Muna 20 13, iyo Chikafu neDrug Administration (FDA) yakaburitsa mutemo wekupedzisira unomisikidza yakasarudzika mudziyo wekuzivisa sisitimu yakagadzirirwa kunyatsoona michina kuburikidza nekugovera nekushandisa. Mutemo wekupedzisira unoda kuti vanyori vemudziyo vabatanidze chiziviso chemudziyo wakasiyana (UDI) pamalebhi emudziyo uye mapakeji, kunze kwekunge mutemo unopa kusarudzika kana imwe nzira. Imwe neimwe UDI inofanirwa kupihwa mune yakajeka-mavara vhezheni uye mune fomu inoshandisa otomatiki chiziviso uye data capture (AIDC) tekinoroji. Iyo UDI inozodikanwawo kuti imakwe zvakananga pamudziyo wakagadzirirwa kushandiswa kanopfuura kamwechete, uye unotarisirwa kudzokororwa usati washandiswa. Mazuva ari pamatairi emidziyo uye mapakeji anofanirwa kuratidzwa mune yakajairwa fomati inofambirana nezviyero zvepasi rose uye tsika dzepasirese.
A UDI yakasarudzika nhamba kana alphanumeric kodhi ine zvikamu zviviri:
chiziviso chemudziyo (DI), chinosungirwa, chakagadziriswa chikamu cheUDI chinozivisa mucherechedzi uye neshanduro chaiyo kana modhi yechishandiso, uye
chiziviso chekugadzira (PI), chinomisikidzwa, chinoshanduka chikamu cheUDI chinotaridza chimwe kana kupfuura chezvinotevera kana chaiswa pazita remudziyo:
mujenya kana nhamba yebatch mukati umo mudziyo wakagadzirwa;
nhamba ye serial yechimwe chigadzirwa;
zuva rekupera kwechimwe chigadzirwa;
zuva rakagadzirwa mudziyo chaiwo;
iyo yakasarudzika yekuzivikanwa kodhi inodiwa ne §1271.290 (c) yesero remunhu, tishu, kana cellular uye tishu-based chigadzirwa (HCT / P) inodzorwa semudziyo.
Ese maUDI anofanirwa kupihwa pasi pechirongwa chinoshanda neFDA-yakatenderwa yekuburitsa agency. Mutemo unopa maitiro ayo munhu anenge akumbira angatsvaga mvumo yeFDA, anotsanangura ruzivo runofanira kupa kune FDA, uye maitiro eFDA anozoshanda mukuongorora zvikumbiro.
Zvimwe zvisiri izvo uye dzimwe nzira dzakatsanangurwa mumutemo wekupedzisira, kuve nechokwadi chekuti mutengo uye mitoro inochengetwa iri shoma. Iyo UDI sisitimu ichatanga kushanda mumatanho, mukati menguva yemakore manomwe, kuve nechokwadi chekushandiswa kwakanaka uye kuparadzira mutengo uye mitoro yekuitisa nekufamba kwenguva, pane kubatwa zvese kamwechete.
Sechikamu chegadziriro, vanyoreri vemidziyo vanosungirwa kuendesa ruzivo kuFDA-inotungamirwa neGlobal Unique Device Identification Database (GUDID). Iyo GUDID ichasanganisira yakajairwa seti yezvakakosha zvinongedza zvinhu zvemudziyo wega wega une UDI, uye ine CHETE DI, iyo yaizoshanda sekiyi yekuwana ruzivo rwemudziyo mudhatabhesi. MaPIs haasi chikamu cheGUDID.
FDA iri kuita kuti ruzivo urwu ruwanikwe kune veruzhinji paAccessGUDID, kuburikidza nekudyidzana neNational Library of Medicine. Vashandisi vemidziyo yekurapa vanogona kushandisa AccessGUDID kutsvaga kana kudhawunirodha ruzivo nezvemidziyo. Iyo UDI hairatidze, uye iyo GUDID dhatabhesi haizove neruzivo rwekuti ndiani anoshandisa mudziyo, kusanganisira ruzivo rwekuvanzika.
Kuti uwane rumwe ruzivo nezve GUDID neUDI ndapota ona iyo UDI Zviwanikwa peji kwaunowana zvinongedzo kune zvinobatsira dzidzo modules, nhungamiro, uye zvimwe zvinhu zvine chekuita neUDI.
A 'labeler' munhu chero upi zvake anokonzera kuti zita rishandiswe pamudziyo, kana kuti anoita kuti zita remudziyo rigadziriswe, nechinangwa chekuti mudziyo wacho ugotengeswa pasina chinotsiviwa kana kuvandudzwa kwechigadzirwa chacho. Kuwedzerwa kwezita re, uye ruzivo rwekusangana rwe, munhu anogovera mudziyo, pasina kuita chero imwe shanduko kune iyo label haisi shanduko yezvinangwa zvekuona kana munhu ari mucherechedzi. Muzviitiko zvakawanda, mucherechedzi angave ari mugadziri wemidziyo, asi anonyora anogona kunge ari mugadziri wezvimiro, anongoshandisa kamwe-kamwe mudziyo reprocessor, nyore kit assembler, repackager, kana relabeler.
Automatic identification and data capture (AIDC) zvinoreva chero tekinoroji inoburitsa UDI kana chiziviso chemudziyo uri muchimiro chinogona kuiswa murekodha yemagetsi yemurwere kana imwe hurongwa hwekombuta kuburikidza neautomated process.
