Ngo-20 13, i-Food and Drug Administration (FDA) yakhipha umthetho wokugcina osungula isistimu yokuhlonza idivayisi eyingqayizivele eklanyelwe ukuhlonza idivayisi ngokwanele ngokusabalalisa nokusebenzisa. Umthetho wokugcina udinga izilebula zedivayisi ukuthi zifake isihlonzi sedivayisi esiyingqayizivele (i-UDI) kumalebula wedivayisi namaphakheji, ngaphandle kwalapho umthetho uhlinzeka ngokuhlukile noma okunye. I-UDI ngayinye kufanele ihlinzekwe ngenguqulo yombhalo ongacacile nangefomu esebenzisa ubuchwepheshe bokuhlonza nokuthwebula idatha (AIDC) okuzenzakalelayo. I-UDI kuyodingeka futhi ukuthi imakwe ngokuqondile ocingweni olwenzelwe ukusetshenziswa okungaphezu kokukodwa, futhi okuhloswe ukuthi lucutshungulwe kabusha ngaphambi kokusetshenziswa ngakunye. Izinsuku ezikumalebula wedivayisi namaphakheji azokwethulwa ngefomethi evamile ehambisana nezindinganiso zamazwe ngamazwe kanye nokwenza ngamazwe ngamazwe.
I-UDI iyikhodi eyingqayizivele yezinombolo noma yamagama nezinombolo equkethe izingxenye ezimbili:
isihlonzi sedivayisi (DI), okuyisibopho, ingxenye engashintshi ye-UDI ekhomba ilebula nenguqulo ethile noma imodeli yedivayisi, futhi
isihlonzi sokukhiqiza (PI), ingxenye enemibandela, eguquguqukayo ye-UDI ekhomba okukodwa noma ngaphezulu kokulandelayo uma kufakwe kulebula yedivayisi:
inombolo yenkatho noma yenqwaba lapho umshini owenziwe khona;
inombolo ye-serial yedivayisi ethile;
usuku lokuphelelwa yisikhathi kwedivayisi ethile;
usuku okwakhiqizwa ngalo idivayisi ethile;
ikhodi yokuhlonza ehlukile edingwa yi-§1271.290(c) yeseli yomuntu, ithishu, noma iselula kanye nomkhiqizo osuselwe kumathishu (HCT/P) olawulwa njengedivayisi.
Wonke ama-UDI azokhishwa ngaphansi kwesistimu esetshenziswa yi-ejensi ekhiphayo egunyazwe yi-FDA. Umthetho uhlinzeka ngenqubo umfakisicelo azofuna ngayo ukugunyazwa kwe-FDA, ucacisa ulwazi umfakisicelo okufanele alunikeze i-FDA, kanye nemibandela ezosetshenziswa i-FDA ekuhloleni izicelo.
Okunye okuhlukile nokunye kuchazwe emthethweni wokugcina, oqinisekisa ukuthi izindleko nemithwalo igcinwa isezingeni eliphansi. Uhlelo lwe-UDI luzoqala ukusebenza ngezigaba, esikhathini esiyiminyaka eyisikhombisa, ukuze kuqinisekiswe ukuqaliswa okushelelayo kanye nokusabalalisa izindleko nemithwalo yemisebenzi ngokuhamba kwesikhathi, kunokuba kuthathwe konke ngesikhathi esisodwa.
Njengengxenye yesistimu, amalebula wedivayisi kudingeka ukuthi athumele ulwazi ku-Global Unique Device Identification Database (GUDID) elawulwa yi-FDA. I-GUDID izobandakanya isethi evamile yezinto eziyisisekelo zokuhlonza idivayisi ngayinye ene-UDI, futhi iqukethe KUPHELA i-DI, engasebenza njengokhiye wokuthola ulwazi lwedivayisi kusizindalwazi. Ama-PI awayona ingxenye ye-GUDID.
I-FDA yenza ingxenye enkulu yalolu lwazi itholakale emphakathini kwa-AccessGUDID, ngokubambisana ne-National Library of Medicine. Abasebenzisi bemishini yezokwelapha bangasebenzisa i-AccessGUDID ukuze baseshe noma balande ulwazi olumayelana namadivayisi. I-UDI ayibonisi, futhi imininingwane egciniwe ye-GUDID ngeke iqukathe, noma yiluphi ulwazi mayelana nokuthi ubani osebenzisa idivayisi, okuhlanganisa nemininingwane yobumfihlo yomuntu siqu.
Ukuze uthole ulwazi olwengeziwe nge-GUDID ne-UDI sicela ubheke ikhasi Lezinsiza ze-UDI lapho uzothola khona izixhumanisi zamamojula wemfundo awusizo, izinkombandlela, nezinye izinto eziphathelene ne-UDI.
'Ilebula' yinoma yimuphi umuntu obangela ukuthi ilebula isetshenziswe kudivayisi, noma obangela ukuthi ilebula yedivayisi ilungiswe, ngenhloso yokuthi idivayisi izosatshalaliswa ngokwentengiso ngaphandle kokushintshwa noma ukuguqulwa kwelebula. Ukwengezwa kwegama, nolwazi lokuxhumana lomuntu osabalalisa idivayisi, ngaphandle kokwenza noma yiziphi izinguquko kulebula akukona ukuguqulwa ngezinjongo zokunquma ukuthi umuntu uyilebula yini. Ezimweni eziningi, ilebula ingaba umkhiqizi wedivayisi, kodwa ilebula ingaba umthuthukisi wezinto ezibekiwe, iprosesa yedivayisi esetshenziswa kanye, isihlanganisi sekhithi esilula, isipakisha kabusha, noma isilahlisi kabusha.
I-Automatic identification and data capture (AIDC) isho noma yibuphi ubuchwepheshe obudlulisa i-UDI noma isihlonzi sedivayisi yocingo ngendlela engafakwa kwirekhodi lesiguli elisebenza ngogesi noma olunye uhlelo lwekhompuyutha ngenqubo ezenzakalelayo.
