FDA itanga ubuyobozi kubijyanye no gutwikira ibicuruzwa

FDA itanga ubuyobozi kubijyanye no gutwikira ibicuruzwa

Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA) kirashaka amakuru y’inyongera ku baterankunga b’ibikoresho bya orthopedic kubicuruzwa bifite metallic cyangwa calcium fosifate ikozwe mubisabwa mbere. By'umwihariko, ikigo kirasaba amakuru kubintu bitwikiriye, inzira yo gutwikira, gutekereza kuri sterile, hamwe na biocompatibilité mubyoherejwe.

Ku ya 22 Mutarama, FDA yasohoye umushinga w'ubuyobozi werekana amakuru asabwa kugira ngo usabe ibyateganijwe mbere yo mu cyiciro cya II cyangwa icyiciro cya gatatu cy'amagufwa ya orthopedic hamwe na fosifate ya calcium cyangwa calcium. Ubuyobozi bugamije gufasha abaterankunga kubahiriza ibisabwa byihariye byo kugenzura ibicuruzwa bimwe na bimwe byo mu cyiciro cya II.

Inyandiko iyobora abaterankunga ku bipimo byumvikanyweho bijyanye no kubahiriza ibisabwa byihariye byo kugenzura. FDA ishimangira ko kubahiriza verisiyo yemewe na FDA itanga uburinzi buhagije kubuzima rusange n’umutekano.

Mugihe ubuyobozi bukubiyemo ubwoko butandukanye bwo gutwikira, ntabwo bukemura ibintu bimwe na bimwe nka calcium ishingiye kuri calcium cyangwa ceramic. Byongeye kandi, ibiyobyabwenge cyangwa ibinyabuzima biranga ibicuruzwa bisizwe ntabwo birimo.

Ubuyobozi ntabwo bukubiyemo igeragezwa ryibikoresho byihariye ariko biratanga inama yo kwifashisha inyandiko zikoreshwa mu bikoresho byihariye cyangwa kuvugana n’ishami rishinzwe gusuzuma kugira ngo umenye andi makuru.

FDA irasaba ibisobanuro birambuye byerekana igifuniko kandi ikemura ibibazo nka sterité, pyrogenicity, ubuzima-bwo kubaho, gupakira, kuranga, hamwe no kwipimisha kwa clinique na non-clinique mubyoherejwe mbere.

Ibisobanuro bya biocompatibilité nabyo birakenewe, byerekana akamaro kayo. FDA ishimangira gusuzuma biocompatibilité kubikoresho byose byita ku barwayi, harimo na coatings.

Ubuyobozi bugaragaza ibintu bisaba 510 (k) gutanga ibicuruzwa bishya byahinduwe, nk'impinduka muburyo bwo gutwikira cyangwa umucuruzi, guhindura ibice, cyangwa guhindura ibintu.

Iyo birangiye, ubuyobozi buzasimbuza ubuyobozi bwabanje kubijyanye na hydroxyapatite-yatewe na orthopedic yatewe hamwe na plasma-plasma yatewe-yatewe na orthopedic.