Nūhou

ʻO ka hōʻike ʻana o nā mea hana kūʻokoʻa (UDI) he "ʻōnaehana hōʻailona lāʻau kūikawā" i hoʻokumu ʻia e ka US Food and Drug Administration. ʻO ka hoʻokō ʻana i ke code hoʻopaʻa inoa e ʻike pono i nā mea lapaʻau i kūʻai ʻia a hoʻohana ʻia ma ka mākeke US, ʻaʻohe wahi i hana ʻia. . Ke hoʻokō ʻia, e hoʻopau ʻia nā lepili NHRIC a me NDC, a pono nā mea lapaʻau āpau e hoʻohana i kēia code hoʻopaʻa inoa hou ma ke ʻano he hōʻailona ma ka pahu waho o ka huahana. Ma waho aʻe o ka ʻike ʻia, pono ʻo UDI e ʻoluʻolu i ka kikokikona maʻalahi a me ka ʻike maʻalahi a me ka hopu ʻikepili (AIDC). Pono e hoʻouna ka mea nāna e hoʻopaʻa inoa i ka ʻike kikoʻī no kēlā me kēia huahana i ka "FDA International Specialty Medical Center". ʻO ka UDID hōkeoʻikepili mīkini "hiki i ka lehulehu ke nīnau a hoʻoiho i nā ʻikepili pili (me ka ʻike mai ka hana ʻana, ka hāʻawi ʻana i ka hoʻohana ʻana i nā mea kūʻai aku, a me nā mea ʻē aʻe) ma ke komo ʻana i ka waihona, akā ʻaʻole e hāʻawi ka waihona i ka ʻike mea hoʻohana. 

ʻO ka nui he code i loaʻa nā helu a i ʻole nā ​​leka. Loaʻa iā ia kahi code identification device (DI) a me kahi code identification code (PI).

ʻO ka code identification device he code paʻa paʻa, e komo pū ana ka ʻike o nā limahana hoʻokele lepili, ka mana kikoʻī a i ʻole ke ʻano o ka hāmeʻa, ʻoiai ʻaʻole i kuhikuhi kūikawā ʻia ka code ʻike huahana, a me ka helu pūʻulu hana hana, helu serial, lā hana, lā pau a me ka hoʻokele ʻana ma ke ʻano he mea hana. ʻO ke code ʻike kūʻokoʻa o ka huahana cell tissue ola.

A laila, e kamaʻilio e pili ana iā GUDID, Global Unique Device Identification System (GUDID), FDA International Special Medical Device Identification Library. Hoʻolaha ʻia ka waihona ma o ka ʻōnaehana nīnau AccessGUDID. ʻAʻole hiki iā ʻoe ke hoʻokomo pololei i ka code DI o ka UDI i ka ʻike lepili ma ka ʻaoʻao pūnaewele waihona e ʻike ai i ka ʻike huahana, akā hiki iā ʻoe ke ʻimi i nā ʻano o kekahi mea lapaʻau (e like me ka mea hoʻohana, ʻoihana a i ʻole inoa kālepa, inoa maʻamau, a i ʻole ke kumu hoʻohālike a me ka mana o ka mea hana). ), akā pono e hoʻomaopopo ʻaʻole hāʻawi kēia waihona i nā code PI no nā polokalamu.

ʻO ia hoʻi, ka wehewehe ʻana o UDI: Unique Device Identification (UDI) he hōʻailona i hāʻawi ʻia i kahi lāʻau lapaʻau i loko o kona pōʻai ola, a ʻo ia wale nō ka "kāleka ʻike" i loko o ke kaulahao lako huahana. ʻO ka hoʻohana ʻana i ka honua holoʻokoʻa o ka UDI i hoʻohui ʻia a me ka maʻamau ka mea e pono ai ka hoʻomaikaʻi ʻana i ke kaulahao lako a me ka pono o ka hana; he mea pono e hoemi i na koina hana; he mea maikaʻi ka hoʻomaopopo ʻana i ka hāʻawi ʻana a me ka hoʻololi ʻana; he mea maikaʻi i ka nānā ʻana i nā hanana ʻino a me ka hoʻomanaʻo ʻana i nā huahana hemahema, hoʻomaikaʻi i ka maikaʻi o nā lawelawe lapaʻau, a me ka pale ʻana i ka palekana o nā maʻi.