakala, i-UDI kufuneka yanelise zombini isicatshulwa esicacileyo kunye nokuchongwa ngokuzenzekelayo kunye nokufakwa kwedatha (AIDC). Umntu ophetheyo ekuleyibhelini isixhobo kufuneka kwakhona athumele ulwazi oluchanekileyo ngemveliso nganye kwi-"FDA International Specialty Medical Centre". I-database ye-IDID yokuchongwa kwesixhobo ivumela uluntu ukuba lubuze kwaye lukhuphe idatha efanelekileyo (kubandakanywa nolwazi oluvela kwimveliso, ukuhanjiswa kusetyenziso lwabathengi, njl.) ngokufikelela kwisiseko sedatha, kodwa i-database ayiyi kubonelela ngolwazi lomsebenzisi wesixhobo. 

Ikakhulu ikhowudi enamanani okanye iileta. Iqulethe ikhowudi yokuchonga isixhobo (DI) kunye nekhowudi yokuchonga imveliso (PI).

Ikhowudi yokuchonga isixhobo yikhowudi emiselweyo enyanzelekileyo, ebandakanya ulwazi lwabasebenzi bolawulo lweleyibhile, inguqulelo ethile okanye imodeli yesixhobo, ngelixa ikhowudi yokuchonga imveliso ayichazwanga ngokukodwa, kwaye ibandakanya inombolo yebhetshi yokuvelisa isixhobo, inombolo yothotho, umhla wemveliso, umhla wokuphelelwa kunye nolawulo njengesixhobo. Ikhowudi yokuchonga eyodwa yemveliso yeseli yeseli ephilayo.

Okulandelayo, makhe sithethe nge-GUDID, i-Global Eyodwa yeSixhobo sokuchongwa kweSixhobo (GUDID), iThala leeNcwadi le-FDA eliKhethekileyo leSixhobo soNyango seHlabathi. Uvimba weenkcukacha wenziwa esidlangalaleni kusetyenziswa inkqubo yombuzo ye-AccessGUDID. Ayinako kuphela ukungena ngqo ikhowudi DI ye-UDI kulwazi ileyibhile kwiphepha lewebhu lesiseko sokufumana ulwazi lwemveliso, kodwa unokukhangela iimpawu zaso nasiphi na isixhobo sonyango (esifana nesazisi isixhobo, inkampani okanye igama lorhwebo, igama legeneric, okanye imodeli noguqulelo lwesixhobo). ), kodwa kuyafaneleka ukuba uqaphele ukuba le database ayiboneleli ngeekhowudi zePI zezixhobo.

Oko kukuthi, inkcazo ye-UDI: I-Unique Device Identification (UDI) luphawu olunikwe isixhobo sonyango kumjikelezo wobomi bayo bonke, kwaye kuphela "ikhadi lesazisi" kwikhonkco lokubonelela ngemveliso. Ukwamkelwa kwehlabathi jikelele kwe-UDI edibeneyo kunye nesemgangathweni kunenzuzo ekuphuculeni ukucaca kwekhonkco lokubonelela kunye nokusebenza kakuhle; kunenzuzo ukunciphisa iindleko zokusebenza; kuluncedo ukuqaphela ukwabelana ngolwazi kunye notshintshiselwano; kunenzuzo ekubekeni iliso kwiziganeko ezimbi kunye nokukhumbula iimveliso ezineziphene, ukuphucula umgangatho weenkonzo zonyango, kunye nokukhusela ukhuseleko lwezigulane.