Mask ya mask na N95 Ubuhumetswe: Umuyobozi wa FDA mubikoresho byo kurinda kugiti cyawe no kugisimba - Zhongxing

Mw'isi yo gutanga amasoko, prisision nibintu byose. Ku banyamwuga bameze nka Mark Thompson, umuyobozi ushinzwe amasoko mu bitaro muri Amerika, ingingo "mask yo kubaga, ""N95, "na"isura ya mask"Hariho igice cya buri munsi. Nyamara, itandukaniro rikomeye ariko rikomeye hagati yabo, cyane cyane binyuze muri lens ya Fda, birashobora gutoroshye. The Covid-19 Ibihe byihutirwa yazanye itandukaniro ku isonga, kurema umwuzure wibicuruzwa bishya, amabwiriza, n'urujijo. Nkumurimo wa Ibikoresho byo Kurinda Umuntu Mu Bushinwa, njye, Allen, nakomeje aya makuru ngenderwaho kubakiriya muri Amerika ya Ruguru n'Uburayi. Gusobanukirwa FdaUruhare ntirufite ku kubahiriza gusa; Byerekeranye no guharanira umutekano wa Abakozi bashinzwe ubuzima n'abarwayi. Aka gatabo kazagaragaza itandukaniro riri hagati ya a mask yo kubaga na a guhumeka, gusobanura Fda'Ubuyobozi bushinzwe kugenzura, kandi butanga amakuru asobanutse ugomba gutanga isoko iburyo Ppe Ibyo ari byo byose.

Ni ubuhe buryo budasanzwe mu maso ya FDA?

Ukurikije Fda, a mask yo kubaga ni ikintu kiboneye, cyakozwe igikoresho cyo kwa muganga irema a Inzitizi z'umubiri hagati ya umunwa n'amazuru y'uwambaye kandi ashobora kwanduza ahantu hitowe. Ni a Ibicuruzwa byambarwa mumaso, ariko ni ngombwa kumva abanza Gukoresha. A mask yo kubaga yagenewe guhagarika Ibitonyanga byinshi, amasuka, abakura, cyangwa gukemurwa bishobora kuba birimo virusi na bagiteri, kubabuza kugera ku wambaye izuru n'umunwa.

Icyarimwe, a mask yo kubaga nabyo bigamije kurinda abandi. Ifasha gutunganya uwambaye Ibanga ry'ubuhumekero Iyo bahumeka, ibiganiro, cyangwa inkorora. Uru ruhare rutandukanye niyo mpamvu ari ngombwa mugihe cya Uburyo bwo kwivuza. Ariko, kubera ikintu cyacyo gihagije, a mask yo kubaga ntabwo ikora ikimenyetso gifatanye hagati ya mask no mu maso hawe. Ibi bivuze ko idatanga kimwe urwego rwo kurinda kurwanya guhumeka ibice bito bya airborne nka a guhumeka. The Fda agenga mask yo kubaga nka a Icyiciro cya II igikoresho cyubuvuzi, bivuze ko igomba kuba yujuje ubuziranenge bwihariye kugirango amenyekane byemewe n'amategeko muri Amerika

Nigute uwahumeka atandukanye na mask yo kubaga?

Mugihe a mask yo kubaga Kurema inzitizi, a guhumeka nigice cya Ibikoresho byo Kurinda Umuntu yagenewe gukanda. Itandukaniro ryingenzi riri mubikorwa byayo. A guhumeka, nka an N95, ni imwe muri Ibikoresho byo gukingira ubuhumekero yagenewe guhuza neza mumaso, gukora kashe hafi ya izuru n'umunwa. Ryari yambarwa neza, Imbaraga zikidodo zihumeka kandi zihumye umwuka unyura muyungurura.

Imikorere yibanze ya a guhumeka ni Rinda uwambaye kuva guhumeka ibintu byangiza. Muri Amerika, ibi bikoresho birageragezwa no kwemezwa n'ikigo cy'igihugu gishinzwe Umutekano wumwuga nubuzima (Niosh), igice cya CDC, munsi y'amabwiriza 42 CFR Igice cya 84. "N95"Igenamigambi risobanura ko guhumeka muyungurura byibuze 95% ya mantike nto cyane (micron) ibizamini. Kubwibyo, Uwiteka itandukaniro hagati ya masike yo kubaga n'abahutira bafite akamaro: a mask yo kubaga ni inzitizi yo kurya, mugihe a guhumeka ni akayunguruzo k'ibinyabuzima byo mu kirere. Bisanzwe mask yo kubaga ntabwo ari a guhumeka.

Rero, ni N95 ihumeka igikoresho cyubuvuzi cyagengwa na FDA?

Iyi ni ingingo yakunze kwitiranya, kandi igisubizo ni nuiced. Byinshi N95 Ibisubizo byateguwe ku igenamiterere ry'inganda, nko kubaka, kurengera abakozi mu mukungugu no ku bundi buryo. Ibi byemejwe na Niosh ariko ntibifatwa nka igikoresho cyo kwa muganga kandi ntibigengwa na Fda.

Ariko, igice cyihariye cyicyiciro kizwi nka "Kubaga N95 Wowe. "Ubu bwoko bwa guhumeka ni umwihariko kuko byombi byemejwe na Niosh nka an N95 kandi yahanaguwe na Fda nka a mask yo kubaga. Ibi bivuze a kubaga N95 itanga ibyiza byisi byombi: itanga ikirere gisumba guhuza ibice kugirango bigabanye kwerekana nkibisanzwe N95, na itanga Kurinda amazi ya mask yo kubaga kurinda amashanyarazi no kurya. Ibi kubaga N95 Abahutira ni bigenewe gukoreshwa in Igenamiterere ryubuzima nabakozi bashinzwe ubuzima Mugihe cyubu buryo bushobora kubyara aerotos, butanga urwego rwohejuru rwibihumekero no kurinda amazi murwego rumwe mask.

Niki "Inzitizi itwikiriye" kandi ikwiranye he?

Ijambo "Inzitizi Isura" yarushijeho gukomera mugihe icyorezo. Bivuga a Ibicuruzwa byambarwa mumaso ikubiyemo uwambaye izuru n'umunwa Ahanini kugirango ugenzure neza - ni ukuvuga kugirango wirinde uwambaye gukwirakwiza ibitonyanga byabo. Harimo masike yimyenda nibindi bitwikiriye isura yoroshye.

Bitandukanye na mask yo kubaga, a Inzitizi Isura muri rusange ntabwo afatwa a igikoresho cyo kwa muganga na Fda Keretse niba ikirango cyacyo cyerekana ko ari intego zubuvuzi. The Fda byatanzwe ubuyobozi Kuri ibyo bicuruzwa, bisobanure ko igihe cyose batavuze kubyerekeye Inzitizi ya fluid cyangwa urwego rwo hejuru, ntibari kugengwa namabwiriza amwe nka a mask yo kubaga. A Inzitizi Isura itanga inzitizi ntoya yumubiri kandi ntabwo isuzumwa Ppe. Bigenewe Uwiteka Abakozi muri rusange baturage n'abakozi bashinzwe ubuzima Mubihe bitarimo amavuriro, ntabwo bikoreshwa mugihe cyo kwihangana cyangwa uburyo bwo kubaga.

Nigute FDA itondekanya kandi igenga mask yo kubaga?

The FDA igenga a mask yo kubaga nka a Icyiciro cya II igikoresho cyubuvuzi, niyihe shyira mu cyiciro giciriritse. Ku isoko byemewe n'amategeko a mask yo kubaga muri Amerika mubihe bisanzwe, uruganda rugomba gutanga 510 (k) Kumenyesha Premariket Kuri Fda. Iyi nyandiko igomba kuba irimo ibimenyetso byerekana ko nshya mask ni "bihwanye cyane" mumutekano no gukora neza kubikoresho bimaze ku isoko.

Mugice cyiki gikorwa, the Fda bisaba amakuru yimikorere kugirango yerekane mask'Imikorere myiza. Masike yo kubaga nayo irageragezwa Kubintu byinshi byingenzi:

• Kurwanya Amazi: Ingamba ubushobozi bwa maskKuba ubwubatsi bwo kugabanya imizindo yo kunyura mubikoresho.
• Bagiteri Filtration Efficy (BFE): The mask'Ubushobozi bwo kuyungurura bagiteri.
• Kwinjiza ibice byumvikana neza (PFE): The Urwego rwo hejuru kurwanya uduce twa Micron.
• Guhumeka (Delta P): Iremeza mask ni byiza kwambara kandi ntibibuza guhumeka cyane.
• Akaba: The mask igomba kwerekana ko flame irwanya.
  Aya mahame akomeye yerekana ko umuntu uwo ari we wese FDA-Yakuweho Masike tanga kwizerwa inzitizi yumubiri kumazi no kwicogora ibintu nkuko byavuzwe.

Icyahindutse hamwe n'amabwiriza ya FDA mu gihe cya Covid CALV-19 byihutirwa?

Icyifuzo kitigeze kibaho Ibikoresho byo Kurinda Umuntu Mugihe icyorezo cyateye Uwiteka Fda gufata ingamba zidasanzwe zo kongera gutanga. Kugirango ubigereho, the FDA yatanze umbrella Eua (Ibyihutirwa Koresha Uruhushya) Kuri mask yo kubaga icyitegererezo ntabwo cyari cyarakemutse gisanzwe 510 (k). Ibi Umbrella Eua for masike yo kubaga yemereye masike zimwe na zimwe zikoreshwa muri Igenamiterere ryubuzima, mugihe bahuye nibipimo byagenwe. Iyi yari imwe muri benshi Ibikoresho byo kurinda umuntu Euas Yatanzwe.

The Fda yatanze kandi euas kuri Ibisubizo kuri Covid-19, kwemerera gutumiza mu mahanga kandi Gukoresha gusa gusa kubaga n'abahubaga batiyubatsa batari niosh-yemejwe ariko bagaragajwe kugira ngo babone amahame yagereranijwe na an N95. Izi ngamba zari zikomeye zo kurengera Abakozi b'ubuzima Iyo ibikoresho gakondo byari bike. Ariko, ni ngombwa kwibuka ubwo burenganzira bwari bwigihe gito kandi buhambiriye kuri Covid-19 Ibihe byihutirwa. Icyaricyo cyose mask yo kubaga cyangwa guhumeka Kwangizwa no muri Eua byafatwagaga "Yemerewe gukoresha byihutirwa, "Ntabwo" yakuweho "cyangwa" FDA. "

Bose N95 basigaye bibereye abakozi bashinzwe ubuzima?

Oya, kandi iyi ni itandukaniro rikomeye kubaguzi bose mubuvuzi. Inganda zisanzwe N95, mugihe utanga ibyiza gukanda, ntabwo ari byiza kuri Igenamiterere ry'ubuzima. Benshi muri aba bashishoza bafite valve yambutse - uruziga ruto rwa plastiki imbere ya mask ibyo biroroshye guhumeka. Mugihe cyoroshye, iyi valve irekura umwuka udakwiriye ibidukikije mubidukikije, utsinda intego yo kugenzura inkomoko mu murima wibeshya.

A Kubaga N95 Wowe yateguwe byumwihariko Koresha n'abakozi bashinzwe ubuzima. Ntabwo ifite impanuka yuzuye kandi, nkuko byavuzwe, nayo yahanaguwe na Fda Kurwanya amazi. Rero, muri a Igenamiterere ry'ubuzima, cyane cyane mugihe cya sterile cyangwa mugihe wita kubarwayi banduye, gusa bikwiye N95 ni a Kubaga N95 Wowe. Ukoresheje inganda N95 irashobora guhungabanya ibidukikije bya sterile n'umutekano wihangana.

Nkumuguzi, ni iki nkwiye gushakisha muri masike ya FDA-yakuweho?

Iyo uhiga a mask yo kubaga, urebye ibirenze ikibazo cyo kwamamaza ni ngombwa. Nkumukora, dutanga aya makuru kubakiriya bacu kwerekana ko twubahiriza no gutangaza. Dore ibyo ugomba kugenzura:

• 510 (k) kwemererwa: Saba Uwiteka Fda 510 (k) nimero yo gukuraho kuri mask yo kubaga. Iyi ni amakuru rusange kandi arashobora kugenzurwa kuri FdaUbubikoshingiro.
• Inzoga ya ASTM F2100: The Fda izi ASTM F2100, ikigereranyo maskes na masike yo kubaga Ku rwego rwa 1, 2, cyangwa 3 ukurikije imikorere yabo mubizamini bitanu byingenzi byavuzwe haruguru. Urwego 3 mask yo kubaga itanga hejuru Inzitizi ya fluid cyangwa urwego rwo hejuru.
• Uruganda ruzwi: Umufatanyabikorwa ufite uruganda rufite amateka yo gukora Ibikoresho byubuvuzi biri imbere Fda amabwiriza. Shakisha ibyemezo nka iso 13485, bijyanye na sisitemu yubuyobozi bwiza.

Kwemeza ko utanga isoko yawe ashobora gutanga ibi bimenyetso bigufasha kugura byemewe mask yo kubaga ibyo bitanga uburinzi abakozi bawe n'abarwayi bakeneye bakeneye, nkubwiza bwacu buhebuje Ubuvuzi bwo kubaga muri mask. Ibyacu Byashobokaga mask yubuvuzi nubundi buryo bwizewe buhura nibipimo ngenderwaho.

Nigute nshobora kugenzura niba mask yo kubaga cyangwa ubuhumekewe yemerewe na FDA?

Kugenzura ubuzimagato bwa a mask cyangwa guhumeka ni intambwe ikomeye mugutanga amasoko kugirango wirinde ibicuruzwa byiganano.

• Abahumanya ba Niosh-bemerewe: The CDC' Laboratoire y'ikoranabuhanga mu gihugu (NPPTL) ikomeza urutonde rwibikoresho byemewe. Urashobora gushakisha uru rutonde kugirango wemeze niba a guhumeka, harimo na kimwe N95 cyangwa kubaga N95 icyitegererezo, ni niosh-yemejwe.
• Kuri FDA-Yakuweho Masike yo kubaga: The Fda'S 510 (k) Ububikoshingiro bwibanze nububiko bwibanze. Urashobora gushakisha ukoresheje uwukora cyangwa izina ryibikoresho kugirango ubone ibisobanuro birambuye kuri runaka mask yo kubaga.
• Kubikoresho munsi ya Eua: Mugihe cyihutirwa, The Fda kubungabunga urutonde rwa bose Hishishijwe mbere yo kubaga n'abahutira ku rubuga rwayo. Uru rutonde rwerekanwe Abanyaristike yo kubaga barimo munsi ya Umbrella Eua for masike yo kubaga. Nubwo EUA irangira, ubu bubiko bukomeza kuba ingirakamaro.

Gukoresha ubwo buryo bwemewe nuburyo bwonyine bwindaro bwo kwemeza ko masike yo kubaga na N95 bahumeka Urimo kugura byemewe. Ibicuruzwa nkacu Ffp2 mask, mugihe uhuza ibipimo byu Burayi, byerekana ubwoko bwiza kandi gukanda imikorere iteganijwe kuva yemewe Ppe.

Ni ubuhe buryo bwa FDA nyuma yihutirwa kuri masike n'abahumanya?

Nka Impera zubuzima rusange, the Fda iragenda kure yo guhinduka kwa Euas no gusubira mubikorwa bisanzwe. Ikigo cyasohoye a Gahunda yinzibacyuho Ibikoresho byubuvuzi ibyo byari mbere byashyizweho mbere muri EUA. Ibi ubuyobozi vuga ingengabihe nibisabwa kubabikora masike yo kubaga nabahumanya gutanga gakondo Fda Gukuraho niba bashaka gukomeza kugurisha ibicuruzwa byabo muri U.S.

Ibi bivuze ko benshi muri mask na guhumeka Ibicuruzwa byagaragaye ku isoko mugihe icyorezo bizakenera kunyura mubikorwa 510 (k). Inzibacyuho ni ngombwa mugushimangira umutekano nubwiza bwa u.s. Ibikoresho byo Kurinda Umuntu. Kubashinzwe amasoko, bivuze ko uzakenera kuba umunyamwete mu kwemeza ko abaguzi bawe bakurikira ibi Gahunda yinzibacyuho Ibikoresho byubuvuzi kandi irashobora gutanga ibimenyetso byibizaza cyangwa bishya byakiriwe Fda kwemererwa kuri buri wese mask yo kubaga. Iranga gusubira mumahame yo hejuru asobanura Ibikoresho bigengwa na FDA.