Pamene kufunika kwapadziko lonse kwa zipangizo zamakono zotayidwa kukupitiriza kukula, mabungwe olamulira ku Ulaya ndi United States akulimbikitsanso kuti anthu azitsatira, makamaka ma syringe ndi zinthu zotengera magazi. Zida zofunika zachipatalazi zikuwunikidwa mochulukirachulukira chifukwa chofala kwambiri pakuzindikira matenda, katemera, komanso chisamaliro cha odwala.
Kwa opanga, ogulitsa kunja, ndi ogulitsa, kumvetsetsa mfundo zomwe zikupita patsogolo sikungokwaniritsa zofunikira zamalamulo - ndikofunikira kuwonetsetsa kuti zinthu zili zotetezeka, kupititsa patsogolo kupezeka kwa msika, komanso kudalirika kwanthawi yayitali.
Kuyikira Kwambiri Pachitetezo ndi Kutsata
M'mayiko onse a European Union ndi United States, chitetezo cha odwala ndichomwe chimayambitsa kusintha kwatsopano kwa malamulo. Mwachitsanzo, EU's Medical Device Regulation (MDR), yomwe idalowa m'malo mwa MDD yapitayi mu 2021, ikugogomezera kuunika kwazachipatala, kuwunika kwachiwopsezo, ndikuwunika pambuyo pa msika.
Ku US, FDA's 21 CFR Part 820 (Quality System Regulation) ikupitilizabe kukhala maziko amiyezo yopangira. Komabe, zosintha zomwe zikubwera zomwe zikugwirizana ndi ISO 13485 zidzaika chidwi kwambiri pa kufufuza ndi zolemba, makamaka pazida za Gulu II monga ma syringe ndi machubu otolera magazi.
Kodi izi zikutanthauza chiyani kwa ogulitsa? Gawo lirilonse la njira zogulitsira - kuchokera pa kusankha kwa zinthu mpaka pakuyika - liyenera kutsatiridwa ndi kutsimikizika.
Kugogomezera pa Biocompatibility ndi Sterility Assurance
Ndi nkhawa zomwe zikuchulukirachulukira za momwe odwala angatengere komanso kuwopsa kwa matenda, kuyesa kwa biocompatibility sikulinso kosankha. Oyang'anira ku Europe ndi ku US amafunikira kuyesedwa mozama pansi pamiyezo ya ISO 10993 kuti atsimikizire kuti zida zomwe zimagwiritsidwa ntchito mu syringe, ma lancets, ndi machubu ndizotetezeka kuti anthu angakumane nazo.
Kuphatikiza apo, njira zoletsera (monga ethylene oxide kapena gamma irradiation) ziyenera kukwaniritsa zofunikira zomwe zafotokozedwa mu ISO 11135 kapena ISO 11137 motsatana. Chitsimikizo cha sterility ndi chofunikira kwambiri pazinthu zomwe zimadzazidwa kapena kugwiritsidwa ntchito posonkhanitsa magazi mwachindunji.
Kwa ogula azachipatala ndi ogulitsa kunja, izi zikutanthauza kusankha ogulitsa omwe angapereke malipoti ovomerezeka ndi njira zovomerezeka ndizofunikira kwambiri kuposa kale.
Eco-Conscious Materials ndi Zofunikira Pakuyika Zokhazikika
M'zaka zaposachedwa, kukhazikika kwachoka ku uthenga wamalonda kupita ku chiyembekezo chowongolera. EU ikulimbikitsa kwambiri kuchepetsedwa kwa mapulasitiki ogwiritsidwa ntchito kamodzi ndi zinthu zowononga chilengedwe. Ngakhale kuti mankhwala azachipatala nthawi zambiri saloledwa kuletsa, pali chikakamizo chokulirapo chogwiritsa ntchito zinthu zobwezerezedwanso kapena zochokera pazachilengedwe ngati kuli kotheka.
Momwemonso, msika waku US-makamaka pakati pamagulu akuluakulu ogulira chithandizo chamankhwala-ukuwunikanso zinthu zambiri potengera chilengedwe. Kupaka komwe kumachepetsa zinyalala, kapena zida zopangidwa kuchokera ku zida za BPA-free ndi DEHP, zikukhala zokonda.
Kwa opanga zinthu zogulira magazi ndi ma syringe, kusintha mogwirizana ndi zoyembekeza izi sikungokwaniritsa kutsatiridwa - komanso kumawonjezera kupikisana.
Kufunika Kolemba Zolondola ndi Kutsata UDI
Mabungwe owongolera akuphwanya kulondola kwa zilembo. EU MDR ndi US FDA onse amafuna kuti zinthu zizisindikizidwa momveka bwino, Unique Device Identifiers (UDI), masiku otha ntchito, manambala a batch, ndi chilankhulo cha misika yomwe amagulitsidwa.
Kulephera kukwaniritsa miyezo imeneyi kungayambitse kuchedwa kwa kasitomu, kukumbukira kukumbukira, kapena kutayika kwa msika. Kusankha kakhazikitsidwe ndi kulemba zilembo zomwe zimathandizira zofunikira zamalembo ndi gawo lofunikira pakuwonetsetsa kuti ntchito zotumiza kapena kutumiza kunja zikuyenda bwino.
Kuyendera Malamulo Ndi Chidaliro
Kuyenda m'malo ovuta kuwongolera ku Europe ndi US kumafuna zambiri osati kungotsatira - kumafunikira kukonzekera mwachangu, kutsimikizira kwazinthu zomwe zikuchitika, komanso kusamala kwambiri zomwe zikuchitika.
Kwa ogula, ogulitsa kunja, ndi opereka chithandizo chamankhwala chimodzimodzi, kudziwa malamulo aposachedwa a majakisoni ndi zinthu zotengera magazi ndikofunikira kuti mupange zisankho mwanzeru.
Mukuyang'ana kuwonetsetsa kuti mankhwala anu azachipatala omwe angathe kutayidwa akukwaniritsa miyezo yapadziko lonse lapansi? Lumikizanani ndi Sinomed lero ndikuwona momwe mayankho athu amathandizira kutsatira kwanu komanso zolinga zabwino.
Nthawi yotumiza: Jun-23-2025
