Pamene kufunikira kwa zipangizo zachipatala zapamwamba kwambiri zotayidwa kunja kukukulirakulira padziko lonse lapansi, mabungwe olamulira ku Europe ndi ku United States akulimbitsa zofunikira zotsatizana—makamaka ma syringe ndi zinthu zosonkhanitsira magazi. Zida zofunika kwambiri zachipatalazi zikufufuzidwa kwambiri chifukwa chogwiritsidwa ntchito kwambiri pozindikira matenda, kupereka katemera, ndi kusamalira odwala.
Kwa opanga, otumiza kunja, ndi ogulitsa, kumvetsetsa miyezo iyi yomwe ikusintha sikutanthauza kungokwaniritsa zofunikira zalamulo—ndikofunika kwambiri kuti zinthu zitetezeke, kupititsa patsogolo mwayi wopeza msika, komanso kumanga kudalirika kwa nthawi yayitali.
Kuyang'ana Kwambiri pa Chitetezo ndi Kutsata
Mu European Union ndi ku United States, chitetezo cha odwala ndicho chinthu chachikulu chomwe chimayambitsa kusintha kwa malamulo atsopano. Mwachitsanzo, lamulo la European Medical Device Regulation (MDR) la EU, lomwe linalowa m'malo mwa MDD yakale mu 2021, likugogomezera kuwunika kwathunthu kwachipatala, kuwunika zoopsa, ndi kuyang'anira pambuyo pa msika.
Ku US, FDA's 21 CFR Part 820 (Quality System Regulation) ikupitilizabe kukhala maziko a miyezo yopangira. Komabe, zosintha zomwe zikubwerazi zogwirizana ndi ISO 13485 zidzaika chidwi kwambiri pa kutsata ndi zolemba—makamaka zida za Gulu Lachiwiri monga ma syringe ndi machubu osonkhanitsira magazi.
Kodi izi zikutanthauza chiyani kwa ogulitsa? Gawo lililonse la unyolo wopereka zinthu—kuyambira kusankha zinthu zopangira mpaka kulongedza—liyenera kutsatiridwa ndi kutsimikiziridwa.
Kugogomezera pa Kugwirizana kwa Zamoyo ndi Kutsimikizika kwa Kusabereka
Popeza nkhawa ikukwera yokhudza momwe odwala amachitira komanso zoopsa zokhudzana ndi kuipitsidwa, kuyesa kuyanjana ndi zinthu zachilengedwe sikulinso kosankha. Oyang'anira aku Europe ndi US amafunikira mayeso ozama motsatira miyezo ya ISO 10993 kuti atsimikizire kuti zipangizo zomwe zimagwiritsidwa ntchito mu syringe, lancets, ndi machubu ndizotetezeka kukhudzana ndi anthu.
Kuphatikiza apo, njira zoyeretsera (monga ethylene oxide kapena gamma irradiation) ziyenera kukwaniritsa zofunikira zotsimikizika zomwe zafotokozedwa mu ISO 11135 kapena ISO 11137, motsatana. Kutsimikiza za sterility ndikofunikira kwambiri pazinthu zomwe zadzazidwa kale kapena kugwiritsidwa ntchito posonkhanitsa magazi mwachindunji.
Kwa ogula ndi otumiza mankhwala, izi zikutanthauza kuti kusankha ogulitsa omwe angapereke malipoti olembedwa okhudza kusabereka komanso njira zovomerezeka ndikofunikira kwambiri kuposa kale lonse.
Zipangizo Zosamalira Zachilengedwe ndi Zofunikira Zosungira Zinthu Zokhazikika
M'zaka zaposachedwapa, kukhazikika kwa zinthu kwasintha kuchoka pa uthenga wotsatsa kupita ku chiyembekezo cha malamulo. EU ikulimbikitsa kwambiri kuchepetsa mapulasitiki ogwiritsidwa ntchito kamodzi kokha ndi zinthu zowononga chilengedwe. Ngakhale kuti mankhwala nthawi zambiri saletsedwa, pali kukakamizidwa kwakukulu kogwiritsa ntchito zinthu zobwezerezedwanso kapena zopangidwa ndi zinthu zachilengedwe kulikonse komwe kungatheke.
Momwemonso, msika wa ku America—makamaka pakati pa maukonde akuluakulu ogula zinthu zachipatala—ukuchulukirachulukira kuwunika zinthu kutengera momwe zimakhudzira chilengedwe. Kuyika zinthu zomwe zimachepetsa zinyalala, kapena zipangizo zopangidwa kuchokera ku zipangizo zopanda BPA komanso zopanda DEHP, zikukhala zokonda kwambiri.
Kwa opanga zinthu zosonkhanitsira magazi ndi ma syringe, kusintha malinga ndi zomwe akuyembekezera sikungokwaniritsa zomwe akuyenera kutsatira komanso kumawonjezera mpikisano.
Kufunika kwa Kulemba Zolemba Molondola ndi Kutsatira UDI
Mabungwe olamulira akuletsa kulondola kwa zilembo. EU MDR ndi US FDA onse amafuna kuti zinthuzo zikhale ndi Unique Device Identifiers (UDI) yosindikizidwa bwino, masiku otha ntchito, manambala a batch, ndi malo a zilankhulo m'misika yomwe zimagulitsidwa.
Kulephera kukwaniritsa miyezo imeneyi kungayambitse kuchedwa kwa misonkho, kubweza katundu, kapena kutayika kwa mwayi wopeza msika. Kusankha njira yopakira ndi kulemba zilembo zomwe zimathandiza malamulo okhudza kulemba zilembo ndi gawo lofunika kwambiri pakuonetsetsa kuti ntchito zotumiza/kutumiza katundu kunja zikuyenda bwino.
Kuyenda ndi Malamulo Modzidalira
Kuyenda m'malo ovuta olamulira ku Europe ndi ku US kumafuna zambiri osati kungotsatira malamulo oyambira—kumafuna kukonzekera mwachangu, kutsimikizira zinthu nthawi zonse, komanso kusamala kwambiri za zomwe zikuchitika.
Kwa ogula, otumiza kunja, ndi opereka chithandizo chamankhwala, kukhala ndi chidziwitso cha malamulo aposachedwa a ma syringe ndi zinthu zosonkhanitsira magazi ndikofunikira popanga zisankho zanzeru pankhani yopeza mankhwala.
Mukufuna kuonetsetsa kuti mankhwala anu ogwiritsidwa ntchito ngati mankhwala otayidwa akwaniritsa miyezo yapadziko lonse lapansi? Lumikizanani ndi Sinomed lero kuti muwone momwe mayankho athu amathandizira kukwaniritsa zolinga zanu zovomerezeka komanso zabwino.
Nthawi yotumizira: Juni-23-2025
