Nkhani

Njira zitatu zopezera zochitika zoyipa za chipangizo chachipatala

Malo osungira, dzina lazinthu ndi dzina la wopanga ndi njira zitatu zazikulu zowunikira zochitika zoyipa za zida zachipatala.

Kubwezanso kwa zochitika zoyipa za chipangizo chachipatala zitha kuchitidwa motsata nkhokwe, ndipo ma database osiyanasiyana ali ndi mawonekedwe awo.Mwachitsanzo, uthenga wokhudzana ndi zovuta za chipangizo chachipatala cha ku China umakhala wodziwikiratu zovuta zamtundu wina wazinthu, pomwe zovuta zomwe zidalembedwa pazidziwitso za chipangizo chachipatala zimachokera ku United States, United Kingdom, Australia ndi Canada Medical device. chenjezo kapena kukumbukira deta yakunyumba ndi dera sizomwe zanenedwa kunyumba;MAUDE database yaku United States ndi nkhokwe yathunthu, bola ngati zochitika zoyipa za zida zamankhwala zomwe zanenedwa molingana ndi malamulo a FDA ku United States zidzalowetsedwa munkhokwe;zida zachipatala zovuta / kukumbukira / zidziwitso zokhudzana ndi zidziwitso zamayiko ndi zigawo monga United Kingdom, Canada, Australia ndi Germany zizisinthidwa pafupipafupi.Kuti mutengenso zochitika zoyipa za chipangizo chachipatala molunjika ku database, zitha kuwonedwa molingana ndi mawu osakira, komanso zitha kubwezedwanso molondola pochepetsa nthawi kapena malo achinsinsi.

Kuti mutengerenso zochitika zachipatala motsata dzina lachidziwitso, mutha kuyika dzina lachidakwa chachipatala chomwe mukuyembekezera patsamba lobweza kuti mutengenso, ndipo nthawi zambiri simuyenera kuyika dzina lachindunji.

Mukasaka molingana ndi dzina labizinesi yazida zamankhwala, ngati bizinesiyo ndi bizinesi yolipidwa ndi mayiko ena, ndikofunikira kulabadira mawonekedwe osiyanasiyana abizinesi, monga mlandu, chidule, ndi zina zambiri.

Kusanthula kwa zochitika zoyipa kubweza kuchokera kuzochitika zinazake

Zomwe zili mu lipoti la kafukufuku wowunika zomwe zidachitika pazida zachipatala zingaphatikizepo chidule chachidule cha cholinga chowunika ndi kuwunika momwe zida zachipatala zilili;kuyang'anira magwero a deta;nthawi yanthawi yobwezeretsa zochitika zoyipa;kuchuluka kwa zochitika zoyipa;gwero la malipoti;ziwopsezo za zochitika zoyipa;zotsatira za zochitika zoipa;kuchuluka kwa zovuta zosiyanasiyana;njira zomwe zimatengedwa pazinthu zoyipa;ndi;Dongosolo lowunikira komanso kuwunikira litha kupereka chilimbikitso pakuwunikiridwa kwaukadaulo, kuyang'anira malonda pambuyo pa malonda, kapena kuyang'anira zoopsa zamabizinesi opanga.

Poganizira kuchuluka kwa zidziwitso, zidziwitso 219 zidabwezedwa pochepetsa "productcode" mpaka June 2019. Pambuyo pochotsa zidutswa 19 zazomwe sizinali zoyipa, zidutswa 200 zotsala zidaphatikizidwa pakuwunika.Zambiri zomwe zili m'dawunilodi zimachotsedwa m'modzim'modzi, pogwiritsa ntchito pulogalamu ya Microsoft Excel yomwe idasonkhanitsidwa kuchokera komwe lipotilo, zidziwitso zokhudzana ndi zida zamankhwala (kuphatikiza dzina la wopanga, dzina lazogulitsa, mtundu wa chipangizo chachipatala, zovuta za chipangizo chachipatala) , nthawi ya zochitika zowopsya, nthawi yomwe FDA idalandira zochitika zotsutsana, mtundu wa zochitika zovuta, zomwe zimayambitsa zochitika zovuta, ndiyeno kusanthula malo a zochitika zovuta Zomwe zimayambitsa zochitika zowonongeka zinafotokozedwa mwachidule, ndipo njira zowongolera zinali zomveka. kuika patsogolo ku mbali za ntchito, prosthesis mapangidwe ndi unamwino pambuyo opaleshoni.Njira yowunikira yomwe ili pamwambapa ndi zomwe zili pamwambazi zitha kugwiritsidwa ntchito ngati zowunikira pakuwunika zochitika zoyipa za chipangizo chachipatala chofananira.

Kusanthula kwa zochitika zoyipa kuti muwonjezere kuwongolera zoopsa

Chidule ndi kusanthula kwa zochitika zoyipa za zida zachipatala zili ndi tanthauzo linalake pamadipatimenti owongolera zida zachipatala, mabizinesi opanga ndi kugwiritsa ntchito ndi ogwiritsa ntchito kuti aziwongolera zoopsa.Kwa dipatimenti yoyang'anira, kupanga ndi kukonzanso malamulo a zida zachipatala, malamulo ndi zikalata zovomerezeka zitha kuchitidwa limodzi ndi kuwunika kwa zochitika zoyipa, kuti kuwongolera kuwopsa ndi kasamalidwe ka zida zamankhwala kukhala ndi malamulo ndi malamulo oti azitsatira. .Limbikitsani kuyang'anira positi pazida zamankhwala, kusonkhanitsa ndi kufotokoza mwachidule zochitika zoyipa, kuchenjeza ndi kukumbukira zambiri zazida zamankhwala pafupipafupi, ndikutulutsa chilengezocho munthawi yake.Panthawi imodzimodziyo, limbitsani kuyang'anira kwa opanga zipangizo zachipatala, kulinganiza njira zawo zopangira, ndi kuchepetsa bwino mwayi wa zochitika zovuta kuchokera ku gwero.Kuonjezera apo, tiyenera kupitiriza kulimbikitsa kafukufuku wa sayansi wokhudza kuyang'anira zipangizo zachipatala ndikupanga ndondomeko yowunika kutengera kuopsa kwa ngozi.

Mabungwe azachipatala akuyenera kulimbikitsa maphunziro ndi kasamalidwe, kuti asing'anga azitha kudziwa bwino momwe angagwiritsire ntchito zida ndi luso la kagwiritsidwe ntchito ka zida, ndikuchepetsa mwayi wa zochitika zoyipa.Kulimbikitsanso kuphatikiza kwa zamankhwala ndi uinjiniya, ndikulimbikitsa azachipatala kuti azilumikizana ndi akatswiri opanga zida zamankhwala pamavuto omwe amapezeka pakugwiritsa ntchito kwachipatala kwa zida zamankhwala, kuti asing'anga athe kumvetsetsa bwino zida zamankhwala zomwe zimagwiritsidwa ntchito, komanso kuthandizira. akatswiri opanga zida zamankhwala kuti apange bwino kapena kukonza zida zachipatala.Kuonjezera apo, chitsogozo cha kukonzanso kwachipatala chiyenera kulimbikitsidwa kuti akumbutse odwala mfundo zazikuluzikulu kuti ateteze kulephera msanga kwa implants chifukwa cha ntchito zosayembekezereka kapena ntchito yosayenera.Panthawi imodzimodziyo, madokotala akuyenera kudziwitsa anthu za zinthu zoipa zimene zingachitike pa chipangizo chachipatala, kupewa kuopsa kwa kugwiritsa ntchito zida zachipatala, komanso kusonkhanitsa ndi kupereka lipoti pazida zomwe zachitika.