M'dziko lazogula zachipatala, kulondola ndi chirichonse. Kwa akatswiri ngati Mark Thompson, woyang'anira zogula zinthu ku chipatala ku USA, mawu akuti "chigoba opaleshoni," "Chopumira cha n95," ndi "nkhope mask" ali mbali ya lexicon ya tsiku ndi tsiku. Komabe, kusiyana kobisika koma kwakukulu pakati pawo, makamaka kupyolera mu FDA, zingakhale zovuta. The COVID-19 yadzidzidzi yazaumoyo wa anthu anabweretsa kusiyana kumeneku patsogolo, kukupanga kusefukira kwa zinthu zatsopano, malamulo, ndi chisokonezo. Monga wopanga zida zodzitetezera ku China, ine, Allen, ndayendetsa malo owongolera awa kuti ndipereke makasitomala ku North America ndi Europe. Kumvetsa FDANtchito yake singokhudza kutsata; ndi za kuonetsetsa chitetezo cha ogwira ntchito zachipatala ndi odwala. Bukuli lidzathetsa kusiyana kwa a chigoba opaleshoni ndi a chopumira, kufotokozera FDAndi olamulira, ndikupereka chidziwitso chomveka chomwe mukufuna kuti mupeze ufulu PPE pazochitika zilizonse.
Kodi Chigoba Chochita Opaleshoni M'maso mwa FDA ndi Chiyani Kwenikweni?
Malinga ndi FDA,a chigoba opaleshoni ndi lotayirira, lotayidwa chipangizo chachipatala kuti amalenga a chotchinga chakuthupi pakati pa pakamwa ndi mphuno wa wovala ndi zoipitsa zomwe zitha kupezeka pamalo omwe ali pafupi. Ndi a mankhwala amavala pa nkhope, koma ndikofunikira kumvetsetsa zoyambira zake kugwiritsidwa ntchito. A chigoba opaleshoni adapangidwa kuti atseke madontho akulu akulu, splashes, sprays, kapena splatter zomwe zingakhale ma virus ndi mabakiteriya, kuwaletsa kuti asafike kwa wovala mphuno ndi pakamwa.
Nthawi yomweyo, a chigoba opaleshoni cholinga chakenso ndi kuteteza ena. Imathandiza kutchera msampha wa mwiniwake kupuma katulutsidwe pamene akupuma, kulankhula, kapena kutsokomola. Ntchito ziwirizi ndichifukwa chake ndizofunikira panthawi ya a njira yachipatala. Komabe, chifukwa cha kusakwanira kwake, a chigoba opaleshoni sichimapanga chisindikizo cholimba pakati pa mask ndi nkhope yanu. Izi zikutanthauza kuti sizipereka zomwezo mlingo wa chitetezo motsutsana ndi kukopa tinthu tating'ono ta mpweya ngati a chopumira. The FDA amawongolera chigoba opaleshoni ngati a Kalasi II chipangizo chachipatala, kutanthauza kuti iyenera kukwaniritsa miyezo yeniyeni yogwirira ntchito kuti igulitsidwe mwalamulo ku U.S.
Kodi Chopumira Ndi Chosiyana Motani Ndi Chigoba Chopangira Opaleshoni?
Pamene a chigoba opaleshoni amapanga chotchinga, a chopumira ndi chidutswa cha zida zodzitetezera zopangidwira kusefera. Kusiyana kwakukulu kwagona pa cholinga chake ndi mapangidwe ake. A chopumira, monga Chopumira cha n95, ndi imodzi mwa zipangizo zotetezera kupuma opangidwa kuti agwirizane mwamphamvu ndi nkhope, kupanga chisindikizo mozungulira mphuno ndi pakamwa. Liti kuvala moyenera, chisindikizochi chimakakamiza kutulutsa mpweya ndikudutsa muzosefera.
Ntchito yoyamba ya a chopumira ndi ku kuteteza mwiniwake pokoka tinthu tating'ono ting'onoting'ono toopsa touluka m'mlengalenga. Ku United States, zida izi zimayesedwa ndikutsimikiziridwa ndi National Institute for Chitetezo ndi Thanzi Pantchito (NIOSH), gawo la CDC, molamulidwa Mtengo wa 42 CFR Gawo 84.N95" kutanthauza kuti chopumira amasefa osachepera 95% ya tinthu tating'onoting'ono kwambiri (0.3 micron). Chifukwa chake, a kusiyana pakati pa masks opangira opaleshoni ndi zopumira ndizofunikira: a chigoba opaleshoni ndi chotchinga cha madontho, pamene a chopumira ndi fyuluta ya tinthu tating'ono ta mpweya. Muyezo chigoba opaleshoni ayi a chopumira.
Ndiye, kodi N95 Respirator ndi Chida Chachipatala Choyendetsedwa ndi FDA?
Izi ndizomwe zimasokoneza nthawi zambiri, ndipo yankho ndilopanda pake. Ambiri N95 zopumira zimapangidwira zoikamo mafakitale, monga zomangamanga, kuteteza ogwira ntchito ku fumbi ndi zina. Izi zimatsimikiziridwa ndi NIOSH koma sizimaganiziridwa kuti ndi chipangizo chachipatala ndipo sizimayendetsedwa ndi FDA.
Komabe, gulu laling'ono lapadera limadziwika kuti "opaleshoni ya N95 yopumira." Mtundu uwu wa chopumira ndizopadera chifukwa zonse zatsimikiziridwa ndi NIOSH ngati Chopumira cha n95 ndi kuyeretsedwa ndi FDA ngati a chigoba opaleshoni. Izi zikutanthauza a opaleshoni N95 imapereka zabwino kwambiri padziko lonse lapansi: zimapereka mpweya wabwino kwambiri kusefedwa kwa particulate kuti muchepetse kuwonetseredwa ngati muyezo N95, ndi amapereka chitetezo chamadzimadzi chotchinga mwa a chigoba opaleshoni kuteteza ku splash ndi sprays. Izi opaleshoni N95 zopumira ndi cholinga ntchito mu makonda azaumoyo ndi ogwira ntchito yazaumoyo Pamachitidwe omwe amatha kupanga ma aerosols, omwe amapereka chitetezo chapamwamba kwambiri cha kupuma ndi madzimadzi amodzi chigoba.
Kodi "Barrier Face Covering" ndi chiyani ndipo Imalowa Kuti?
Teremuyo "Chophimba kumaso chotchinga" zinafala kwambiri pa nthawi ya mliri. Amatanthauza a mankhwala amavala pa nkhope zomwe zimakwirira wovalayo mphuno ndi pakamwa makamaka pofuna kuwongolera magwero—ndiko kuti, kuletsa wovalayo kufalitsa madontho ake a kupuma. Izi zimaphatikizapo masks a nsalu ndi zophimba kumaso zina zosavuta.
Mosiyana ndi a chigoba opaleshoni,a chophimba kumaso chotchinga nthawi zambiri samaganiziridwa kuti a chipangizo chachipatala ndi FDA pokhapokha chizindikiro chake chikusonyeza kuti ndi zachipatala. The FDA zoperekedwa mwachindunji malangizo kwa zinthu izi, kumveketsa kuti bola ngati sanapange zonena za Kutsekereza kwamadzimadzi kapena kusefera bwino, sangakhale pansi pa malamulo okhwima monga a chigoba opaleshoni. A chophimba kumaso chotchinga amapereka chotchinga chochepa chakuthupi ndipo sichiganiziridwa PPE. Iwo anapangidwira kwa anthu wamba ndi azaumoyo m'malo omwe siachipatala, osagwiritsidwa ntchito panthawi yosamalira odwala kapena popanga opaleshoni.
Kodi FDA Imayika Bwanji ndi Kuwongolera Chigoba Chopangira Opaleshoni?
The FDA imayendetsa a chigoba opaleshoni ngati a Kalasi II chipangizo chachipatala, zomwe zimaika m'gulu lachiwopsezo chochepa. Kugulitsa mwalamulo a chigoba opaleshoni ku U.S. nthawi zonse, wopanga akuyenera kupereka 510(k) chidziwitso cha malonda ku ku FDA. Kupereka uku kuyenera kukhala ndi umboni wosonyeza kuti chatsopanocho chigoba "ndizofanana kwambiri" pachitetezo komanso kuchita bwino kwa chipangizo chomwe chilipo kale pamsika.
Monga gawo la ndondomekoyi, a FDA imafunikira data yantchito kuti itsimikizire chigoba's mphamvu. Masks opangira opaleshoni amayesedwanso kwa zinthu zingapo zofunika:
- Kulimbana ndi Madzi: Imayesa luso la chigoba's yomanga kuti kuchepetsa zamadzimadzi kuyenda kudutsa zinthu.
- Bacterial Filtration Efficiency (BFE): The chigobaKukhoza kusefa mabakiteriya.
- Particulate Filtration Efficiency (PFE): The kuchuluka kwa kusefera kwa tinthu motsutsana ndi ma submicron particles.
- Kupuma mpweya (Delta P): Zimatsimikizira za chigoba imamasuka kuvala ndipo sichiletsa kupuma mopambanitsa.
- Kutentha: The chigoba ayenera kusonyeza kukana moto.
Miyezo yovutayi imatsimikizira kuti aliyense Masks opangidwa ndi FDA oyeretsedwa kupereka odalirika chotchinga chakuthupi chamadzimadzi ndi tinthu tating'onoting'ono nkhani monga ananenera.
Zomwe Zasintha Ndi Malamulo a FDA Panthawi ya COVID-19 Public Health Emergency?
Kufuna kosayerekezeka kwa zida zodzitetezera pa nthawi ya mliri adayambitsa FDA kuchitapo kanthu modabwitsa kuti awonjezere kupezeka. Kuti akwaniritse izi, a FDA idapereka ambulera EUA (Kuvomereza Kugwiritsa Ntchito Mwadzidzidzi) kwa chigoba opaleshoni zitsanzo zomwe sizinachitikepo muyeso wa 510 (k) chilolezo. Izi ambulera EUA ya masks opangira opaleshoni amalola kugwiritsa ntchito masks ena makonda azaumoyo, malinga ngati akwaniritsa zofunikira zogwirira ntchito. Ichi chinali chimodzi mwa angapo zida zodzitetezera za EUAs zosindikizidwa.
The FDA adaperekanso ma EUAs zopumira za COVID-19, kulola kuitanitsa ndi kugwiritsa ntchito okhawo opaleshoni ndi opumira osapanga opaleshoni omwe sanavomerezedwe ndi NIOSH koma adawonetsedwa kuti akwaniritse miyezo yofananira ndi N95. Njira izi zinali zofunika kwambiri poteteza ogwira ntchito zachipatala pamene zinthu zachikhalidwe zinali zochepa. Komabe, ndikofunikira kukumbukira kuti maulamuliro awa anali akanthawi ndipo amalumikizidwa mwachindunji ndi covid-19 zadzidzidzi zaumoyo. Aliyense chigoba opaleshoni kapena chopumira kugulitsidwa pansi pa EUA kumaganiziridwa kuti "zololedwa kugwiritsidwa ntchito mwadzidzidzi," osati "FDA-cleared" kapena "FDA-approved."
Kodi Zonse Zopumira za N95 Ndi Zoyenera Kwa Ogwira Ntchito Zaumoyo?
Ayi, ndipo ichi ndi kusiyana kofunikira kwa wogula aliyense wamankhwala. A muyezo mafakitale Chopumira cha n95, popereka zabwino kwambiri kusefera, si abwino kwa makonda azaumoyo. Zambiri mwa zopumirazi zimakhala ndi valavu yotulutsa mpweya - pulasitiki yaing'ono kutsogolo kwake chigoba zomwe zimapangitsa kukhala kosavuta kupuma. Ngakhale ili yabwino, valavu iyi imatulutsa mpweya wosasefedwa wa wovalayo m'chilengedwe, kugonjetsa cholinga chowongolera magwero m'munda wosabala.
A opaleshoni ya N95 yopumira idapangidwa mwachindunji kugwiritsidwa ntchito ndi azaumoyo. Ilibe valve yotulutsa mpweya ndipo, monga tafotokozera, imatsukidwanso ndi FDA kwa kukana madzimadzi. Chifukwa chake, mu a chisamaliro chaumoyo, makamaka panthawi yobereka kapena posamalira odwala opatsirana, okhawo omwe ali oyenera N95 ndi a opaleshoni ya N95 yopumira. Kugwiritsa ntchito mafakitale Chopumira cha n95 zitha kusokoneza chilengedwe komanso chitetezo cha odwala.
Monga Wogula, Ndiyenera Kuyang'ana Chiyani mu Masks Opangidwa ndi FDA Ochotsedwa?
Pofufuza a chigoba opaleshoni, kuyang'ana kupyola zonena zamalonda ndikofunikira. Monga opanga, timapereka izi kwa makasitomala athu kuti awonetse kutsata ndi khalidwe. Izi ndi zomwe muyenera kutsimikizira:
- 510(k) Chilolezo: Funsani za FDA 510 (k) nambala yachilolezo cha chigoba opaleshoni. Izi ndi zapagulu ndipo zitha kutsimikiziridwa pa FDA's database.
- Miyezo ya ASTM F2100: The FDA amazindikira muyezo ASTM F2100, amene mitengo ndondomeko masks ndi masks opaleshoni pa Level 1, 2, kapena 3 kutengera momwe amagwirira ntchito pamayeso asanu ofunikira omwe tawatchula kale. A Level 3 chigoba opaleshoni amapereka apamwamba kwambiri Kutsekereza kwamadzimadzi kapena kusefera bwino.
- Wopanga Wodalirika: Gwirizanani ndi wopanga yemwe ali ndi mbiri yopangira zida zamankhwala zomwe zimagwera mkati FDA malamulo. Yang'anani ziphaso monga ISO 13485, zomwe zimakhudzana ndi kasamalidwe kabwino ka zida zachipatala.
Kuonetsetsa kuti wothandizira wanu atha kukupatsani umboniwu ndikutsimikizirani kuti mukugula zovomerezeka chigoba opaleshoni zomwe zimapereka chitetezo ogwira ntchito ndi odwala anu, monga apamwamba athu chigoba cha nkhope ya opaleshoni yachipatala. Zathu Chigoba cha nkhope ya 3Ply Medical Face ndi njira ina yodalirika yomwe imakwaniritsa mfundo zokhwima.
Kodi Ndingatsimikizire Bwanji Ngati Chigoba Chopangira Opaleshoni Kapena Chopumira Ndi Chololedwa ndi FDA?
Kutsimikizira kuvomerezeka kwa a chigoba kapena chopumira ndi gawo lofunikira pakugula kuti mupewe zinthu zachinyengo.
- Zopumira Zovomerezeka za NIOSH: The CDC's National Personal Protective Technology Laboratory (NPPTL) ili ndi Mndandanda wa Zida Zovomerezeka. Mutha kufufuza mndandandawu kuti mutsimikizire ngati a chopumira, kuphatikizapo iliyonse N95 kapena opaleshoni N95 chitsanzo, ndi NIOSH-yovomerezeka.
- Za Masks Opangidwa ndi FDA Ochotsedwa: The FDA's 510(k) Premarket Notification database ndiye chida chachikulu. Mutha kusaka ndi wopanga kapena dzina la chipangizocho kuti mupeze tsatanetsatane wazinthu zina chigoba opaleshoni.
- Zazida Zapansi pa EUA: Pa nthawi yadzidzidzi, a FDA mndandanda wa zonse masks ovomerezeka opangira opaleshoni ndi zopumira patsamba lake. Mindanda iyi idafotokoza zomwe zitsanzo za chigoba cha opaleshoni zidaphatikizidwa pansi pa ambulera eua kwa masks opaleshoni. Ngakhale EUA ikutha, zolemba zakalezi zidakali zothandiza.
Kugwiritsa ntchito zinthu zovomerezekazi ndi njira yokhayo yotsimikizirira kuti masks opangira opaleshoni ndi zopumira za n95 mukugula ndi zovomerezeka. Chinthu ngati chathu FFP2 Mask, pamene akukumana ndi miyezo ya ku Ulaya, amasonyeza mtundu wa khalidwe ndi kusefera magwiridwe antchito omwe akuyembekezeka kuchokera kovomerezeka PPE.
Kodi FDA's Post-Emergency Plan for Masks and Respirators ndi iti?
Monga Zadzidzidzi zathanzi paumoyo wa anthu, ndi FDA ikupita kutali ndi kusinthika kwa ma EUAs ndikubwerera kumayendedwe okhazikika. Bungweli lasindikiza a ndondomeko ya kusintha kwa zipangizo zachipatala zomwe zidagulitsidwa kale pansi pa EUA. Izi malangizo limafotokoza nthawi ndi zofunika kwa opanga izi masks opaleshoni ndi kupuma kugonjera kwa chikhalidwe FDA chilolezo ngati akufuna kupitiliza kugulitsa zinthu zawo ku U.S.
Izi zikutanthauza kuti ambiri a iwo chigoba ndi chopumira mtundu womwe udawonekera pamsika panthawi ya mliriwu uyenera kutsata njira zolimba za 510(k). Kusintha kumeneku ndikofunikira pakuwonetsetsa chitetezo chanthawi yayitali komanso mtundu wamagetsi a U.S zida zodzitetezera. Kwa oyang'anira zogula, zikutanthauza kuti muyenera kuchita khama kuwonetsetsa kuti omwe akukupatsani akutsatira izi. ndondomeko ya kusintha kwa zipangizo zachipatala ndipo atha kupereka umboni wa zomwe zikubwera kapena kulandiridwa kumene FDA chilolezo kwa aliyense chigoba opaleshoni. Zimasonyeza kubwerera ku miyezo yapamwamba yomwe imalongosola zida zoyendetsedwa ndi FDA.
Nthawi yotumiza: Nov-06-2025