Kupha tizilombo toyambitsa matenda m'zida zamankhwala kumathandiza kwambiri kuti odwala atetezeke komanso kupewa kufalikira kwa matenda.

Mayiko osiyanasiyana ndi mafakitale azaumoyo akhazikitsa zofunikira ndi malamulo okhudzana ndi kupha tizilombo toyambitsa matenda opumira.Nkhaniyi ikufuna kufufuza malangizo ndi miyezo yokhazikitsidwa ndi mayiko osiyanasiyana, kuyang'ana ku China ndi mayiko ena otukuka.Pomvetsetsa malamulowa, akatswiri azachipatala amatha kuwonetsetsa kuti ma ma ventilator opumira amatha kupha tizilombo toyambitsa matenda ndikusunga chisamaliro chapamwamba cha odwala.

1. Zofunikira Zophera tizilombo ku China

Ku China, zofunikira zophera tizilombo toyambitsa matenda opumira zimayendetsedwa ndi National Health Commission (NHC) ndi State Administration for Market Regulation (SAMR)."Malangizo opha tizilombo toyambitsa matenda m'makonzedwe azaumoyo" operekedwa ndi NHC amapereka malangizo atsatanetsatane opha tizilombo toyambitsa matenda, kuphatikizapo opumira.Malinga ndi malangizowa, njira yopha tizilombo toyambitsa matenda ikuyenera kutsatira mfundo zokhuza kusamalitsa, kuchita bwino, komanso chitetezo.Maupangiri amatchulanso mankhwala ophera tizilombo omwe akulimbikitsidwa, nthawi yowonekera, komanso mpweya wabwino panthawi yakupha.

Kuphatikiza apo, SAMR imayang'anira kukhazikitsidwa kwa miyezo monga "Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes" (YY/T 0287) ndi "Medical Devices - Application of Risk Management to Medical Devices" (YY/T 0466.1 ).Miyezo iyi imawonetsetsa kuti zida zopumira zimakwaniritsa zofunikira ndipo zimatetezedwa bwino ndi tizilombo tisanagwiritse ntchito.

2. Zofunikira ku United States

Ku United States, Food and Drug Administration (FDA) imapereka chitsogozo ndi malamulo opha tizilombo toyambitsa matenda opumira.Malinga ndi FDA's "Guidance for Industry and FDA Staff - Processing Medical Devices in Health Care Settings: Validation Njira ndi Kulemba," ma ventilator opumira ayenera kuchitidwanso njira yovomerezeka kuti awonetsetse kuti ali otetezeka komanso ogwira mtima.

Kuphatikiza apo, Association for the Advancement of Medical Instrumentation (AAMI) imasindikiza miyezo monga "ANSI/AAMI ST79:2017 - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities."Muyezowu ukufotokoza njira zabwino kwambiri zophera tizilombo toyambitsa matenda ndi kutsekereza zida zachipatala, kuphatikiza zopumira, kuteteza matenda okhudzana ndi zaumoyo.

3. Zofunikira za ku Ulaya

Ku Europe, zofunikira zophera tizilombo toyambitsa matenda opumira zimayendetsedwa ndi European Committee for Standardization (CEN) ndi European Medicines Agency (EMA).CEN yapanga mulingo wa "EN ISO 17664:2017 - Sterilization of Medical Devices - Chidziwitso choperekedwa ndi Wopanga Pakupanga Zida Zamankhwala Zobwezeretsedwa" kuti azitsogolera opanga popereka malangizo opha tizilombo toyambitsa matenda pazida zamankhwala.

Kuphatikiza apo, EMA imapereka zitsogozo ndi malamulo ophera tizilombo toyambitsa matenda pazida zamankhwala, kuphatikiza zopumira."Guideline on the Quality, Safety, and Efficacy of Medical Devices" yoperekedwa ndi EMA ikugogomezera kufunikira kwa njira zoyenera zophera tizilombo toyambitsa matenda kuti zitsimikizire chitetezo cha odwala ndi mphamvu ya chipangizo.

Zofunikira zopha tizilombo toyambitsa matenda ndi malamulo opangira mpweya wopumira zimasiyana m'maiko osiyanasiyana, kuwonetsa kudzipereka kwapadziko lonse pachitetezo cha odwala komanso kupewa matenda.Ku China, National Health Commission ndi State Administration for Market Regulation imapereka malangizo ndi mfundo zopha tizilombo toyambitsa matenda, kuphatikizapo zopumira.Ku United States, bungwe la Food and Drug Administration ndi Association for the Advancement of Medical Instrumentation amagwira ntchito yofunika kwambiri pokhazikitsa malangizo ndi miyezo.Ku Europe, European Committee for Standardization ndi European Medicines Agency imawonetsetsa chitetezo ndi mphamvu ya zida zamankhwala kudzera mu malamulo awo.

Potsatira izi ndi malamulowa, akatswiri azachipatala amatha kukhala ndi malo otetezeka komanso osabala, kuchepetsa chiwopsezo cha matenda obwera chifukwa chaumoyo, ndikuwonetsetsa kuti zolowera kupuma zikuyenda bwino.Ndikofunikira kuti zipatala zizikhala zosinthidwa ndi malangizo aposachedwa kwambiri kuti apereke chithandizo chabwino kwambiri kwa odwala.

Kumbukirani, machitidwe oyenera opha tizilombo toyambitsa matenda samateteza odwala komanso amathandizira kuti machitidwe azachipatala apambane padziko lonse lapansi.