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tumira zvekurapaYakasarudzika mudziyo identification (UDI) i "special medical device identification system" yakagadzwa neUS Food and Drug Administration. Kuitwa kwekodhi yekunyoresa ndeyekunyatsoona michina yekurapa inotengeswa uye inoshandiswa mumusika weUS, zvisinei kuti inogadzirwa kupi. . Kana zvangoitwa, zvinyorwa zveNHRIC neNDC zvichabviswa, uye midziyo yese yekurapa inoda kushandisa iyi kodhi nyowani yekunyoresa sechiratidzo papakeji yekunze yechigadzirwa. Pamusoro pekuonekwa, UDI inofanirwa kugutsa zvese zviri pachena zvinyorwa uye otomatiki chiziviso uye data capture (AIDC). Iye anoona nezvekunyora mudziyo anofanirawo kutumira iwo chaiwo ruzivo rwechigadzirwa chimwe nechimwe ku "FDA International Specialty Medical Center". Dhatabhesi yekuzivikanwa kwemudziyo UDID ”inogonesa veruzhinji kubvunza uye kudhawunirodha data rakakodzera (kusanganisira ruzivo kubva mukugadzira, kugovera kune kushandiswa kwevatengi, nezvimwewo) nekuwana dhatabhesi, asi dhatabhesi haipe ruzivo rwemushandisi wemudziyo. 

Kunyanya kodhi ine nhamba kana mavara. Iyo ine mudziyo wekuzivikanwa kodhi (DI) uye kodhi yekuzivikanwa kodhi (PI).

Iyo kodhi yekuzivikanwa kwemudziyo ndeye inosungirwa yakatarwa kodhi, iyo inosanganisira iyo ruzivo rwevashandi vemanejimendi, iyo chaiyo vhezheni kana modhi yechigadzirwa, nepo kodhi yekuzivikanwa yechigadzirwa isina kunyatso kutaurwa, uye inosanganisira iyo yekugadzira mudziyo batch nhamba, serial nhamba, zuva rekugadzira, zuva rekupera uye manejimendi semudziyo. Iyo yakasarudzika kodhi kodhi yemhenyu cell tissue chigadzirwa.

Tevere, ngatitaure nezve GUDID, Global Unique Device Identification System (GUDID), FDA International Special Medical Device Identification Library. Iyo database inoitwa pachena kuburikidza neAccessGUDID query system. Kwete chete iwe unogona kuisa zvakananga DI kodhi yeUDI mune yeruzivo ruzivo pane dhatabhesi peji rewebhu kuti uwane ruzivo rwechigadzirwa, asi iwe unogona zvakare kutsvaga kuburikidza nehunhu hwechero mudziyo wekurapa (senge chiziviso chemudziyo, kambani kana zita rekutengesa, generic zita, kana modhi neshanduro yechishandiso). ), asi zvakakosha kuziva kuti dhatabhesi iyi haipe maPI makodhi emidziyo.

Kureva kuti, tsananguro yeUDI: Unique Device Identification (UDI) chiziviso chinopihwa kuchishandiso chekurapa mukati mehupenyu hwayo hwose, uye ndiyo yega "chitupa" mucheni yekugovera zvigadzirwa. Kugamuchirwa kwepasi rose kweUDI yakabatana uye yakajairwa inobatsira kuvandudza kujeka kweketani uye kushanda zvakanaka; zvinobatsira kuderedza mari yekushandisa; zvinobatsira kuziva kugovana ruzivo nekuchinjana; zvinobatsira kutarisisa zviitiko zvakashata uye kurangarira zvigadzirwa zvisina kukwana, kuvandudza kunaka kwemabasa ekurapa, nekudzivirira kuchengetedza varwere.


Nguva yekutumira: Kubvumbi-28-2022