Amakuru

Ibyerekezo bitatu byibikoresho byubuvuzi ibintu bibi byagarutsweho

Ububikoshingiro, izina ryibicuruzwa nizina ryabayikoze nuburyo butatu bwingenzi bwibikoresho byubuvuzi bikurikirana ibyabaye.

Kugarura ibikoresho byubuvuzi ibintu bibi bishobora gukorwa mubyerekezo byububiko, kandi ububiko butandukanye bufite ibiranga. Kurugero, ibikoresho byubuvuzi byubushinwa amakuru yamakuru yamenyesheje buri gihe amenyesha ibintu bibi byubwoko runaka bwibicuruzwa, mugihe ibikoresho byubuvuzi ibintu bibi byanditswe mubikoresho byubuvuzi byamenyeshejwe cyane cyane biva muri Amerika, Ubwongereza, Ositaraliya na Kanada ibikoresho byubuvuzi kuburira cyangwa kwibutsa amakuru yo murugo n'akarere ntabwo ari amakuru yatangajwe murugo; Ububiko bwa MAUDE bwa Reta zunzubumwe zamerika nububiko bwuzuye, mugihe cyose ibikoresho byubuvuzi ibintu bibi byavuzwe hakurikijwe amabwiriza ya FDA yo muri Amerika bizinjira mububiko; ibikoresho byubuvuzi ibintu bibi / kwibuka / kumenyesha amakuru ajyanye nububiko bwibihugu n'uturere nk'Ubwongereza, Kanada, Ositaraliya n'Ubudage bizajya bivugururwa buri gihe. Kugarura ibikoresho byubuvuzi ibintu bibi mubyerekezo byububiko, birashobora kugenzurwa ukurikije ijambo ryibanze, kandi birashobora no kugarurwa neza mugabanya igihe cyangwa ijambo ryibanze.

Kugirango ukore ibikoresho byubuvuzi ibintu bibi byagarutsweho mu cyerekezo cyizina ryibicuruzwa, urashobora kwinjiza izina ryibikoresho byubuvuzi byateganijwe kurupapuro rwabigenewe kugirango ubone ibisubizo, kandi mubisanzwe ntukeneye kwinjiza izina ryibicuruzwa byihariye.

Mugihe ushakisha ukurikije izina ryibikoresho byubuvuzi, niba uruganda arirwo ruganda ruterwa inkunga n’amahanga, birakenewe ko twita ku buryo butandukanye bwo kwerekana izina ry’ikigo, nk'imanza, amagambo ahinnye, n'ibindi.

Isesengura ryibintu bibi byakuwe mubibazo byihariye

Ibikubiye mubikoresho byubuvuzi raporo yibikorwa byubushakashatsi bishobora kuba birimo ariko ntibigarukira gusa muri make intego yo gukurikirana na gahunda yo gukurikirana ibikoresho byubuvuzi bibi; gukurikirana inkomoko y'amakuru; igihe cyagenwe cyibintu byagarutsweho; umubare wibyabaye bibi; inkomoko ya raporo; ibitera ibintu bibi; ingaruka zibyabaye; igipimo cyibintu bitandukanye bibi; ingamba zafashwe kubintu bibi; na; Igenzura ryamakuru nigikorwa cyo kugenzura birashobora gutanga imbaraga zo gusuzuma tekiniki, kugenzura ibicuruzwa nyuma yo kugurisha ibicuruzwa, cyangwa gucunga ibyago byinganda zikora.

Urebye umubare munini wamakuru, amakuru 219 yagaruwe muguhagarika “producode” kugeza muri kamena 2019. Nyuma yo gusiba ibice 19 byamakuru atari ibintu bibi, ibice 200 bisigaye byashyizwe mubisesengura. Amakuru ari muri data base yakuweho umwe umwe, ukoresheje software ya Microsoft Excel yakusanyije amakuru aturuka kuri raporo, amakuru ajyanye nibikoresho byubuvuzi (harimo izina ryuwabikoze, izina ryibicuruzwa, ubwoko bwibikoresho byubuvuzi, ibibazo byubuvuzi) , igihe cyo kubaho cyibintu bibi, igihe FDA yakiriye ibintu bibi, ubwoko bwibintu bibi, ibitera ibintu bibi, hanyuma igasesengura aho ibintu byabereye Impamvu nyamukuru zitera ibintu bibi byabaye incamake, kandi ingamba zo kunoza zari shyira imbere uhereye kumikorere, gushushanya prothèse hamwe nubuforomo nyuma yibikorwa. Isesengura ryavuzwe haruguru nibirimo birashobora gukoreshwa nkibisobanuro byisesengura ryibikoresho byubuvuzi bisa nibintu bibi.

Isesengura ryibintu bibi kugirango tunoze urwego rwo kugenzura ingaruka

Incamake nisesengura ryibikoresho byubuvuzi ibintu bibi bifite akamaro kanini kubiro bishinzwe kugenzura ibikoresho byubuvuzi, inganda n’ibikorwa n’abakoresha kugira ngo bagenzure ingaruka. Ku ishami rishinzwe kugenzura, gushyiraho no kuvugurura amabwiriza y’ibikoresho by’ubuvuzi, amategeko n’inyandiko zisanzwe birashobora gukorwa hamwe n’ibisubizo by’isesengura ry’ibintu bibi, kugira ngo igenzura ry’imicungire y’imicungire y’ibikoresho by’ubuvuzi bifite amategeko n'amabwiriza agomba gukurikiza. . Shimangira kugenzura ibicuruzwa byamamaza ibicuruzwa byubuvuzi, gukusanya no kuvuga muri make ibintu bibi, kuburira no kwibuka amakuru yibikoresho byubuvuzi buri gihe, kandi ugatangaza itangazo mugihe. Muri icyo gihe, shimangira ubugenzuzi bwabakora ibikoresho byubuvuzi, usuzume imikorere yabyo, kandi ugabanye neza amahirwe yibintu bituruka kumasoko. Byongeye kandi, dukwiye gukomeza guteza imbere ubushakashatsi bwa siyansi kubijyanye no kugenzura ibikoresho byubuvuzi no kubaka sisitemu yo gusuzuma ishingiye ku kugenzura neza ingaruka.

Ibigo byubuvuzi bigomba gushimangira amahugurwa nubuyobozi, kugirango abaganga bashobore kumenya neza imikorere isanzwe yubumenyi nubuhanga bwo gukoresha ibikoresho, kandi bigabanye amahirwe yibintu bibi. Kugira ngo turusheho gushimangira ihuriro ry’ubuvuzi n’ubuhanga, kandi dusabe abaganga kuvugana n’abashakashatsi bashinzwe ibikoresho by’ubuvuzi ku bibazo bigaragara mu ikoreshwa ry’amavuriro ry’ibikoresho by’ubuvuzi, kugira ngo abaganga bashobore gusobanukirwa neza n’ibikoresho by’ubuvuzi byakoreshejwe, kandi banafasha ibikoresho byubuvuzi bishushanya abashakashatsi kugirango bashushanye neza cyangwa batezimbere ibikoresho byubuvuzi. Byongeye kandi, ubuyobozi bwo gusubiza mu buzima busanzwe amavuriro bugomba gushimangirwa kwibutsa abarwayi ingingo zingenzi zo kwirinda kunanirwa hakiri kare bitewe n’ibikorwa bidashyitse cyangwa imikorere idakwiye. Muri icyo gihe, abaganga bagomba kunoza imyumvire yabo y’ibikoresho by’ubuvuzi, bakirinda ibyago byo gukoresha ibikoresho by’ubuvuzi, kandi bagakusanya kandi bagatanga raporo ku gihe cy’ibikoresho by’ubuvuzi.