Le ƒe 20 13 me la, Nuɖuɖu Kple Atike Ŋuti Dɔwɔƒe (FDA) ɖe se mamlɛtɔ aɖe ɖe go si ɖo mɔ̃ɖaŋununya ƒe dzesidenu tɔxɛ aɖe si wowɔ be woatsɔ ade dzesi mɔ̃wo nyuie to wo mama kple wo zazã me. Se mamlɛtɔa bia tso mɔ̃a ƒe ŋkɔwo dzi be woatsɔ mɔ̃ ƒe dzesidenu tɔxɛ aɖe (UDI) ade mɔ̃a ƒe ŋkɔwo kple agbalẽviwo dzi, negbe afisiwo sea na woɖe mɔ ɖe eŋu alo mɔnu bubu aɖe ko. Ele be woatsɔ UDI ɖesiaɖe ana le nuŋɔŋlɔ gbadzaa ƒe tɔtrɔ me eye woatsɔe ana le nɔnɔme si me wozãa mɔ̃ɖaŋununya si wotsɔna dea dzesi ame ɖokui le eɖokui si kple esi le wo si (AIDC) me. Woabia tso UDI la hã si be woade dzesi mɔ̃ aɖe si woɖo be woazã wu zi ɖeka, eye woɖoe be woagbugbɔ atrɔ asi le eŋu hafi woazãe ɖesiaɖe. Ele be woatsɔ ŋkeke siwo dzi woŋlɔ mɔ̃wo ƒe ŋkɔwo kple agbalẽviwo ɖo la afia le ɖoɖo si sɔ nu si sɔ kple dukɔwo dome dzidzenuwo kple dukɔwo dome nuwɔnawo.
UDI nye xexlẽdzesi alo ŋɔŋlɔdzesi tɔxɛ aɖe si me akpa eve le:
mɔ̃ aɖe ƒe dzesidenu (DI), si nye UDI ƒe akpa aɖe si wòle be wòanye, si woɖo ɖi si dea dzesi mɔ̃ aɖe ƒe dzesidenu kple eƒe nɔnɔme tɔxɛ alo eƒe nɔnɔme, kple .
A wɔwɔ ƒe dzesidenu (PI), nɔnɔme, tɔtrɔ ƒe akpa si le UDI si dea dzesi nusiwo gbɔna dometɔ ɖeka alo esi wu nenema ne wotsɔe de mɔ̃ aɖe ƒe ŋkɔ dzi:
lot alo batch xexlẽdzesi si me wowɔ mɔ̃ aɖe le;
mɔ̃ aɖe koŋ ƒe xexlẽdzesi si woɖo ɖe wo nɔewo yome;
ŋkeke si dzi mɔ̃ aɖe koŋ ƒe ɣeyiɣia wu enu;
Ɣletiŋkeke si dzi wowɔ mɔ̃ aɖe koŋ;
Dzesidede agbalẽ si to vovo si §1271.290(c) bia na amegbetɔ ƒe lãmenugbagbevi, lãkusi, alo lãmenugbagbevi kple lãkusi (HCT/P) si ŋu wowɔ ɖoɖo ɖo abe mɔ̃ ene.
Ele be woaɖe UDIwo katã ɖe go le ɖoɖo aɖe si dɔwɔƒe si dzi FDA da asi ɖo si FDA da asi ɖe edzi le la te. Sea na ɖoɖo aɖe si dzi ame si le biabiam la adi be yeadi FDA ƒe mɔɖeɖe le, gblɔ nyatakaka siwo wòle be ame si le biabiam la na FDA, kple dzidzenu siwo FDA awɔ le dɔbiagbalẽviwo me dzodzro me.
Wogblɔ nusiwo to vovo kple esiwo woate ŋu azã ɖe wo teƒe aɖewo le se mamlɛtɔa me, si ana woakpɔ egbɔ be woɖe gazazãwo kple agbawo dzi kpɔtɔ vie. UDI ɖoɖoa adze dɔwɔwɔ gɔme le ɣeyiɣiwo me, le ƒe adre ƒe ɣeyiɣi aɖe me, be woakpɔ egbɔ be wowɔ dɔ nyuie eye woakaka gazazãwo kple agba siwo le edziwɔwɔ me le ɣeyiɣi aɖe megbe, tsɔ wu be woaxɔe zi ɖeka.
Abe ɖoɖoa ƒe akpa aɖe ene la, wobia tso mɔ̃awo ƒe ŋkɔwo ŋɔŋlɔ si be woatsɔ nyatakakawo ayi na FDA-dɔwɔƒea ƒe xexeame katã ƒe mɔ̃ɖaŋununya ƒe nyatakakadzraɖoƒe si nye Unique Devident Database (GUDID). GUDID la anye gɔmedzenu siwo woatsɔ ade dzesi nu ƒe hatsotso si sɔ na mɔ̃ ɖesiaɖe si si UDI le, eye DI koe anɔ eme, si anye nu vevitɔ si ana woaxɔ mɔ̃a ŋuti nyatakakawo le nyatakakadzraɖoƒea. PIwo menye Gudid la ƒe akpa aɖeke o.
FDA le nyatakaka siawo ƒe akpa gãtɔ wɔm na dukɔa le AccessGudid, to hadomeɖoɖo kple Dukɔa ƒe Atikewɔwɔ ƒe Agbalẽdzraɖoƒe dzi. Atikewɔnuwo zãlawo ate ŋu azã AccessGudid atsɔ adi nyatakakawo tso mɔ̃wo ŋu alo awɔ woƒe kɔpi. UDI la mefia o, eye GUDID ƒe nyatakakadzraɖoƒea hã manɔ eme o, nyatakaka aɖeke si ku ɖe amesi zãa mɔ̃ aɖe, si me Ame ŋutɔ ƒe Nyatakakawo Ŋuti Nyatakakawo hã le, ŋu.
Ne èdi nyatakaka bubuwo tso GUDID kple UDI ŋu la, taflatse kpɔ UDI Resources ƒe axa si dzi nàkpɔ kadodo siwo yi hehenana modules siwo akpe ɖe ame ŋu, mɔfiamewo, kple UDI-nu bubu siwo do ƒome kple wo nɔewo ŋu le.
'lala' nye ame sia ame si nana wotsɔa dzesideŋkɔ aɖe dea mɔ̃ aɖe dzi, alo si nana wotrɔa asi le mɔ̃ aɖe ƒe ŋkɔ ŋu, kple susu be woama mɔ̃a le asitsatsa me evɔ womaɖɔli dzesideŋkɔa alo atrɔ asi le eŋu emegbe o. Ame si ma mɔ̃a ƒe ŋkɔ, kple kadodo ŋuti nyatakakawo tsɔtsɔ kpe ɖe eŋu, evɔ tɔtrɔ bubu aɖeke mawɔ ɖe dzesidenua dzi o la menye tɔtrɔ le eŋu be woanya nenye be amee nye dzesidenu o. Le go geɖe me la, nusi wotsɔ ŋlɔa nu ɖe nu ŋue nye mɔ̃a wɔla, gake nusi wotsɔ ŋlɔa nu ɖe eŋu ate ŋu anye nɔnɔmetatawɔla, mɔ̃ si wozãna zi ɖeka, si nye nusi wotsɔna ƒoa nu ɖe nu ŋu, nu yeye si woatsɔ ablae, alo agbalẽ si woatsɔ agbugbɔ ŋkɔ na.
Dzesidede ame ɖokui kple nyatakakawo xɔxɔ le wo ɖokui si (AIDC) fia mɔ̃ɖaŋununya ɖesiaɖe si atsɔ UDI alo mɔ̃ aɖe ƒe dzesidenu si nye mɔ̃ aɖe le nɔnɔme si woate ŋu ade elektrɔnik dɔnɔwo ƒe nuŋlɔɖi alo kɔmpiuta bubu me to mɔnu si wowɔna le wo ɖokui si me.
