Manaʻo ʻo FDA i ke alakaʻi ʻana i nā uhi huahana orthopedic

Manaʻo ʻo FDA i ke alakaʻi ʻana i nā uhi huahana orthopedic

Ke ʻimi nei ka US Food and Drug Administration (FDA) i nā ʻikepili hou mai nā mea kākoʻo orthopedic device no nā huahana me nā metala a i ʻole ka calcium phosphate coatings i kā lākou noi premarket. Ma ke ʻano kikoʻī, ke noi nei ka ʻoihana i ka ʻike e pili ana i nā mea uhi, ke kaʻina hana uhi, nā manaʻo sterility, a me ka biocompatibility i ia mau hoʻouna.

Ma Ianuali 22, ua hoʻopuka ka FDA i kahi alakaʻi kikoʻī e hōʻike ana i ka ʻikepili i koi ʻia no nā noi premarket no ka papa II a i ʻole ka papa III orthopedic me nā metala a i ʻole calcium phosphate coatings. ʻO ke alakaʻi ka manaʻo e kōkua i nā mea kākoʻo i ka hoʻokō ʻana i nā koi mana kūikawā no kekahi mau huahana papa II.

Ke kuhikuhi nei ka palapala i nā mea kākoʻo i nā kūlana kuʻikahi kūpono no ka mālama ʻana i nā koi mana kūikawā. Manaʻo ʻo FDA i ka hoʻokō ʻana i nā mana i ʻike ʻia e FDA e hāʻawi i ka palekana kūpono no ke olakino a me ka palekana.

ʻOiai ua uhi ʻia ke alakaʻi i nā ʻano uhi like ʻole, ʻaʻole ia e hoʻoponopono i kekahi mau uhi e like me ka calcium-based a i ʻole ka uhi ʻana. Eia kekahi, ʻaʻole i hoʻokomo ʻia nā ʻōlelo aʻoaʻo lāʻau lapaʻau a i ʻole biologic characterization no nā huahana i uhi ʻia.

ʻAʻole uhi ke alakaʻi i ka hoʻāʻo hana kikoʻī o ka mīkini akā ʻōlelo ʻia e pili ana i nā palapala alakaʻi kikoʻī pili pono a i ʻole ke kelepona ʻana i ka māhele loiloi kūpono no ka ʻike hou aku.

Noi ʻo FDA i ka wehewehe piha ʻana o ka uhi ʻana a hoʻoponopono i nā pilikia e like me sterility, pyrogenicity, shelf-life, packaging, labelling, a me nā hoʻokolohua lapaʻau a me ka hoʻāʻo ʻole i nā hoʻouna premarket.

Pono pū ka ʻike biocompatibility, e hōʻike ana i kona ulu nui ʻana. Hoʻoikaika ka FDA i ka loiloi ʻana i ka biocompatibility no nā mea hoʻopili maʻi āpau, me ka uhi ʻana.

Hōʻike ke alakaʻi i nā hiʻohiʻona e koi ana i kahi hoʻouna hou 510 (k) no nā huahana hoʻololi i hoʻololi ʻia, e like me ka hoʻololi ʻana i ke ʻano o ka uhi ʻana a i ʻole ka mea kūʻai aku, ka hoʻololi ʻana i ka papa uhi, a i ʻole nā ​​hoʻololi mea substrate.

Ma hope o ka hoʻopau ʻana, e hoʻololi ke alakaʻi i ke alakaʻi mua ma luna o ka hydroxyapatite-coated orthopedic implants a me ka metala plasma-sprayed coatings no ka orthopedic implants.