FDA tawm tswv yim rau kev siv cov khoom siv orthopedic

FDA tawm tswv yim rau kev siv cov khoom siv orthopedic

Lub Koom Haum Saib Xyuas Khoom Noj thiab Tshuaj ntawm Teb Chaws Asmeskas (FDA) tab tom nrhiav cov ntaub ntawv ntxiv los ntawm cov neeg txhawb nqa cov khoom siv kho pob txha rau cov khoom uas muaj cov txheej txheem hlau lossis calcium phosphate hauv lawv cov ntawv thov ua ntej kev lag luam. Tshwj xeeb, lub koom haum tab tom thov cov ntaub ntawv hais txog cov tshuaj txheej, cov txheej txheem txheej, kev txiav txim siab txog kev tsis muaj menyuam, thiab kev sib raug zoo hauv cov ntawv xa tuaj.

Thaum Lub Ib Hlis 22, FDA tau tshaj tawm cov lus qhia txog cov ntaub ntawv xav tau rau cov ntawv thov ua ntej kev lag luam rau cov khoom siv pob txha qib II lossis qib III nrog cov xim hlau lossis calcium phosphate. Cov lus qhia no lub hom phiaj yog los pab cov neeg txhawb nqa kom ua tau raws li cov kev cai tswj hwm tshwj xeeb rau qee yam khoom qib II.

Daim ntawv no qhia cov neeg txhawb nqa mus rau cov qauv kev pom zoo rau kev ua raws li cov kev cai tswj hwm tshwj xeeb. FDA hais tias kev ua raws li cov qauv uas FDA lees paub muab kev tiv thaiv txaus rau kev noj qab haus huv thiab kev nyab xeeb rau pej xeem.

Txawm hais tias cov lus qhia no hais txog ntau hom kev txheej, nws tsis hais txog qee yam kev txheej xws li cov txheej uas muaj calcium lossis cov txheej ceramic. Tsis tas li ntawd, cov lus qhia txog tshuaj lossis cov yam ntxwv ntawm cov khoom siv rau cov khoom uas tau txheej tsis suav nrog.

Cov lus qhia no tsis hais txog kev sim ua haujlwm ntawm cov khoom siv tab sis qhia kom xa mus rau cov ntaub ntawv qhia tshwj xeeb ntawm cov khoom siv lossis tiv tauj lub chaw tshuaj xyuas kom paub ntxiv.

FDA thov kom muaj kev piav qhia txog cov txheej txheem thiab daws cov teeb meem xws li kev tsis muaj menyuam, pyrogenicity, lub sijhawm khaws cia, ntim khoom, daim ntawv lo, thiab kev kuaj mob thiab tsis yog kev kuaj mob hauv kev xa khoom ua ntej kev lag luam.

Cov ntaub ntawv txog kev sib haum xeeb ntawm cov khoom siv kuj tseem ceeb heev, uas qhia txog nws qhov tseem ceeb zuj zus. FDA hais txog kev ntsuam xyuas kev sib haum xeeb ntawm cov khoom siv rau txhua yam khoom siv uas tus neeg mob siv, suav nrog cov tshuaj pleev ib ce.

Cov lus qhia piav qhia txog cov xwm txheej uas xav tau daim ntawv thov 510 (k) tshiab rau cov khoom siv hloov kho, xws li kev hloov pauv hauv txoj kev txheej lossis tus muag khoom, kev hloov pauv txheej txheej, lossis kev hloov pauv cov khoom siv substrate.

Thaum ua tiav lawm, cov lus qhia yuav hloov cov lus qhia yav dhau los ntawm cov pob txha orthopedic uas muaj hydroxyapatite thiab cov xim hlau plasma-sprayed rau cov pob txha orthopedic.