FDA tshaj tawm cov lus qhia txog cov khoom siv orthopedic txheej

FDA tshaj tawm cov lus qhia txog cov khoom siv orthopedic txheej

US Food and Drug Administration (FDA) tab tom nrhiav cov ntaub ntawv ntxiv los ntawm cov khoom siv orthopedic txhawb nqa rau cov khoom siv hlau lossis calcium phosphate coatings hauv lawv daim ntawv thov ua ntej. Tshwj xeeb, lub koom haum tab tom thov cov ntaub ntawv ntawm cov tshuaj txheej txheej, txheej txheem txheej txheej, kev txiav txim siab tsis muaj menyuam, thiab biocompatibility hauv cov ntawv xa tawm.

Thaum Lub Ib Hlis 22, FDA tau tshaj tawm tsab ntawv qhia qhia txog cov ntaub ntawv xav tau rau cov ntawv thov ua ntej rau chav kawm II lossis chav kawm III orthopedic cov cuab yeej siv hlau lossis calcium phosphate coatings. Kev taw qhia lub hom phiaj los pab cov neeg txhawb nqa kom tau raws li kev tswj hwm tshwj xeeb rau qee yam khoom siv hauv chav kawm II.

Cov ntaub ntawv qhia cov neeg txhawb nqa rau cov qauv kev pom zoo uas cuam tshuam rau kev ua raws li kev tswj hwm tshwj xeeb. FDA hais ntxiv tias kev ua raws li FDA lees paub cov qauv ntawm cov qauv muab kev tiv thaiv txaus rau pej xeem kev noj qab haus huv thiab kev nyab xeeb.

Thaum cov kev taw qhia npog ntau hom txheej, nws tsis hais txog qee cov txheej txheem xws li calcium-based lossis ceramic txheej. Tsis tas li ntawd, cov lus pom zoo siv tshuaj lossis biologic cim rau cov khoom coated tsis suav nrog.

Cov kev taw qhia tsis suav nrog cov cuab yeej tshwj xeeb kev ntsuas kev ua haujlwm tab sis qhia txog kev xa mus rau cov ntaub ntawv qhia txog cov cuab yeej siv tshwj xeeb lossis hu rau lub chaw saib xyuas tsim nyog rau cov lus qhia ntxiv.

FDA thov cov lus piav qhia dav dav ntawm cov txheej txheem thiab hais txog cov teeb meem xws li tsis muaj menyuam, pyrogenicity, txee lub neej, ntim khoom, daim ntawv lo, thiab tshuaj ntsuam xyuas thiab tsis-kuaj kho hauv kev xa khoom ua ntej.

Cov ntaub ntawv biocompatibility kuj tseem xav tau, uas qhia txog nws qhov tseem ceeb zuj zus. FDA hais txog kev ntsuam xyuas biocompatibility rau txhua tus neeg mob cov ntaub ntawv sib cuag, suav nrog cov txheej txheem.

Cov kev taw qhia qhia txog cov xwm txheej uas yuav tsum tau ua 510 (k) xa tawm tshiab rau cov khoom siv txheej txheej hloov kho, xws li kev hloov pauv txheej txheej lossis cov neeg muag khoom, kev hloov txheej txheej txheej, lossis hloov cov khoom siv substrate.

Thaum ua tiav, kev taw qhia yuav hloov cov kev taw qhia yav dhau los ntawm hydroxyapatite-coated orthopedic implants thiab metallic plasma-sprayed coatings rau orthopedic implants.