IiMfuno zeHlabathi kunye neMimiselo ye-Respiratory Ventilator Disinfection

Umfanekiso we-20230629145327

Ukubulala iintsholongwane ngokufanelekileyo kwii-ventilators kwizixhobo zonyango kudlala indima ebalulekileyo ekuqinisekiseni ukhuseleko lwesigulane kunye nokuthintela ukusasazeka kosulelo.

Amazwe ahlukeneyo kunye namashishini ezempilo aseke iimfuno ezithile kunye nemimiselo malunga nokubulawa kweentsholongwane kwii-ventilators zokuphefumla.Eli nqaku lijolise ekuphononongeni izikhokelo kunye nemigangatho ebekwe ngamazwe ahlukeneyo, egxininise e-China nakwamanye amazwe aphuhlileyo.Ngokuqonda le migaqo, iingcali zezempilo zinokuqinisekisa ukubulawa kweentsholongwane kwii-ventilators zokuphefumla kunye nokugcina umgangatho ophezulu wokhathalelo lwesigulana.

1. IiMfuno zoDisinfection eTshayina

E-China, iimfuno zokubulala iintsholongwane kwii-ventilators zokuphefumla zilawulwa yiKhomishini yezeMpilo yeSizwe (i-NHC) kunye noLawulo lukaRhulumente loLawulo lweMarike (SAMR)."Izikhokelo ze-Disinfection kwiiSettings zezempilo" ezikhutshwe yi-NHC zibonelela ngemiyalelo ecacileyo yokubulala iintsholongwane kwizixhobo zonyango, kubandakanywa ii-ventilators zokuphefumula.Ngokwezi zikhokelo, inkqubo yokubulala iintsholongwane kufuneka ilandele imigaqo yokucokiseka, ukusebenza kakuhle, kunye nokhuseleko.Izikhokelo zikwachaza ii-disinfectants ezicetyiswayo, ixesha lokuvezwa, kunye nokungena komoya okufanelekileyo ngexesha lenkqubo yokubulala iintsholongwane.

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Ngaphezu koko, i-SAMR yongamela ukuphunyezwa kwemigangatho efana "neZixhobo zoNyango - IiNkqubo zoLawulo loMgangatho - IiMfuno kwiiNjongo zoLawulo" (YY / T 0287) kunye "neZixhobo zeMedical - Ukusetyenziswa koLawulo loMngcipheko kwiZixhobo zoNyango" (YY / T 0466.1 ).Le migangatho iqinisekisa ukuba ii-ventilators zokuphefumla ziyahlangabezana neemfuno zomgangatho kwaye zibulawa ngokufanelekileyo iintsholongwane phambi kokusetyenziswa.

2. Iimfuno eUnited States

EUnited States, uLawulo lokuTya kunye neDrugs (i-FDA) lubonelela ngesikhokelo kunye nemigaqo yokubulawa kweentsholongwane kwii-ventilators zokuphefumla.Ngokwe-FDA's "Isikhokelo kuShishino kunye naBasebenzi be-FDA-Ukusetyenzwa kweZixhobo zoNyango kwiiSetingi zokhathalelo lweMpilo: Iindlela zoQinisekiso kunye nokuFakwa kweLebhile," ii-ventilators zokuphefumla kufuneka zingene kwinkqubo eqinisekisiweyo yokuhlaziya kwakhona ukuqinisekisa ukhuseleko kunye nokusebenza kwazo.

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Ukongezelela, i-Association for the Advancement of Medical Instrumentation (AAMI) ipapasha imigangatho efana ne-"ANSI / AAMI ST79: 2017 - Isikhokelo esiBanzi kwi-Sterilization kunye noQinisekiso lweNzalo kwiZibonelelo zezeMpilo."Lo mgangatho uchaza ezona ndlela zilungileyo zokubulala iintsholongwane kunye nokuvalwa inzala kwizixhobo zonyango, kubandakanya nezixhobo zokuphefumla, ukuthintela usulelo olunxulumene nokhathalelo lwempilo.

3. IiMfuno zaseYurophu

EYurophu, iimfuno zokubulala iintsholongwane kwii-ventilators zokuphefumla zilawulwa yiKomiti yaseYurophu yoMgangatho (CEN) kunye ne-European Medicines Agency (EMA).I-CEN iphuhlise umgangatho "I-EN ISO 17664: 2017 - Ukutshatyalaliswa kweZixhobo zezoNyango - Ulwazi oluya kubonelelwa nguMvelisi wokuPhathwa kweZixhobo zoNyango eziBuyiselwayo" ukukhokela abavelisi ekuboneleleni ngemiyalelo yokukhutshwa kwezixhobo zonyango.

Ngapha koko, i-EMA ibonelela ngezikhokelo kunye nemigaqo yokubulala iintsholongwane kwizixhobo zonyango, kubandakanya nezixhobo zokuphefumla."IsiKhokelo kuMgangatho, uKhuseleko, kunye nokuSebenza kweZixhobo zezoNyango" ezikhutshwe yi-EMA zigxininisa ukubaluleka kweenkqubo ezifanelekileyo zokubulala iintsholongwane ukuze kuqinisekiswe ukhuseleko lwesigulane kunye nokusebenza kwesixhobo.

 

Iimfuno zokubulala iintsholongwane kunye nemimiselo yee-ventilators zokuphefumla ziyahluka kumazwe ahlukeneyo, ebonisa ukuzibophelela kwehlabathi kukhuseleko lwesigulana kunye nolawulo losulelo.E-China, iKomishoni yezeMpilo yeSizwe kunye noLawulo lweLizwe loLawulo lweMarike lubonelela ngezikhokelo kunye nemigangatho yokubulala iintsholongwane kwizixhobo zonyango, kubandakanya ii-ventilators zokuphefumla.EUnited States, uLawulo lokuTya kunye neDrugs kunye noMbutho wokuPhucula iNgxowa-mali yezoNyango idlala indima ebalulekileyo ekusekeni izikhokelo kunye nemigangatho.EYurophu, i-European Committee for Standardization kunye ne-European Medicines Agency iqinisekisa ukhuseleko kunye nokusebenza kwezixhobo zonyango ngemimiselo yazo.

Ngokuthobela ezi mfuno kunye nemimiselo, iingcali zezempilo zinokugcina indawo ekhuselekileyo nengenazintsholongwane, ukunciphisa umngcipheko wosulelo olunxulumene nezempilo, kunye nokuqinisekisa ukusebenza ngokugqibeleleyo kwee-ventilators zokuphefumla.Kubalulekile ukuba amaziko okhathalelo lwempilo ahlale ehlaziywa nezikhokelo zamva nje kunye nemigangatho yokubonelela ngonakekelo olungcono kakhulu kwizigulana.

Khumbula, iindlela ezifanelekileyo zokubulala iintsholongwane azikhuseli kuphela izigulana kodwa zinegalelo kwimpumelelo epheleleyo yeenkqubo zokhathalelo lwempilo kwihlabathi liphela.

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