Imaski ye-rogical vs. I-N95 yokuphefumla: Isikhokelo se-FDA kwizixhobo ezikhuselayo kunye neflimu - ZhongxIng

Kwilizwe lokuthengwa kwezonyango, ukuchaneka yinto yonke. Abachwephesha njengoMarko e-Thompson, umphathi weNtengiso yeSibhedlele e-USA, imigaqo "imaski ye-sugical, ""Isixhobo esincedisa ukuphefumla se-n95, "Kwaye"Imaski yobuso"Ngaba yinxalenye yemihla ngemihla ye-lexicon. Ukanti, umntu ofihlakeleyo kodwa umahluko phakathi kwabo, ngakumbi ngelensi ye Fda, inokuba nzima. I Covid-19 impilo kawonke-wonke kawonkewonke Yazisa la mahluko kumphambili, ukudala umkhukula weemveliso ezintsha, imigaqo kunye nokudideka. Njengomvelisi we izixhobo zokhuselo lobuqu E China, i, Allen, ndihambele la macandelo olawulo ukubonelela abathengi kwilizwe liphela laseMelika naseYurophu. Ukuqonda i FdaIndima ayisiyo nje ukuthotyelwa; Imalunga nokuqinisekisa ukhuseleko lwe Abasebenzi bezempilo kunye nezigulana. Esi sikhokelo siza kuphinda-phindwa umahluko phakathi kwe imaski ye-sugical kwaye a umphenyi, Cacisa i FdaIgunya elilawulayo elilawulayo, kwaye linike ulwazi olucacileyo olifunayo ukuze ube nelungelo I-PPE ngayo nayiphi na imeko.

Yintoni kanye kanye imaski ye-readgical emehlweni e-FDA?

Ngokwe Fda, a imaski ye-sugical kukufanelekileyo, ukulahla Isixhobo sonyango edala i isithintelo somzimba phakathi kwe umlomo kunye nempumlo woyena mhle kunye nongcoliseko olunokubakho kwindawo ebonakalayo. Yi Imveliso inxibe ebusweni, kodwa kubalulekile ukuba uqonde iprayimari ukusetyenziswa kwenjongo. A imaski ye-sugical yenzelwe ukuvimba Iitoti ezinkulu, Splashes, ukutshiza, okanye i-spickter enokuqulatha Iintsholongwane kunye ne-bacteria, ukubathintela ekufikeleleni komthengisi impumlo kunye nomlomo.

Ngaxeshanye, a imaski ye-sugical yenzelwe ukukhusela abanye. Inceda ukuphatha umntu Imfundiso yokuphefumla Xa bephefumla, bathetha, okanye bakhohlela. Le ndima idlulileyo yiyo loo nto ibalulekile ngexesha lika-A Inkqubo yezonyango. Nangona kunjalo, ngenxa yokulunga kwayo, a imaski ye-sugical ayikhali itywina eliqinileyo phakathi kwe Imaski kunye nobuso bakho. Oku kuthetha ukuba ayiboneleli ngokufanayo Inqanaba lokukhuselwa ngokuchasene nokuphefumla amasuntswana amancinci anemoya njenge umphenyi. I Fda ilawula i imaski ye-sugical njenge Iklasi I-II isixhobo sezonyango II, Meme kufuneka ifezekise imigangatho ethile yokusebenza ukuze ithengiswe ngokusemthethweni kwi-U.S.

Injani i-respirar exhasa njani imaski ye-read?

Ngelixa imaski ye-sugical Yenza umqobo, a umphenyi sisiqwenga se izixhobo zokhuselo lobuqu yenzelwe ukuthoba. Umahluko ophambili ulele kwinjongo yayo noyilo. A umphenyi, njenge Isixhobo esincedisa ukuphefumla se-n95, yenye ye Izixhobo zokuphefumla zokuphefumla yenzelwe ukuba ilingane nkqo ebusweni, ukudala itywina elijikeleze i impumlo kunye nomlomo. Nini inxitywe ngokufanelekileyo.

Umsebenzi ophambili we umphenyi kuku Khusela umphathi ukusuka ekuphefumleni amasuntswana anobungozi. EUnited States, ezi zixhobo ziyavavanywa kwaye ziqinisekiswa liziko lesizwe le Ukhuseleko emsebenzini kunye neMpilo (Niosh), yinxalenye ye I-CDC, phantsi kommiselo I-42 cfr Icandelo 84. I "I-N95"Uyilo libonisa ukuba umphenyi Iifayile ezingama-95% zencinci kakhulu (0.3 micron) zovavanyo lwamasuntswana. Ke, i Umahluko phakathi kweMaski yeRhafu kwaye abaphetheyo babalulekile: A imaski ye-sugical sisithintelo samaconsi, ngelixa umphenyi sisihluzo sabantu abaqhelekileyo. Umgangatho imaski ye-sugical ayisiyo umphenyi.

Ke, ngumphathi-ntsholongwane we-N95 Isixhobo sonyango esilawulwa yi-FDA?

Le yindawo eqhubekayo yokudideka, kwaye impendulo yi-nuyed. Uninzi I-N95 Abaphengululi benzelwe useto lwemizi-mveliso, njengokwakha, ukukhusela abasebenzi eluthulini nasezinye iinkcukacha. Ezi zinto ziqinisekisiwe nguNiosh kodwa azithathwa njenge Isixhobo sonyango kwaye ayilawulwa ngu Fda.

Nangona kunjalo, udidi olukhethekileyo luyaziwa njenge "utyando n95. "Olu hlobo lwe umphenyi yahlukile kuba zombini iqinisekisiwe yi-niosh njenge Isixhobo esincedisa ukuphefumla se-n95 kwaye icinyiwe ngu Fda njenge imaski ye-sugical. Oku kuthetha ukuba utyando n95 Inika ezona zinto zibalaseleyo zehlabathi: Inika i-moya ebalaseleyo Ukuqulunqwa kokuqina ukunciphisa Ukuvezwa njengomgangatho I-N95, kwaye Inika i Ukhuseleko lweerringi ye imaski ye-sugical ukukhusela i-splashes kunye neeprayi. Ezi utyando n95 Abaphengululi be Yenzelwe ukusetyenziswa ngaphakathi Useto lokhathalelo lwempilo ngabasebenzi bezempilo Ngexesha lenkqubo enokuthi ivelise i-aerosols, ihambisa olona nqanaba liphezulu lokuphefumla kunye nokukhuselwa komntu imaski.

Yintoni "isithintelo seerries

Igama elithile "Isithintelo Services Esinga" Yaba yinto eqhelekileyo ngexesha lobhubhane. Ibhekisa kwi Imveliso inxibe ebusweni igubungela ubuqhetseba impumlo kunye nomlomo Ngokuyintloko ukuze kulawulwe ngumthombo-oko kukuthi, ukuthintela ukuphefumla ekusasazeni amachaphaza awo amaninzi. Oku kubandakanya i-comps imaski kunye nezinye izigqubuthelo zobuso obulula.

Ngokungafaniyo ne imaski ye-sugical, a isithintelo sokujongana ngokubanzi ayithathwa njenge Isixhobo sonyango nge Fda Ngaphandle kokuba iilebhile zibonisa ukuba zenzelwe ezonyango. I Fda ikhutshiwe isikhokelo Ngeemveliso, ukucacisa ukuba ixesha elide njengoko bengazange benze amabango malunga Isithintelo se-fluid okanye amanqanaba asebenzayo, ngekhe bathobele imigaqo-nkqubo efanayo ne-a imaski ye-sugical. A isithintelo sokujongana ibonelela ngesithintelo esincinci esincinci kwaye asiqwalaselwanga I-PPE. Zenzelwe i Abasebenzi boluntu ngokubanzi kunye nabasebenzi bezempilo Kwiimeko ezingezizo ezonyango, hayi ukusetyenziswa ngexesha lokhathalelo lwezigulana okanye iinkqubo zotyando.

Ngaba i-FDA iqalile kwaye ilawule njani imaski yokuhlinzwa?

I I-FDA ilawula a imaski ye-sugical njenge Iklasi I-II isixhobo sezonyango II, okubeka kwicandelo lomngcipheko eliphakathi. Intengiso ngokusemthethweni imaski ye-sugical Kwi-U.S. Ngaphantsi kweemeko eziqhelekileyo, umenzi kufuneka angenise i-510 (k) Isaziso seNkuluvo kwi Fda. Olu ngeniso kufuneka lube nobungqina bokuba entsha imaski "Ilingana kakhulu" kukhuseleko kunye nokusebenza kakuhle kwisixhobo sele sikwintengiso.

Njengenxalenye yale nkqubo, Fda ifuna idatha yentsebenzo yokungqina i imaskiUkusebenza. Imaski ye-subgical iyavavanywa Kwindawo ezininzi eziphambili:

• Ukunganyangeki kwe-fluid: Amanyathelo okukwazi kwe imaskiUkwakhiwa ukunciphisa ulwelo ukuba luhambe ngendlela.
• I-Bactery Flight (bFA): I imaskiUkukwazi ukucoca intsholongwane.
• Ukusebenza kweeffe (PFE): I isidanga sokuqulunqa ngokuchasene namasuntswana asezantsi.
• Ukuphefumla (desta p): Iqinisekisa i imaski ukhululekile ukunxiba kwaye ungathinteli kakhulu ukuphefumla.
• Ukuvutha: I imaski Kufuneka ubonise ukumelana ne-flame.
  Le migangatho ingqongqo iqinisekisa ukuba nayiphi na Imaski ye-FDA Nikezela ngokuthembekileyo isithintelo somzimba kwii-fluids kunye nethagethi into njengoko ibango.

Yintoni etshintshileyo ngommiselo we-FDA ngexesha leCovid-19 yezempilo yoluntu?

Ibango elingazange libonwe izixhobo zokhuselo lobuqu Ngexesha lobhubhane iqhubele phambili Fda ukuthatha amanyathelo angaqhelekanga ukonyusa ukubonelelwa. Ukufezekisa oku, I-FDA ikhuphe iambrela yea (Ugunyaziso lokuSebenzisa uNgxamiseko) imaski ye-sugical Iimodeli ezingakhange zisebenze inkqubo ye-510 (k) yenkqubo. Le iambrela ea yemaski ye-sub ivumele imaski ethile ukuba isetyenziswe ngaphakathi Useto lwempilo, ngokuxhomekeka ukuba badibana neekhrayitheriya zentsebenzo ezithile. Le yenye yabaliqela izixhobo zokukhusela i-Euas ikhutshiwe.

I Fda ikhuphe i-Euas ye Abaphengululi beComph-19, ukuvumela ukungenisa elizweni kwaye UKUSETYENZISWA KOKUGQIBELA kunye nabaphengululi abangenzi utyando ababengavunyelwanga i-wiosh-kuvunyiwe ukuba badibane nemigangatho ehambelana ne I-N95. La manyathelo alulekile ukukhusela Abasebenzi bezempilo Xa iimpahla zemveli zazinqabile. Nangona kunjalo, kubalulekile ukukhumbula ezi zigunyaziso zethutyana kwaye ziboshwe ngqo kwi Covid-19 impilo kawonke-wonke kawonkewonke. Nantoni na imaski ye-sugical okanye umphenyi Intengiso phantsi kwe-EUA ithathelwe ingqalelo "igunyaziswe ukusetyenziswa kungxamiseko, "Hayi" i-FDA-icinyiwe "okanye" ivunyiwe. "

Ngaba zonke ii-N95 ii-respirators zilungele abasebenzi bezempilo?

Hayi, kwaye olu luphawu olubaluleke kakhulu kulo nawuphi na umthengi wonyango. Imveliso esemgangathweni Isixhobo esincedisa ukuphefumla se-n95, ngelixa ubonelela kakhulu ukuthoba, ayilunganga Useto lokhathalelo lwempilo. Uninzi lwaba bantu baphetheyo bane-velo yoxinzelelo-isangqa esincinci seplastiki ngaphambili kwe imaski Oko kwenza ukuba kube lula ukuphefumla ngaphandle. Ngelixa ukhululekile, le valve ikhupha umphefumlo ongafakwanga kwindalo esingqongileyo, ukoyisa injongo yolawulo lomthombo kwintsimi ye-stele.

A utyando n95 yenzelwe ngokukodwa Sebenzisa abasebenzi bezempilo. Ayinayo ivalve ephumeleleyo kwaye, njengoko kuchaziwe, iconjiswe ngu Fda Ukunganyangeki kwamanzi. Ke ngoko, kwi Ukuseta kwezempilo, ngakumbi ngexesha leenkqubo ze-STTLE okanye xa unyamekela izigulana ezosulelayo, okufanelekileyo kuphela I-N95 yi utyando n95. Sebenzisa umzi-mveliso Isixhobo esincedisa ukuphefumla se-n95 inokulalanisa imeko ye-Stead kunye noKhuseleko loNogulelo.

Njengomthengi, kufuneka ndijonge ntoni kwiimaski ze-FDA-ezicocekileyo?

Xa ukhangele i imaski ye-sugical, ujonge ngaphaya kwebango lokuthengisa kubalulekile. Njengomvelisi, sinikezela ngale datha kubaxumi bethu babo ukubonisa ukuthotyelwa kunye nomgangatho. Nantsi into ekufuneka uyiqinisekise:

• I-510 (k) imvume: Cela Fda I-510 (k) inombolo ye imaski ye-sugical. Olu lulwazi loluntu kwaye lunokuqinisekiswa kwi FdaIndawo yedatha.
• I-ASTM F2100 Inqanaba: I Fda iqaphela i-ASTM F2100 imigangatho, amaxabiso amaxabiso Inkqubo yemaski kwaye Imaski ye-subgical Kwinqanaba loku-1, 2, okanye isi-3 ngokusekwe kwintsebenzo yabo kwiimvavanyo ezintlanu eziphambili ezichazwe ngaphambili. Inqanaba 3 imaski ye-sugical inika eyona iphezulu Isithintelo se-fluid okanye amanqanaba asebenzayo.
• Umenzi odumileyo: Iqabane elinomvelisi onerekhodi yokuvelisa izixhobo zonyango eziwela ngaphakathi Fda Imigaqo. Jonga iziqinisekiso ezinjenge-ISO 13485, ephathelele kwiinkqubo zolawulo lomgangatho wezonyango.

Ukuqinisekisa ukuba umthengisi wakho unokubonelela obu bungqina uqinisekile ukuba uyithengile imaski ye-sugical Oko kubonelela ngokhuseleko lwabasebenzi kunye nezigulana ezifunwayo, ezinje ngomgangatho wethu omkhulu Ubuso bonyango. Bethu Imaski ye-3P ye-3P yenye indlela ethembekileyo ethembekileyo ehlangabezana nemigangatho esemgangathweni.

Ndingaqinisekisa njani ukuba imaski yokuhlinzwa okanye igunyaziwe igunyazisiwe yi-FDA?

Ukuqinisekisa ubunyani be-a imaski okanye umphenyi linyathelo elibalulekileyo ekuthengweni kwenu ukunqanda iimveliso zobuxoki.

• Ii-respiators ezivunyiweyo zeNiosh: I I-CDC'S I-Laborive yeTekhnoloji yeSizwe (I-NPTPL) igcina uluhlu lwezixhobo eziqinisekisiweyo. Ungakhangela olu luhlu ukuze uqinisekise ukuba umphenyi, kubandakanya nayiphi na I-N95 okanye utyando n95 Imodeli, i-Niosh-yamkelwe.
• Ii-DDA ezicocekileyo ze-FDA: I FdaI-TOSTE yeSarkti yeSayethi yeNkuluvo yeNkulumbuso sisibonelelo esiphambili. Ungakhangela ngomenzi okanye igama lesixhobo ukufumana iinkcukacha ezichaziweyo imaski ye-sugical.
• Kuba izixhobo eziphantsi kwe-EUA: Ngexesha likaxakeka, Fda Uluhlu lwezinto ezigciniweyo Imaski egunyazisiweyo kunye nokuphefumla kwiwebhusayithi yayo. Olu luhlu luchaziweyo Imodeli yemaski yeMaski babandakanyiwe phantsi kwe iambrela ea yemaski ye-sub. Nangona i-EU iphela, olu lugcino luhlala lubhekisa.

Sebenzisa ezi zixhobo zisemthethweni kukuphela kwendlela yokuqinisekisa ukuba Imaski ye-sugic kunye nee-N95 zokwanda Ukuthenga izinto ezisemthethweni. Imveliso njengawethu I-FFP2 imaski, ngelixa dibana nemigangatho yaseYurophu, ibonisa uhlobo lomgangatho kwaye ukuthoba Intsebenzo elindelweyo evela kwisemthethweni I-PPE.

Sithini isicwangciso se-FDA se-FDA yemaski yemaski kunye nabaphengululi?

Njenge iphele impilo yexesha likawonke-wonke, Fda ihamba kude nokuguquguquka kwe-Euas kwaye ibuye kwiinkqubo zomthetho. I-Arhente ipapashe a Isicwangciso senguqu kwezixhobo zonyango ezazithengiswa phantsi kwe-EUA. Le isikhokelo chaza umgca wexesha kunye neemfuno zabavelisi bezi Imaski ye-sugic kunye nee-respirators ukungenisa ngokwesiko Fda Imvume ukuba banqwenela ukuqhubeka nokuthengisa iimveliso zabo kwi-U.S.

Oku kuthetha ukuba uninzi lwe imaski kwaye umphenyi Iimpawu ezibonakala kwimakethi ngexesha lobhubhane ziya kufuneka zingene kwiNkqubo ye-510 (k). Olu tshintsho lubalulekile ekuqinisekiseni ukhuseleko lwexesha elide kunye nomgangatho we-U.S. izixhobo zokhuselo lobuqu. Kubaphathi bempahla yokuthenga, oko kuthetha ukuba kuya kufuneka ukuba ukhuthele ekuqinisekiseni abathengisi bakho balandela le nto Isicwangciso senguqu kwezixhobo zonyango kwaye inokubonelela ubungqina bokuba uza kufikelwa okanye osandula ukufunyanwa Fda Ukucoca ngayo nayiphi na imaski ye-sugical. Iphawula ukubuyela kwimigangatho ephezulu echaza izixhobo ezilawulwa yi-FDA.