Muna 2013, iyo Chikafu neDrug Administration (FDA) yakaburitsa mutemo wekupedzisira unomisikidza yakasarudzika mudziyo wekuzivikanwa 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-zvinyorwa vhezheni uye mune fomu inoshandisa otomatiki chiziviso uye data capture (AIDC) tekinoroji.Iyo UDI inozodikanwawo kuti inyatso kumakwa pamudziyo wakagadzirirwa kushandiswa kanopfuura kamwechete, uye unotarisirwa kudzokororwa usati washandiswa.Mazuva ari pamatairi emidziyo uye mapakeji anofanirwa kuiswa muchimiro chakajairwa chinopindirana nezviyero zvepasi rose nemaitiro epasi rese.
A UDI yakasarudzika nhamba kana alphanumeric kodhi ine zvikamu zviviri:
- chiziviso chemudziyo (DI), chinosungirwa, chakagadziriswa chikamu cheUDI chinozivisa mucherechedzi uye iyo chaiyo vhezheni kana modhi yemudziyo, uye
- chiziviso chekugadzira (PI), chinomisikidzwa, chinoshanduka chikamu cheUDI chinotaridza chimwe kana zvimwe zvezvinotevera kana zvasanganisirwa pazita remudziyo:
- mujenya kana nhamba yebatch mukati mawo chigadzirwa chakagadzirwa;
- nhamba ye serial yechimwe chigadzirwa;
- zuva rekupera kwechimwe chigadzirwa;
- zuva rakagadzirwa mudziyo chaiwo;
- iyo yakasarudzika kodhi yekodhi 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 angatsvage 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, kuti ive nechokwadi chekuitwa 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 yezvinhu zvinozivikanwa zvechishandiso chimwe nechimwe chine UDI, uye ine CHETE DI, iyo yaizoshanda sekiyi yekuwana ruzivo rwechishandiso 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 label ishandiswe pamudziyo, kana kuti anoita kuti zita remudziyo rigadziriswe, nechinangwa chekuti mudziyo ugoverwe kutengeswa pasina kuchinjwa kana kugadziridzwa kwechishandiso. label.Kuwedzerwa kwezita re, uye ruzivo rwekufonera, munhu anogovera mudziyo, pasina kuita chero imwe shanduko kune iyo label haisi shanduko yezvinangwa zvekuona kana munhu ari mucherechedzi.Kazhinji, mucherechedzi angave ari mugadziri wemudziyo, asi mucherechedzo anogona kunge ari mugadziri wezvimiro, chigadziriso chemudziyo chimwechete, chiunganidzi chekiti, 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 system yemakomputa kuburikidza neautomated process.
