FDA itanga amabwiriza ku bijyanye no gusiga ibikoresho by'amagufwa

FDA itanga amabwiriza ku bijyanye no gusiga ibikoresho by'amagufwa

Ikigo gishinzwe ibiribwa n'imiti muri Amerika (FDA) kirimo gushaka andi makuru aturutse ku baterankunga b'ibikoresho by'amagufwa ku bicuruzwa bifite irangi rya calcium cyangwa calcium phosphate mu bikorwa byabyo bya mbere y'isoko. By'umwihariko, ikigo kirasaba amakuru ku bintu bisiga irangi, uburyo irangi rikorwa, ibijyanye no kutabyara, ndetse n'uburyo ibipimo bihuza n'ibindi muri ibyo bicuruzwa.

Ku ya 22 Mutarama, FDA yasohoye umushinga w’amabwiriza agaragaza amakuru akenewe ku bikoresho bya orthopedique byo mu cyiciro cya kabiri cyangwa icya gatatu bifite irangi rya metali cyangwa calcium phosphate. Ayo mabwiriza agamije gufasha abaterankunga kuzuza ibisabwa byihariye byo kugenzura ibicuruzwa bimwe na bimwe byo mu cyiciro cya kabiri.

Iyi nyandiko iyobora abaterankunga ku mahame shingiro agenga kubahiriza ibisabwa byihariye byo kugenzura. FDA ishimangira ko kubahiriza amahame shingiro yemewe na FDA bitanga uburinzi buhagije ku buzima rusange n'umutekano.

Nubwo ubuyobozi buvuga ku bwoko butandukanye bwo gusiga, ntibuvuga ku gusiga bimwe na bimwe nko gusiga bishingiye kuri kalisiyumu cyangwa se kuri ceramic. Byongeye kandi, nta nama zijyanye n'imiti cyangwa ibyatsi ku bicuruzwa bisize.

Ubwo buyobozi ntibukubiyemo isuzuma ry’imikorere ry’igikoresho runaka, ahubwo bugira inama yo kureba inyandiko z’ubuyobozi zijyanye n’igikoresho runaka cyangwa kuvugana n’ishami rishinzwe isuzuma rikwiye kugira ngo ubone amakuru arambuye.

FDA irasaba ibisobanuro birambuye ku bijyanye n'ipfundikizo kandi igakemura ibibazo nko kutabyara, kuba pyrogenicity, igihe cyo kubikwa, gupakira, kwandikaho, n'ibizamini byo kwa muganga n'ibitari ibya muganga mu byoherejwe mbere y'isoko.

Amakuru yerekeye imikorere y’umubiri arakenewe, agaragaza akamaro kayo gakomeje kwiyongera. FDA ishimangira gusuzuma imikorere y’umubiri ku bikoresho byose bihuza umurwayi, harimo n’ibipfuka.

Ubuyobozi bugaragaza ibintu bisaba ko habaho 510 (k) nshya ku bicuruzwa byahinduwe byo gusiga, nko guhindura uburyo bwo gusiga cyangwa umucuruzi, guhindura urwego rwo gusiga, cyangwa impinduka ku bikoresho bya substrate.

Nyuma yo kurangiza, ubuyobozi buzasimbura ubuyobozi bwabanje ku birebana n’implants za orthopedique zikozwe muri hydroxyapatite hamwe n’implants za plasma zikozwe muri metali ku bijyanye n’implants za orthopedique.