I-FDA iphakamisa isiqondiso mayelana nokugqoka imikhiqizo yamathambo

I-FDA iphakamisa isiqondiso mayelana nokugqoka imikhiqizo yamathambo

I-US Food and Drug Administration (FDA) ifuna idatha eyengeziwe kubaxhasi bamadivayisi amathambo ngemikhiqizo enezembozo zensimbi noma ze-calcium phosphate ekusetshenzisweni kwayo kwangaphambi kwemakethe. Ngokukhethekile, le nhlangano icela ulwazi ngezinto zezembozo, inqubo yezembozo, izinto eziphathelene nokungabi namagciwane, kanye nokuhambisana kwezinto eziphilayo ekuthunyelweni okunjalo.

Ngomhlaka-22 Januwari, i-FDA yakhipha isiqondiso esiwuhlaka esichaza idatha edingekayo yezicelo zangaphambi kokuthengiswa kwamadivayisi e-orthopedic ekilasi II noma ekilasi III anezembozo ze-metallic noma ze-calcium phosphate. Lesi siqondiso sihlose ukusiza abaxhasi ekuhlangabezaneni nezidingo zokulawula ezikhethekile zemikhiqizo ethile yekilasi II.

Lo mbhalo uqondisa abaxhasi ezindinganisweni ezifanele zokuvumelana ngokunamathela ezidingweni zokulawula ezikhethekile. I-FDA igcizelela ukuthi ukuhambisana nezinguqulo zezindinganiso eziqashelwa yi-FDA kunikeza isivikelo esanele sempilo yomphakathi nokuphepha.

Nakuba lesi siqondiso sihlanganisa izinhlobo ezahlukene zokumboza, asibheki ukumboza okuthile okufana nokumboza okusekelwe ku-calcium noma kwe-ceramic. Ngaphezu kwalokho, izincomo zokuchaza izidakamizwa noma zebhayoloji zemikhiqizo embozwe azifakiwe.

Lesi siqondiso asihlanganisi ukuhlolwa kokusebenza kwedivayisi ethile kodwa sicebisa ukuthi ubhekisele kumadokhumenti afanele esiqondiso sedivayisi ethile noma uxhumane nesigaba sokubuyekeza esifanele ukuze uthole ulwazi olwengeziwe.

I-FDA icela incazelo ephelele yengubo futhi ibhekana nezinkinga ezifana nokungazali, ukuqina kwesikhumba, isikhathi sokuphelelwa yisikhathi, ukupakishwa, ukulebula, kanye nokuhlolwa kwezokwelapha kanye nokungekona okwezokwelapha ekuthunyelweni kwangaphambi kwemakethe.

Ulwazi lokuhambisana kwezinto eziphilayo nalo luyadingeka, okubonisa ukubaluleka kwalo okukhula. I-FDA igcizelela ukuhlola ukuhambisana kwazo zonke izinto ezithinta isiguli, okuhlanganisa nokwemboza.

Isiqondiso sichaza izimo ezidinga ukuhanjiswa okusha kwe-510(k) kwemikhiqizo yokumboza eguquliwe, njengokushintsha kwendlela yokumboza noma umthengisi, ukuguqulwa kwesendlalelo sokumboza, noma izinguquko zezinto ze-substrate.

Uma sekuqediwe, lesi siqondiso sizothatha indawo yesiqondiso sangaphambilini mayelana nokufakelwa kwamathambo okumbozwe nge-hydroxyapatite kanye nokufakelwa kwe-plasma okufakwe ngensimbi kokufakelwa kwamathambo.