I-FDA icebisa isikhokelo malunga nokugqunywa kwemveliso yamathambo

I-FDA icebisa isikhokelo malunga nokugqunywa kwemveliso yamathambo

I-US Food and Drug Administration (FDA) ifuna idatha eyongezelelweyo kubaxhasi bezixhobo zamathambo kwiimveliso ezineengubo zesinyithi okanye ze-calcium phosphate kwizicelo zabo zangaphambi kwemarike. Ngokukodwa, i-arhente icela ulwazi ngezinto zokugquma, inkqubo yokugquma, izinto ezifunekayo ukuze zingabi nazintsholongwane, kunye nokuhambelana kwezinto eziphilayo kwezo ngxelo.

Ngomhla wama-22 kuJanuwari, i-FDA ikhuphe isikhokelo esibhaliweyo esichaza idatha efunekayo kwizicelo zangaphambi kokuthengiswa kwezixhobo ze-orthopedic zeklasi yesi-2 okanye yeklasi yesi-3 ezineengubo zesinyithi okanye ze-calcium phosphate. Esi sikhokelo sijolise ekuncedeni abaxhasi ekuhlangabezaneni neemfuno zolawulo ezikhethekileyo kwiimveliso ezithile zeklasi yesi-2.

Olu xwebhu luqondisa abaxhasi kwimigangatho efanelekileyo yokuvumelana ukuze bathobele iimfuno zolawulo ezikhethekileyo. I-FDA igxininisa ukuba ukuthobela iinguqulelo zemigangatho ezivunyiweyo yi-FDA kunika ukhuseleko olufanelekileyo kwimpilo yoluntu nokhuseleko.

Nangona esi sikhokelo sigubungela iintlobo ezahlukeneyo zokugquma, asijongani nezinto ezithile zokugquma ezifana ne-calcium okanye i-ceramic coating. Ukongeza, iingcebiso zeyeza okanye zebhayoloji zeemveliso ezigqumayo azifakwanga.

Esi sikhokelo asigubungeli uvavanyo olusebenzayo lwesixhobo esithile, kodwa sicebisa ukuba ubhekisele kumaxwebhu esikhokelo afanelekileyo esixhobo esithile okanye uqhagamshelane necandelo elifanelekileyo lophononongo ukuze ufumane ulwazi oluthe kratya.

I-FDA icela inkcazo epheleleyo yokwambathisa kwaye ijongane nemiba efana nokungabi nazintsholongwane, ukuba yingozi emzimbeni, ixesha lokuphelelwa lixesha, ukupakishwa, ukulebhelisha, kunye novavanyo lweklinikhi nolwezonyango kwiintengiso zangaphambi kokuba zithengiswe.

Ulwazi malunga nokuhambelana kwezinto eziphilayo nalo luyafuneka, nto leyo ebonisa ukubaluleka kwalo okukhulayo. I-FDA igxininisa ekuvavanyeni ukuhambelana kwezinto eziphilayo kuzo zonke izixhobo ezinxibelelana nezigulane, kuquka neengubo.

Esi sikhokelo sichaza iimeko ezifuna ukungeniswa kwe-510(k) entsha kwiimveliso zokugquma eziguquliweyo, ezinje ngotshintsho kwindlela yokugquma okanye umthengisi, utshintsho lwemaleko yokugquma, okanye utshintsho lwezinto ezisetyenziswa phantsi komhlaba.

Xa kugqityiwe, esi sikhokelo siza kuthatha indawo yesikhokelo sangaphambili kwi-hydroxyapatite-coated orthopedic implants kunye ne-metallic plasma-spray coatings kwi-orthopedic implants.