Njengoko imfuno yehlabathi jikelele yezixhobo zonyango ezilahlwayo ezisemgangathweni iqhubeka ikhula, imibutho elawulayo eYurophu nase-United States iyaqinisa iimfuno zokuthobela imithetho—ingakumbi kwiisirinji kunye nezinto ezisetyenziswayo zokuqokelela igazi. Ezi zixhobo zonyango zibalulekileyo ziphantsi koqwalaselo olukhulu ngenxa yokusetyenziswa kwazo ngokubanzi ekuxilongeni, ekugonyeni, nasekunyamekeleni izigulana.
Kubavelisi, abangenisa impahla kwamanye amazwe, kunye nabasasazi, ukuqonda le migangatho itshintshayo akupheleli nje ekuhlangabezaneni neemfuno zomthetho—kubalulekile ekuqinisekiseni ukhuseleko lwemveliso, ukuphucula ukufikelela kwimarike, kunye nokwakha ukuthembeka kwexesha elide.
Ukugxila Okungqongqo Kukhuseleko Nokulandelelana
Kwi-European Union nase-United States, ukhuseleko lwezigulane yeyona nto iphambili ebangela utshintsho olutsha kulawulo. Umzekelo, i-EU's Medical Device Regulation (MDR), eyathatha indawo ye-MDD yangaphambili ngo-2021, igxininisa uvavanyo olupheleleyo lweklinikhi, uvavanyo lomngcipheko, kunye nokubeka esweni emva kwemarike.
E-US, i-FDA's 21 CFR Part 820 (Quality System Regulation) iyaqhubeka nokusebenza njengesiseko semigangatho yokuvelisa. Nangona kunjalo, uhlaziyo oluzayo oluhambelana ne-ISO 13485 luya kubeka ingqwalasela enkulu ekulandeleni nasekubhaleni amaxwebhu—ingakumbi kwizixhobo zeKlasi yesiBini ezifana neesirinji kunye neetyhubhu zokuqokelela igazi.
Kuthetha ukuthini oku kubaboneleli? Lonke inqanaba lenkqubo yokubonelela—ukusuka ekukhethweni kwezinto eziluhlaza ukuya ekupakishweni—ngoku kufuneka lilandeleke kwaye liqinisekiswe.
Ugxininiso kwi-Biocompatibility kunye ne-Stality Assurance
Ngenxa yokwanda kwenkxalabo malunga nokusabela kwezigulane kunye neengozi zongcoliseko, uvavanyo lokuhambelana kwezinto eziphilayo alusekho ukhetho. Abalawuli baseYurophu naseMelika bafuna uvavanyo olunzulu phantsi kwemigangatho ye-ISO 10993 ukuqinisekisa ukuba izixhobo ezisetyenziswa kwiisirinji, ii-lancets, kunye neetyhubhu zikhuselekile ekunxibelelaneni nabantu.
Ukongeza, iinkqubo zokubulala iintsholongwane (ezifana ne-ethylene oxide okanye i-gamma irradiation) kufuneka zihlangabezane neemfuno zokuqinisekiswa ezichazwe kwi-ISO 11135 okanye kwi-ISO 11137, ngokwahlukeneyo. Ukuqinisekiswa kokubulala iintsholongwane kubaluleke kakhulu kwiimveliso ezizalisiweyo okanye ezisetyenziswa ekuqokeleleni igazi ngokuthe ngqo.
Kubathengi bezonyango kunye nabangenisi, oku kuthetha ukuba ukukhetha ababoneleli abanokubonelela ngeengxelo zokuzala ezibhaliweyo kunye neenkqubo eziqinisekisiweyo kubaluleke kakhulu kunangaphambili.
Izixhobo Ezikhathalela Indalo kunye Neemfuno Zokupakisha Ezizinzileyo
Kwiminyaka yakutshanje, uzinzo luye lwasuka ekubeni ngumyalezo wokuthengisa lwaya kulindelo olusemthethweni. I-EU ikhuthaza ngokukhutheleyo ukuncitshiswa kweeplastiki ezisetyenziswa kanye kunye nezinto ezinobungozi kokusingqongileyo. Nangona iimveliso zonyango zihlala zingathintelwanga, kukho uxinzelelo olukhulayo lokusebenzisa izinto ezinokuphinda zisetyenziswe okanye ezisekelwe kwi-bio naphi na apho kunokwenzeka khona.
Ngokufanayo, imakethi yaseMelika—ingakumbi phakathi kwenethiwekhi ezinkulu zokuthengwa kweenkonzo zempilo—iya ivavanya iimveliso ngokusekwe kumlinganiselo wazo wokusingqongileyo. Ukupakisha okunciphisa inkunkuma, okanye izixhobo ezenziwe ngezinto ezingenayo i-BPA kunye ne-DEHP, kuya kuba yinto eqhelekileyo.
Kubavelisi bezinto zokuqokelela igazi kunye neesirinji, ukuziqhelanisa nezi zinto zilindelweyo akuyi kuhlangabezana nokuthobela imithetho kuphela—kodwa kuya kuphucula ukukhuphisana.
Ukubaluleka kokubhala iilebheli ngokuchanekileyo kunye nokuthobela i-UDI
Imibutho elawulayo iyawucinezela umkhwa wokuchaneka kweelebhile. I-EU MDR kunye ne-US FDA zombini zifuna ukuba iimveliso zibe ne-Unique Device Identifiers (UDI) eprintiweyo ngokucacileyo, imihla yokuphelelwa, iinombolo zebhetshi, kunye nolwimi olusetyenziswa kwiimarike apho zithengiswa khona.
Ukungaphumeleli ukuhlangabezana nale migangatho kunokubangela ukulibaziseka kwempahla ethengiswayo, ukubizwa kwakhona, okanye ukulahleka kokufikelela kwimarike. Ukukhetha inkqubo yokupakisha kunye nokubhala iilebhile exhasa iimfuno zomthetho zokulebhile linyathelo elibalulekileyo ekuqinisekiseni imisebenzi yokungenisa/yokuthumela ngaphandle egudileyo.
Ukuhamba ngeMigqaliselo ngokuzithemba
Ukuhambahamba kwimeko-bume enzima yokulawula eYurophu nase-US kufuna okungaphezulu nje kokuthobela imithetho esisiseko—kufuna ukulungiswa kwangaphambili, ukuqinisekiswa kwemveliso okuqhubekayo, kunye nokuqwalasela ngokusondeleyo iindlela ezintsha.
Kubathengi, abangenisa impahla kwamanye amazwe, kunye nababoneleli beenkonzo zonyango ngokufanayo, ukuhlala unolwazi malunga nemithetho yamva nje kwiisirinji kunye nezinto ezisetyenziswayo zokuqokelelwa kwegazi kubalulekile ekwenzeni izigqibo zokufumana igazi ngobuchule.
Ngaba ujonge ukuqinisekisa ukuba iimveliso zakho zonyango ezilahlwayo ziyahlangabezana nemigangatho yemithetho yehlabathi? Nxibelelana neSinomed namhlanje kwaye uhlole indlela izisombululo zethu ezixhasa ngayo ukuthobela kwakho kunye neenjongo zakho zomgangatho.
Ixesha leposi: Juni-23-2025
