Amakuru

Inzira eshatu zo kugarura ingaruka mbi ku bikoresho by'ubuvuzi

Ububiko bw'amakuru, izina ry'umusaruro n'izina ry'uwakoze ni byo byerekezo bitatu by'ingenzi byo kugenzura ingaruka mbi ku bikoresho by'ubuvuzi.

Gushakisha ingaruka mbi ku bikoresho by’ubuvuzi bishobora gukorwa mu cyerekezo cy’ububiko bw’amakuru, kandi ububiko butandukanye bufite imiterere yabwo. Urugero, amakuru ajyanye n’ingaruka mbi ku bikoresho by’ubuvuzi mu Bushinwa ahora amenyesha ingaruka mbi ku bwoko runaka bw’ibicuruzwa, mu gihe ingaruka mbi ku bikoresho by’ubuvuzi bivugwa mu cyerekezo cy’ubwirinzi bw’ibikoresho by’ubuvuzi ahanini bituruka muri Leta Zunze Ubumwe za Amerika, Ubwongereza, Ositaraliya na Kanada. Amakuru ajyanye n’ubwirinzi bw’ibikoresho by’ubuvuzi cyangwa kwibutsa ibyavuye mu rugo no mu karere atari amakuru atangwa mu gihugu; ububiko bw’amakuru bwa MAUDE bwa Leta Zunze Ubumwe za Amerika ni ububiko bwuzuye, igihe cyose ingaruka mbi ku bikoresho by’ubuvuzi zitanzwe hakurikijwe amabwiriza ya FDA ya Leta Zunze Ubumwe za Amerika zizinjiye muri ububiko bw’amakuru; amakuru ajyanye n’ingaruka mbi ku bikoresho by’ubuvuzi / kwibutsa / kwibutsa ibyavuye mu bikoresho by’ubuvuzi mu cyerekezo cy’ububiko bw’amakuru bw’ibihugu n’uturere nk’Ubwongereza, Kanada, Ositaraliya n’Ubudage azavugururwa buri gihe. Kugira ngo haboneke ingaruka mbi ku bikoresho by’ubuvuzi mu cyerekezo cy’ububiko bw’amakuru, bishobora gusuzumwa hakurikijwe amagambo y’ingenzi, kandi bishobora no kuboneka neza hakoreshejwe igihe gito cyangwa aho amagambo y’ingenzi aherereye.

Kugira ngo ukore ubushakashatsi ku byago byatewe n’ibikoresho by’ubuvuzi mu cyerekezo cy’izina ry’ibicuruzwa, ushobora kwandika izina ry’ibicuruzwa by’ibikoresho by’ubuvuzi ku ipaji yo kubikuramo amakuru kugira ngo ubikuremo, kandi muri rusange ntugomba kwandika izina ry’ibicuruzwa runaka.

Mu gushakisha ukurikije izina ry'ikigo gishinzwe ibikoresho by'ubuvuzi, niba ikigo ari ikigo giterwa inkunga n'amahanga, ni ngombwa kwita ku buryo butandukanye izina ry'ikigo rigaragara, nk'inyuguti, incamake, n'ibindi.

Isesengura ry'ibyavuye mu manza runaka byagaragaye mu buryo bubi

Ibikubiye muri raporo y'ubushakashatsi ku birebana n'ingaruka mbi ku bikoresho by'ubuvuzi bishobora kuba birimo ariko bitagarukira gusa ku incamake ngufi y'intego yo gukurikirana n'igenzura ry'ingaruka mbi ku bikoresho by'ubuvuzi; inkomoko y'amakuru akurikirana; igihe cyo kugarura ingaruka mbi; umubare w'ingaruka mbi; inkomoko ya raporo; impamvu z'ingaruka mbi; ingaruka z'ingaruka mbi; igipimo cy'ingaruka mbi zitandukanye; ingamba zafashwe ku ngaruka mbi; na; Amakuru akurikirana n'uburyo bwo gukurikirana bishobora gutanga imbaraga zo gusuzuma tekiniki, kugenzura ibicuruzwa nyuma yo kwamamaza, cyangwa gucunga ingaruka z'ibigo bikora.

Bitewe n’ubwinshi bw’amakuru, amakuru 219 yakusanyijwe binyuze mu kugabanya "productcode" kugeza muri Kamena 2019. Nyuma yo gusiba amakuru 19 atari ay’impanuka, andi 200 asigaye yashyizwe mu isesengura. Amakuru ari muri database akurwamo rimwe ku rindi, hakoreshejwe porogaramu ya Microsoft Excel yakusanyijwe mu isoko ya raporo, amakuru ajyanye n’ibikoresho by’ubuvuzi (harimo izina ry’uwakoze, izina ry’umusaruro, ubwoko bw’igikoresho cy’ubuvuzi, ibibazo by’ibikoresho by’ubuvuzi), igihe ibintu bibi byabereye, igihe FDA yakiriye ibintu bibi, ubwoko bw’ibintu bibi, impamvu z’ibintu bibi, hanyuma igasesengura aho ibintu bibi byabereye. Impamvu nyamukuru z’ibintu bibi zavuzwe muri make, kandi ingamba zo kunoza zashyizwe ahagaragara uhereye ku mikorere, imiterere y’inzobere n’ubuforomo nyuma yo kubagwa. Isesengura ryavuzwe haruguru n’ibikubiye muri iryo sesengura bishobora gukoreshwa nk’icyitegererezo mu isesengura ry’ibintu bibi nk’ibyo by’ibikoresho by’ubuvuzi.

Isesengura ry'ingaruka mbi kugira ngo hongerwe urwego rwo kugenzura ingaruka

Incamake n'isesengura ry'ingaruka mbi ku bikoresho by'ubuvuzi bifite akamaro gakomeye ku mashami ashinzwe kugenzura ibikoresho by'ubuvuzi, ibigo bikora n'ibikoresha ndetse n'abakoresha kugira ngo bakore igenzura ry'ingaruka mbi. Ku rwego rushinzwe kugenzura, gushyiraho no kuvugurura amabwiriza agenga ibikoresho by'ubuvuzi, amategeko n'inyandiko zigenga bishobora gukorwa hamwe n'ibyavuye mu isesengura ry'ingaruka mbi, kugira ngo igenzura n'imicungire y'ibikoresho by'ubuvuzi bibe bifite amategeko n'amabwiriza agomba gukurikiza. Kongera imbaraga mu kugenzura nyuma yo kwamamaza ibikoresho by'ubuvuzi, gukusanya no gushyira mu ncamake ingaruka mbi, kuburira no kwibuka amakuru y'ibikoresho by'ubuvuzi buri gihe, no gutangaza itangazo ku gihe. Muri icyo gihe, kongerera imbaraga igenzura ry'abakora ibikoresho by'ubuvuzi, gushyiraho uburyo bwo kubitunganya, no kugabanya neza ibyago by'ingaruka mbi bivuye aho byaturutse. Byongeye kandi, tugomba gukomeza guteza imbere ubushakashatsi bwa siyansi ku igenzura ry'ibikoresho by'ubuvuzi no kubaka uburyo bwo gusuzuma bushingiye ku igenzura ry'ingaruka nyazo.

Ibigo by'ubuvuzi bigomba kongera amahugurwa n'imicungire, kugira ngo abaganga bashobore kumenya ibisabwa mu mikorere n'ubuhanga mu mikorere y'ibikoresho, kandi bagabanye ibyago byo guhura n'ingaruka mbi. Kugira ngo hakorwe imbaraga mu guhuza ubuvuzi n'ubwubatsi, no gusaba abaganga kuvugana n'abahanga mu gushushanya ibikoresho by'ubuvuzi ku bibazo biboneka mu ikoreshwa ry'ibikoresho by'ubuvuzi, kugira ngo abaganga barusheho gusobanukirwa neza ibikoresho by'ubuvuzi bikoreshwa, kandi banafashe abahanga mu gushushanya ibikoresho by'ubuvuzi kunoza imiterere cyangwa kunoza ibikoresho by'ubuvuzi. Byongeye kandi, amabwiriza yo kuvugurura imikorere y'ubuvuzi agomba gushimangirwa kugira ngo yibutse abarwayi ingingo z'ingenzi zo kwirinda ko implants zangirika vuba bitewe n'ibikorwa bidakwiye cyangwa imikorere mibi. Muri icyo gihe, abaganga bagomba kunoza ubumenyi bwabo ku ngaruka mbi z'ibikoresho by'ubuvuzi, birinda ibyago byo gukoresha ibikoresho by'ubuvuzi, kandi bagakusanya kandi bagatanga raporo ku gihe ku ngaruka mbi z'ibikoresho by'ubuvuzi.