Kwi-20 13, i-Food and Drug Administration (FDA) ikhiphe umthetho wokugcina osungula uhlelo oluhlukile lokuhlonza idivaysi eyenzelwe ukukhomba amadivayisi afanele ngokusatshalaliswa nokusetshenziswa. Umthetho wokugcina udinga i-Fager yedivayisi ukufaka isikhombi sedivayisi esiyingqayizivele (UDI) kumalebula wedivayisi namaphakeji, ngaphandle kwalapho umthetho uhlinzekela khona okuhlukile noma okunye. I-UDI ngayinye kufanele inikezwe enguqulweni ye-Plain-Ethektri futhi ngefomu elisebenzisa ukukhonjwa okuzenzakalelayo kanye ne-AIDC) Technology. I-UDI izodingeka futhi ifakwe uphawu ngqo kudivayisi eyenzelwe ukusetshenziswa okungaphezu kokukodwa, futhi ihlose ukuvuswa ngaphambi kokusetshenziswa ngakunye. Izinsuku kumalebula wedivayisi namaphakeji kufanele avezwe ngefomethi ejwayelekile evumelana namazinga omhlaba kanye nemikhuba yamazwe aphesheya.
I-UDI iyikhodi ehlukile yezinombolo noma ye-alphanumeric equkethe izingxenye ezimbili:
Isikhombi Sedivayisi (i-DI), Ingxenye ephoqelekile, ebekiwe ye-UDI ekhomba i-Funger nenguqulo ethile noma imodeli yedivayisi, futhi
Isikhombi Sokukhiqiza (PI), ingxenye enemibandela, eguquguqukayo ye-UDI ekhomba okukodwa noma ngaphezulu kokulandelayo lapho kufakwa kwilebula yedivayisi:
Inombolo ye-Lot noma i-Batch lapho kukhiqizwa khona idivaysi;
inombolo ye-serial yedivayisi ethile;
usuku lokuphelelwa yisikhathi sedivayisi ethile;
Usuku lwedivayisi ethile lwenziwa khona;
Ikhodi ekhomba ehlukile edingwa yi-§1271.290 (c) yesitokisi somuntu, izicubu, noma umkhiqizo osuselwa kwisicubu kanye nezicubu (i-HCT / P) ezilawulwa njengedivayisi.
Onke ama-UDI azokhishwa ngaphansi kohlelo olwenziwa yi-A ejensi ekhipha i-FDA-accredited ekhishwa. Umthetho uhlinzeka ngenqubo lapho umenzi wesicelo angafuna khona ukuqinisekiswa kwe-FDA, acacise imininingwane yokuthi umfakisicelo kufanele ahlinzeke ku-FDA, kanti nenqubo ye-FDA izosebenza ekuhlolweni kwezicelo.
Okuhlukile nezinye izindlela zichazwe kumthetho wokugcina, ukuqinisekisa ukuthi izindleko nemithwalo zigcinwa zincane. Uhlelo lwe-UDI luzosebenza ezigabeni, esikhathini esiyiminyaka eyisikhombisa, ukuqinisekisa ukuqaliswa okubushelelezi futhi ukusabalalisa izindleko kanye nemithwalo yokuqalisa ngokuhamba kwesikhathi.
Njengengxenye yohlelo, ababhalishi bedivaysi kudingeka balethe imininingwane kwi-FDA-ephethwe yi-PAHTION PAHLUKO Ehlukile Yedivayisi Yedivayisi (Gudid). I-Gudid izofaka iqoqo elijwayelekile lezinto eziyisisekelo zokuhlonza kudivayisi ngayinye nge-UDI, futhi liqukethe kuphela i-DI, elizosebenza njengesihluthulelo sokuthola imininingwane yedivayisi ku-database. Ama-PI akayona ingxenye ye-gudid.
I-FDA yenza okuningi kwalolu lwazi kutholakale emphakathini e-accessGudid, ngokubambisana ne-National Library of Medicine. Abasebenzisi bamadivaysi ezokwelapha bangasebenzisa i-accessivegudid ukusesha noma ukulanda imininingwane ngamadivayisi. I-UDI ayikhombisi, futhi i-GUDID database ngeke iqukethe, noma yiluphi ulwazi mayelana nokuthi ngubani osebenzisa idivaysi, kufaka phakathi imininingwane yobumfihlo yomuntu siqu.
Ukuthola imininingwane engaphezulu nge-gudid ne-UDI sicela ubone ikhasi lezinto ze-UDI lapho uzothola khona izixhumanisi zamamojula wezemfundo asiza, imiyalo, nezinye izinto ezihlobene ne-UDI.
I-a 'elengiler ' yinoma yimuphi umuntu obangela ilebula ukuthi asetshenziswe kwidivaysi, noma ebibale ilebula ledivaysi ukuthi iguqulwe, ngenhloso yokuthi idivaysi izohanjiswa ngokunemba ngaphandle kokunye okulandelayo noma ukuguqulwa kwelebula. Ukungezwa kwegama, kanye nolwazi lokuxhumana, umuntu osabalalisa idivaysi, ngaphandle kokwenza ezinye izinguquko kwilebula akulona ukuguqulwa kwezinhloso zokunquma ukuthi umuntu ungumbhali. Ezimweni eziningi, i-ilebula izoba ngumenzi wedivayisi, kepha i-ilebula ingaba ngunjiniyela ocacisiwe, ukuphindisela okukodwa okuphindwayo, isici esilula sekhithi, i-repAckager, noma i-relabeler.
Ukukhonjwa okuzenzakalelayo kanye nokuthwebula idatha (i-AIDC) kusho noma ibuphi ubuchwepheshe obudlulisela i-UDI noma isikhombi sedivayisi sedivayisi esefomini elingafakwa kwirekhodi lesiguli se-elekhthronikhi noma enye inqubo yekhompyutha ngenqubo ezenzakalelayo.
