Intshayelelo
Kwicandelo lezempilo, ukubaluleka kwezixhobo zentsholongwane akunakuba ngaphezulu. Xa kufikwa kwiseti yokuhlisela, ukuqinisekisa ukuchuma kwabo kubalulekile ukuthintela umngcipheko wokosuleleka kunye nobunzima. Kweli nqaku, siza kuthobela kwihlabathi lemveliso ezenzekelayo yokuphangwa kwentembeko yokuphembelela, ngokukodwa ezo zifumene iziqinisekiso ze-FDA kunye ne-CE, ziqinisekisa umgangatho wabo kunye nokhuseleko.
Kukuthini ukumiswa kwembeko?
Ukubekwa kwembeko, okwabizwa ngokuba yi-IV ukungcola, sisixhobo sezonyango esisetyenziselwa ukuhambisa amanzi, amayeza, okanye izakha-mzimba ngqo kwigazi legazi lesigulana. Inamacandelo ahlukeneyo, kubandakanya igumbi ledriphi, ityhubhu, inaliti okanye i-catheter. Eyona njongo iphambili yokunikezelwa kwembeko kukuqinisekisa ukuhamba okulawulwayo kunye nokulawulwa kweembiza, ukugcina impilo-ntle yempilo kunye nempilo.
Ukubaluleka kokungasebenzi
Xa kufikwa kwizixhobo zonyango, ukuchuma kubaluleke kakhulu. Nakuphi na ungcoliseko okanye ubukho bezilimano zinokukhokelela kusulelo olukhulu, zibeka ubomi bomguli. Ke ngoko, iiseti zemveliso yokuthakathisikelwa kwimo yemo yemodeli ibalulekile. Kulapho imveliso ezenzekelayo idlala indima ebalulekileyo.
Ukuveliswa kwemveliso ezenzekelayo yeseti ye-sterile
Inkqubo yokuvelisa ezenzekelayo yokufaka i-Sterile Susion ibandakanya uthotho lweetekhnoloji eziphambili kunye namanyathelo olawulo olusemgangathweni. Iqala ngokukhethwa kwezinto ezikumgangatho ophezulu, ezifana nePlastiki yebanga lezonyango, iqinisekisa ukhuseleko kunye nokuhambelana kwemveliso yokugqibela.
Inkqubo yokwenziwa yenzeka kwindawo ecocekileyo, eyenzelwe ukugcina imeko elawulwayo ayinamsebenzi. Oomatshini abazenzekelayo basetyenziselwa ukudibanisa izinto ezahlukeneyo zokuthakathi kwembeko, ukunciphisa umngcipheko wempazamo yomntu kunye nokuqinisekisa ukuba umgangatho ofanayo.
Yonke imbonakalo yemveliso inxulunyaniswa ngokusondeleyo kwaye ilawulwa, inamathela kwiZikhokelo ezingqongqo ezisetwa ngemizimba yolawulo njenge-FDA no-CE. Esi siqinisekiso sokuba i-incophotion ye-insulion idibana nemigangatho ephezulu yokhuseleko kunye nokusebenza kakuhle.
I-FDA kunye neCETES
Ukuqhubela phambili kuqiniseko ngomgangatho kunye nokukhuseleka kweeseti zokuhlisela, i-FDA kunye nezatimetshi ze-CE zifunyenwe. Isatifikethi se-FDA sibonisa ukuba imveliso yenziwa uvavanyo kunye nohlalutyo, oluthobela imigaqo ebekiweyo kulawulo lwe-US kunye nolawulo lweziyobisi. Kwelinye icala, isiqinisekiso se-CE sibonisa ukuba imveliso ihlangabezana nempilo ye-European Union, ukhuseleko, kunye nemigangatho yokhuseleko lokusingqongileyo.
Ukuqukumbela
Ukuqukumbela, ukuveliswa okuzenzekelayo kweseti yokunikezelwa kwengqokelela yinkqubela phambili yotshintsho kwicandelo lezempilo. Ngokusebenzisa itekhnoloji yolawulo oluphezulu kunye nokubambelela kumanyathelo olawulo olungqongqo ngokungqongqo, ezi ndawo zemveliso ezenzekelayo ziqinisekisa ukungathobeli, ukhuseleko, kunye nokusebenza ngokusebenza kweseti yokunikwa kwembeko. I-FDA kunye neCETEEST iqinisekisile umgangatho wabo, ukubonelela ngoochwephesha bezempilo kunye nezigulana ngoxolo lwengqondo. Ngezi nkqubo zemveliso ezenzekelayo, ikamva lokuncipha konyango libonakala liqaqambe ngakumbi kunangaphambili, elithembisa i-IV ekhuselekileyo nenempumelelo.