Kwi -2013, i-Food and Drug Administration (FDA) ikhuphe umgaqo wokugqibela wokumisela inkqubo yokuchonga isixhobo esisodwa esenzelwe ukuchonga izixhobo ngokufanelekileyo ngokusasazwa kunye nokusetyenziswa.Umgaqo wokugqibela ufuna iilebhula zesixhobo zibandakanye isichongi sesixhobo esisodwa (UDI) kwiileyibhile zesixhobo kunye neepakethe, ngaphandle kwalapho umthetho ubonelela ngokuhlukileyo okanye enye indlela.I-UDI nganye kufuneka ibonelelwe nge-plain-text version kunye nefom esebenzisa iteknoloji yokuchonga kunye nokufakwa kwedatha (AIDC) ngokuzenzekelayo.I-UDI kuya kufuneka kwakhona ukuba imakishwe ngokuthe ngqo kwisixhobo esilungiselelwe ukusetyenziswa ngaphezu kwesinye, kwaye enjongo yaso iphinde iprocessed phambi kokusetyenziswa ngakunye.Imihla kwiilebhile zesixhobo kunye neepakethe kufuneka ziboniswe ngendlela esemgangathweni ehambelana nemigangatho yamazwe ngamazwe kunye nezenzo zamazwe ngamazwe.
I-UDI yikhowudi yamanani ekhethekileyo okanye ikhowudi yealphanumeric enamacandelo amabini:
- isazisi sesixhobo (DI), isinyanzelo, inxalenye esisigxina ye-UDI echonga umbhali kunye noguqulelo oluthile okanye imodeli yesixhobo, kunye
- isazisi semveliso (PI), icandelo elinemiqathango, eliguquguqukayo le-UDI elichonga enye okanye ngaphezulu kwezi zilandelayo xa zibandakanyiwe kwileyibhile yesixhobo:
- iqashiso okanye inombolo yebhetshi apho isixhobo senziwayo;
- inombolo yesiriyali yesixhobo esithile;
- umhla wokuphelelwa kwesixhobo esithile;
- umhla wokwenziwa kwesixhobo esithile;
- ikhowudi yokuchonga eyahlukileyo efunwa yi-§1271.290 (c) kwiseli yomntu, izicubu, okanye i-cell kunye ne-tissue-based product (HCT / P) elawulwa njengesixhobo.
Zonke ii-UDI kufuneka zikhutshwe phantsi kwenkqubo esetyenziswa yi-arhente ekhuphayo evunyiweyo yi-FDA.Umgaqo ubonelela ngenkqubo apho umenzi-sicelo afuna ukuvunywa kwe-FDA, ichaza ulwazi umfaki-sicelo kufuneka alunike i-FDA, kwaye imilinganiselo ye-FDA iya kusebenza ekuphononongeni izicelo.
Ezinye izinto ezingaqhelekanga kunye neendlela ezizezinye zichazwe kumgaqo wokugqibela, ukuqinisekisa ukuba iindleko kunye nemithwalo igcinwa iphantsi.Inkqubo ye-UDI iya kuqalisa ukusebenza ngokwamanqanaba, kwithuba leminyaka esixhenxe, ukuqinisekisa ukuphunyezwa okugudileyo kunye nokusabalalisa iindleko kunye nomthwalo wokuphunyezwa ekuhambeni kwexesha, kunokuba ifunnwe yonke ngexesha elinye.
Njengenxalenye yenkqubo, iilebhile zesixhobo kufuneka zingenise ulwazi kwi-FDA elawulwa yi-Global Unique Device Identification Database (GUDID).I-GUDID iya kubandakanya iseti esemgangathweni yezinto ezisisiseko zokuchonga kwisixhobo ngasinye esine-UDI, kwaye siqulathe KUPHELA i-DI, eya kusebenza njengesitshixo sokufumana ulwazi lwesixhobo kuvimba weenkcukacha.Ii-PIs aziyonxalenye ye-GUDID.
I-FDA yenza uninzi lwalo lwazi lufumaneke kuluntu kwi-AccessGUDID, ngokusebenzisana neThala leeNcwadi leSizwe leMithi.Abasebenzisi bezixhobo zonyango banokusebenzisa i-AccessGUDID ukukhangela okanye ukukhuphela ulwazi malunga nezixhobo.I-UDI ayibonisi, kwaye i-database ye-GUDID ayiyi kuqulatha, naluphi na ulwazi malunga nokuba ngubani osebenzisa isixhobo, kubandakanywa nolwazi lwangasese lomntu.
Ngolwazi oluthe vetshe nge-GUDID kunye ne-UDI nceda ubone i-UDI Resources page apho uya kufumana amakhonkco kwiimodyuli zemfundo eziluncedo, izikhokelo, kunye nezinye imathiriyeli ezinxulumene ne-UDI.
'Ilebheli' nguye nawuphi na umntu obangela ukuba ileyibhile ifakwe kwisixhobo, okanye obangela ukuba ileyibhile yesixhobo iguqulwe, ngenjongo yokuba isixhobo siya kusasazwa ngorhwebo ngaphandle kokutshintshwa okanye ukuguqulwa kwesixhobo esilandelayo. ileyibhile.Ukongezwa kwegama, kunye neenkcukacha zoqhagamshelwano zomntu ohambisa isixhobo, ngaphandle kokwenza naluphi na olunye utshintsho kwileyibhile alukho uhlengahlengiso ngeenjongo zokumisela ukuba umntu ungumlebhisi.Kwiimeko ezininzi, umleyibheli uya kuba ngumenzi wesixhobo, kodwa umleyibheli inokuba ngumphuhlisi wolubalo, umsetyenzana wesixhobo esisetyenziswa kanye, isihlanganisi sekhithi eluncedo, isipakishi, okanye isiphinda-phinda.
Ukuchongwa ngokuzenzekela kunye nokuthathwa kwedatha (AIDC) kuthetha nabuphi na ubuchwephesha obuhambisa i-UDI okanye isixhobo sokuchonga isixhobo ngendlela enokufakwa kwirekhodi yesigulana esebenza ngombane okanye enye inkqubo yekhompyutha kusetyenziswa inkqubo yomatshini.
