FDA inokurudzira kutungamira pane orthopedic chigadzirwa coating

FDA inokurudzira kutungamira pane orthopedic chigadzirwa coating

Iyo US Food and Drug Administration (FDA) iri kutsvaga imwe data kubva kune orthopedic mudziyo vanotsigira zvigadzirwa zvine simbi kana calcium phosphate coating mu premarket application. Kunyanya, iyo agency iri kukumbira ruzivo rwekupfekedza zvinhu, maitiro ekupfekedza, kufunga nezve sterility, uye biocompatibility mune izvo zvinotumirwa.

Musi waNdira 22, iyo FDA yakapa dhizaini nhungamiro inotsanangura iyo data inodiwa yepremarket application yekirasi II kana kirasi III midziyo yemapfupa ane simbi kana calcium phosphate coatings. Nhungamiro iyi ine chinangwa chekubatsira vatsigiri mukusangana nezvinodiwa zvekutonga kune zvimwe zvigadzirwa zvekirasi II.

Gwaro rinotungamira vatsigiri kune akakodzera kubvumirana zviyero zvekuomerera kune yakakosha kutonga zvinodiwa. FDA inosimbisa kuti kuenderana neFDA-inocherechedzwa shanduro dzeyero inopa dziviriro yakakwana yehutano hweveruzhinji nekuchengetedzeka.

Nepo nhungamiro ichivhara marudzi akasiyana ekuputira, haigadzirise mamwe machira senge calcium-based kana ceramic coatings. Pamusoro pezvo, zvinodhaka kana biologic maitiro ekurudziro ezvigadzirwa zvakavharwa hazvina kubatanidzwa.

Iyo nhungamiro haivharidzire mudziyo-chainoshanda kuyedza asi inopa zano kunongedzera kune anoshanda-yakananga magwaro ekutungamira kana kubata chikamu chakakodzera chekuongorora kuti uwane rumwe ruzivo.

FDA inokumbira tsananguro yakazara yekupfekedza uye inogadzirisa nyaya dzakadai sekubereka, pyrogenicity, sherufu-hupenyu, kurongedza, kunyora, uye kukiriniki uye kusiri kwekiriniki kuyedzwa mukutumirwa kwekutanga.

Ruzivo rweBiocompatibility runodiwa zvakare, kuratidza kukosha kwayo kuri kukura. FDA inosimbisa kuongorora biocompatibility yezvinhu zvese zvinobata murwere, kusanganisira machira.

Nhungamiro inodonongodza mamiriro anoda 510 (k) kuendesa kune yakagadziridzwa zvigadzirwa zvekunamira, senge shanduko yenzira yekupfekedza kana mutengesi, kuchinjisa jira rekuchinja, kana substrate zvinhu shanduko.

Pakupedzwa, kutungamira kunotsiva kutungamira kwekare pane hydroxyapatite-yakavharwa orthopedic implants uye esimbi plasma-yakapfapfaidzwa machira emapfupa emapfupa.