Mu 2013, bungwe la Food and Drug Administration (FDA) lidatulutsa lamulo lomaliza lokhazikitsa njira yapadera yozindikiritsira zida zomwe zidapangidwa kuti zizizindikiritsa zida moyenera pogawa ndikugwiritsa ntchito.Lamulo lomaliza limafuna kuti zolembera zida ziphatikizepo chozindikiritsa chapadera cha chipangizo (UDI) pa zilembo za zida ndi mapaketi, kupatula pomwe lamuloli limapereka chosiyana kapena china.UDI iliyonse iyenera kuperekedwa m'mawu osavuta komanso m'mawonekedwe omwe amagwiritsa ntchito ukadaulo wozindikiritsa komanso kujambula deta (AIDC).UDI idzafunikanso kuikidwa chizindikiro mwachindunji pa chipangizo chomwe chimagwiritsidwa ntchito kangapo, ndipo chiyenera kukonzedwanso musanagwiritse ntchito.Madeti olembedwa pazida ndi phukusi akuyenera kuperekedwa mumpangidwe wokhazikika womwe umagwirizana ndi miyezo yapadziko lonse lapansi komanso machitidwe apadziko lonse lapansi.
UDI ndi nambala yapadera ya manambala kapena alphanumeric yomwe ili ndi magawo awiri:
- chozindikiritsa chipangizo (DI), gawo lofunikira, lokhazikika la UDI lomwe limazindikiritsa cholembera ndi mtundu kapena mtundu wa chipangizocho, ndi
- chizindikiritso chopanga (PI), gawo lokhazikika, losinthika la UDI lomwe limazindikiritsa chimodzi kapena zingapo mwa izi zikaphatikizidwa pa lebulo la chipangizo:
- nambala kapena nambala ya batchi yomwe chipangizocho chinapangidwira;
- nambala yachinsinsi ya chipangizo china;
- tsiku lotha ntchito ya chipangizo china;
- tsiku limene chipangizo china chinapangidwa;
- code yodziwika yodziwika yofunikira ndi §1271.290 (c) ya selo laumunthu, minofu, kapena ma cellular ndi mankhwala opangidwa ndi minofu (HCT / P) yoyendetsedwa ngati chipangizo.
Ma UDI onse ayenera kuperekedwa pansi pa dongosolo loyendetsedwa ndi bungwe lopereka zovomerezeka la FDA.Lamuloli limapereka njira yomwe wopemphayo angafunefune kuvomerezedwa ndi FDA, limatchula zambiri zomwe wopemphayo ayenera kupereka kwa FDA, ndipo njira zomwe FDA idzagwiritse ntchito pakuwunika ntchito.
Zina mwazosiyana ndi zina zafotokozedwa mu lamulo lomaliza, kuonetsetsa kuti ndalama ndi zolemetsa zimakhala zochepa.Dongosolo la UDI lidzayamba kugwira ntchito pang'onopang'ono, kwa zaka zisanu ndi ziwiri, kuti zitsimikizire kukhazikitsidwa bwino komanso kufalitsa ndalama ndi zolemetsa zogwirira ntchito pakapita nthawi, m'malo mongotengeka nthawi imodzi.
Monga gawo la dongosololi, olemba zidawa akuyenera kutumiza zidziwitso ku FDA yoyendetsedwa ndi FDA ya Global Unique Device Identification Database (GUDID).GUDID iphatikizanso zinthu zodziwikiratu pachida chilichonse chokhala ndi UDI, ndipo imakhala ndi DI YOKHA, yomwe ingakhale chinsinsi chopezera chidziwitso cha chipangizocho munkhokwe.Ma PI sali gawo la GUDID.
A FDA akupanga zambiri za izi kuti zipezeke kwa anthu ku AccessGUDID, kudzera mu mgwirizano ndi National Library of Medicine.Ogwiritsa ntchito zida zamankhwala amatha kugwiritsa ntchito AccessGUDID kufufuza kapena kukopera zambiri za zida.UDI sikuwonetsa, ndipo nkhokwe ya GUDID sikhala ndi chidziwitso chilichonse chokhudza yemwe amagwiritsa ntchito chipangizocho, kuphatikiza zinsinsi zaumwini.
Kuti mumve zambiri pa GUDID ndi UDI chonde onani tsamba la UDI Resources komwe mungapeze maulalo a maphunziro othandiza, malangizo, ndi zida zina zokhudzana ndi UDI.
A 'labeler' ndi munthu aliyense amene amapangitsa kuti lebulo igwiritsidwe ntchito pa chipangizocho, kapena amene amapangitsa kuti chizindikiro cha chipangizocho chisinthidwe, ndi cholinga chakuti chipangizocho chigawidwe malonda popanda kusinthidwa kapena kusinthidwa. chizindikiro.Kuwonjezera dzina la, ndi zambiri kukhudzana kwa, munthu amene amagawa chipangizo, popanda kusintha zina pa chizindikiro si kusinthidwa kwa zolinga kudziwa ngati munthu ndi wolemba.Nthawi zambiri, cholembera chingakhale chopanga chipangizocho, koma cholembera chikhoza kukhala chojambula chokhazikika, chosinthira chimodzi chogwiritsa ntchito kamodzi, chophatikiza zida zosavuta, chopakiranso, kapena cholemberanso.
Automatic identification and data capture (AIDC) imatanthawuza ukadaulo uliwonse womwe umapereka UDI kapena chozindikiritsa chipangizo cha chipangizo mumpangidwe womwe ungalowetsedwe mu rekodi yamagetsi ya odwala kapena makina ena apakompyuta kudzera pakompyuta.
