Ukubulala amagciwane ngendlela efanele kwama-ventilators emishinini yezokwelapha kudlala indima ebalulekile ekuqinisekiseni ukuphepha kwesiguli kanye nokuvimbela ukusabalala kwezifo.
Amazwe ahlukene kanye nezimboni zokunakekelwa kwempilo zithole izidingo nemithethonqubo ethile mayelana nokubulawa kwamagciwane kwama-ventilators okuphefumula.Lesi sihloko sihlose ukuhlola imihlahlandlela nezindinganiso ezibekwe izizwe ezihlukahlukene, ezigxile eShayina nakwamanye amazwe athuthukile.Ngokuqonda le mithetho, ochwepheshe bezokunakekelwa kwempilo bangaqinisekisa ukubulawa kwamagciwane okusebenzayo kwama-ventilators okuphefumula futhi bagcine izinga eliphezulu lokunakekelwa kwesiguli.
1. Izidingo Zokubulala Amagciwane e-China
E-China, izidingo zokubulala amagciwane kuma-ventilators okuphefumula zilawulwa yi-National Health Commission (NHC) kanye ne-State Administration for Market Regulation (SAMR).“Imihlahlandlela Yokubulala Amagciwane Ezilungiselelweni Zokunakekelwa Kwezempilo” ekhishwe yi-NHC inikeza imiyalelo enemininingwane yokubulala amagciwane emishinini yezokwelapha, okuhlanganisa nama-ventilators okuphefumula.Ngokwale mihlahlandlela, inqubo yokubulala amagciwane kufanele ilandele izimiso zokunemba, ukusebenza kahle, nokuphepha.Imihlahlandlela iphinde icacise izibulala-magciwane ezinconyiwe, isikhathi sokuchayeka, kanye nokungena komoya okufanele ngesikhathi senqubo yokubulala amagciwane.
Ngaphezu kwalokho, i-SAMR yengamela ukuqaliswa kwamazinga afana nokuthi “Amadivayisi Ezokwelapha – Amasistimu Okuphatha Ikhwalithi – Izimfuneko Zezinjongo Zokulawula” (YY/T 0287) kanye “Namadivaysi Ezokwelapha – Ukusetshenziswa Kokulawulwa Kobungozi Emishinini Yezokwelapha” (YY/T 0466.1 ).Lawa mazinga aqinisekisa ukuthi ama-ventilators okuphefumula ahlangabezana nezidingo zekhwalithi futhi abulawa amagciwane ngendlela efanele ngaphambi kokusetshenziswa.
2. Izimfuneko e-United States
E-United States, iFood and Drug Administration (FDA) inikeza isiqondiso nemithethonqubo yokubulala amagciwane ama-ventilators okuphefumula.Ngokusho kwe-FDA's "Isiqondiso Sezimboni Nabasebenzi Be-FDA - Ukucubungula Amadivayisi Ezokwelapha Ezilungiselelweni Zokunakekelwa Kwezempilo: Izindlela Zokuqinisekisa Nokulebula," ama-ventilators okuphefumula kufanele enze inqubo eqinisekisiwe yokucubungula kabusha ukuze kuqinisekiswe ukuphepha nokusebenza kwawo.
Ukwengeza, i-Association for the Advancement of Medical Instrumentation (AAMI) ishicilela amazinga afana ne-“ANSI/AAMI ST79:2017 – Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.”Leli zinga lichaza izinqubo ezihamba phambili zokubulala amagciwane kanye nokuvalwa inzalo kwemishini yezokwelapha, okuhlanganisa nama-ventilators okuphefumula, ukuvimbela izifo ezihambisana nokunakekelwa kwezempilo.
3. Izidingo zaseYurophu
E-Europe, izidingo zokubulala amagciwane kuma-ventilators okuphefumula zilawulwa yi-European Committee for Standardization (CEN) kanye ne-European Medicines Agency (EMA).I-CEN ithuthukise izinga elithi “EN ISO 17664:2017 – Ukuvalwa Kwamadivayisi Ezokwelapha – Ulwazi Oluzohlinzekwa Umkhiqizi Wokucubungula Amadivayisi Ezokwelapha Angasebenza Kabusha” ukuze iqondise abakhiqizi ekunikezeni imiyalelo yokubulala amagciwane emishinini yezokwelapha.
Ngaphezu kwalokho, i-EMA ihlinzeka ngemihlahlandlela nemithethonqubo yokubulala amagciwane emishini yezokwelapha, okuhlanganisa nama-ventilators okuphefumula.“Umhlahlandlela Wekhwalithi, Ukuphepha, kanye nokusebenza Okusebenzayo Kwamadivayisi Ezokwelapha” okhishwe i-EMA ugcizelela ukubaluleka kwezinqubo ezifanele zokubulala amagciwane ukuze kuqinisekiswe ukuphepha kwesiguli nokusebenza kwedivayisi.
Izidingo zokubulala amagciwane kanye nemithethonqubo yama-ventilators okuphefumula ziyehluka emazweni ahlukene, okubonisa ukuzibophezela kwamazwe ngamazwe ekuphepheni kwesiguli nasekulawuleni ukutheleleka.E-China, Ikhomishini Yezempilo Kazwelonke kanye Nokuphathwa Kwezwe Lokulawulwa Kwemakethe bahlinzeka ngemihlahlandlela namazinga okubulala amagciwane emishini yezokwelapha, okuhlanganisa nama-ventilators okuphefumula.E-United States, i-Food and Drug Administration kanye ne-Association for the Advancement of Medical Instrumentation badlala indima ebalulekile ekusunguleni imihlahlandlela namazinga.E-Europe, i-European Committee for Standardization kanye ne-European Medicines Agency iqinisekisa ukuphepha nokusebenza kahle kwemishini yezokwelapha ngemithetho yayo.
Ngokuthobela lezi zidingo nemithethonqubo, ochwepheshe bezokunakekelwa kwempilo bangagcina indawo ephephile neyinyumba, banciphise ubungozi bokutheleleka okuhlobene nokunakekelwa kwezempilo, futhi baqinisekise ukusebenza kahle kwama-ventilators okuphefumula.Kubalulekile ukuthi izikhungo zokunakekelwa kwempilo zihlale zinolwazi ngezinkombandlela nezindinganiso zakamuva ukuze zinikeze ukunakekelwa okungcono kakhulu ezigulini.
Khumbula, izinqubo ezifanele zokubulala amagciwane azivikeli iziguli kuphela kodwa futhi zifaka isandla empumelelweni iyonke yezinhlelo zokunakekelwa kwezempilo emhlabeni wonke.
