Peb zoo siab tshaj tawm cov xov xwm loj uas, thaum Lub Kaum Ob Hlis Singclean Medical's absorbable hemostat khoom, nws cov Surgiclean absorbable hemostatic hais tau txais ntawv pov thawj los ntawm MDR (Medical Device Regulation). Qhov kev ua tiav tseem ceeb tshaj plaws no qhia tau hais tias lub tuam txhab ua tau zoo hauv kev kho mob thev naus laus zis tshiab thiab nthuav txoj hauv kev rau kev nthuav dav mus rau thoob ntiaj teb kev lag luam.
MDR yog tsab cai tshiab EU cov cuab yeej siv kho mob uas tau ua tiav hauv xyoo 2021. Nws tsim cov kev cai nruj dua ntawm kev nyab xeeb, kev ua haujlwm, thiab kev soj ntsuam ntawm cov cuab yeej kho mob. Tau txais MDR daim ntawv pov thawj tsis tsuas yog txhais tau hais tias cov khoom Surgiclean tau ntsib nrog cov kev cai lij choj EU tshiab, tab sis kuj qhia tau tias Singclean Medical txoj haujlwm tseem ceeb hauv kev tswj xyuas kev ua haujlwm zoo thiab kev tshawb fawb thiab kev tsim kho hauv kev kho mob.
Thaum lub sij hawm MDR daim ntawv pov thawj, Surgiclean absorbable hemostatic particles underwent nruj soj ntsuam validation, zoo system xyuas, thiab kev soj ntsuam cov ntaub ntawv. Lub koom haum tshuaj xyuas tau qhuas cov khoom lag luam kev nyab xeeb, kev ua tau zoo, thiab kev tsim kho tshiab.
Surgiclean absorbable hemostatic hais raws li cov ntaub ntawv tshiab hemostatic, muaj qhov zoo ntawm kev ua haujlwm zoo, nyab xeeb thiab siv tau yooj yim. Nws tuaj yeem nres los ntshav zoo li ntawm 3 feeb thiab haum rau ntau hom kev phais. Nws yog qhia nyob rau hauv phais raws li ib tug adjunctive hemostatic ntaus ntawv los pab thaum tswj ntawm capillary, venous, thiab arteriolar los ntshav los ntawm lub siab, ligature, thiab lwm cov pa txheej txheem yog ineffective los yog impractical. Nrog cov qauv microspheres, nws tuaj yeem nthuav dav nws thaj chaw kom nqus dej ntau hauv cov ntshav kom ua tiav cov txiaj ntsig zoo los ntshav. Cov ntaub ntawv cog qoob loo tuaj yeem ua rau nws ntau biodegradable thiab nyab xeeb!
Nyem kom paub Absorbable Hemostatic Powder
Tau txais daim ntawv pov thawj ntawm MDR, txhais tau tias Surgiclean absorbable hemostatic particles underwent kev soj ntsuam nruj validation, zoo system tshuaj xyuas thiab kev soj ntsuam cov ntaub ntawv, thiab tuaj yeem nkag mus rau EU kev lag luam.
Nws txhais tau hais tias Surgiclean kev sib raug zoo hauv kev lag luam thoob ntiaj teb txhim kho ntau, nteg lub hauv paus ruaj khov rau Singclean Medical nkag mus rau EU thiab lwm lub lag luam thoob ntiaj teb. Nyob rau hauv lub neej yav tom ntej, Singclean kev kho mob yuav tshawb xyuas cov kev siv peev xwm ntawm kev hnav khaub ncaws hemostatic thiab nrhiav kev daws teeb meem tshiab rau kev phais.