I-FDA iphakamisa isiqondiso mayelana nezingubo zomkhiqizo wamathambo

I-FDA iphakamisa isiqondiso mayelana nezingubo zomkhiqizo wamathambo

I-US Food and Drug Administration (i-FDA) ifuna idatha eyengeziwe kubaxhasi bemishini ye-orthopedic yemikhiqizo enezimbotshana ze-metallic noma ze-calcium phosphate ezinhlelweni zabo zokudayisa. Ikakhulukazi, i-ejensi icela ulwazi mayelana nezinto zokumboza, inqubo yokumboza, ukucatshangelwa kobunyumba, kanye nokuhambisana kwe-biocompatibility kulezo ziphakamiso.

Ngomhla zingama-22 kuMasingana, i-FDA yakhipha isiqondiso esisalungiswa esichaza idatha edingekayo yezicelo zemakethe zangaphambi kwemakethe zeklasi II noma i-class III yemishini yamathambo enezimbotshana ze-metallic noma ze-calcium phosphate. Umhlahlandlela uhlose ukusiza abaxhasi ekuhlangabezaneni nezimfuneko zokulawula ezikhethekile zemikhiqizo ethile yesigaba II.

Lo mbhalo uqondisa abaxhasi emazingeni okuvumelana afanelekile okuhambisana nezidingo ezikhethekile zokulawula. I-FDA igcizelela ukuthi ukuhambisana nezinguqulo zamazinga eziqashelwa yi-FDA kunikeza ukuvikeleka okwanele kwezempilo nokuphepha komphakathi.

Ngenkathi isiqondiso sihlanganisa izinhlobo zokumboza ezihlukahlukene, asibheki izinto zokumboza ezifana ne-calcium-based noma i-ceramic coatings. Ukwengeza, izincomo zezidakamizwa noma ze-biologic zemikhiqizo ehlanganisiwe azifakiwe.

Isiqondiso asibandakanyi ukuhlola kokusebenza okuqondene nedivayisi kodwa siluleka ngokubhekisela kumadokhumenti esiqondiso esiqondene nedivayisi ethile noma ukuxhumana nesigaba esifanelekile sokubuyekeza ukuze uthole ulwazi olwengeziwe.

I-FDA icela incazelo ebanzi yokunameka futhi ibhekane nezindaba ezinjengobunyumba, i-pyrogenicity, impilo yeshalofu, ukupakishwa, ukulebula, nokuhlolwa komtholampilo nokungekona komtholampilo ekuthunyelweni kwasemakethe.

Ulwazi lwe-Biocompatibility nalo luyadingeka, okubonisa ukubaluleka kwalo okukhulayo. I-FDA igcizelela ukuhlola ukuhambelana kwe-biocompatibility yazo zonke izinto zokuxhumana nesiguli, okuhlanganisa nama-coatings.

Isiqondiso siveza izimo ezidinga ukuthunyelwa okusha okungu-510(k) kwemikhiqizo yokuhlanganisa eshintshiwe, efana noshintsho endleleni yokumboza noma umthengisi, ukuguqulwa kongqimba, noma izinguquko ze-substrate.

Lapho sekuphothulwe, isiqondiso sizothatha indawo yesiqondiso sangaphambilini ekufakweni kwamathambo okuhlanganiswe nge-hydroxyapatite kanye nezingubo zensimbi ezifafazwe nge-plasma zokufakelwa kwamathambo.