FDA ceeb toom tias pulse oximeters yuav tsis raug rau cov neeg muaj xim

Lub pulse oximeter yog suav tias yog qhov tseem ceeb hauv kev tawm tsam COVID-19, thiab nws yuav tsis ua haujlwm raws li kev tshaj tawm los ntawm cov neeg muaj xim.
US Food and Drug Administration tau hais hauv tsab ntawv ceeb toom kev nyab xeeb tshaj tawm rau hnub Friday: "Lub cuab yeej tuaj yeem txo qhov raug rau cov neeg uas muaj xim tawv nqaij tsaus."
FDA cov lus ceeb toom muab ib qho yooj yim version ntawm kev kawm nyob rau hauv xyoo tas los no los yog txawm ob peb xyoos dhau los uas pom kev sib txawv ntawm haiv neeg nyob rau hauv kev ua tau zoo ntawm pulse oximeters, uas tuaj yeem ntsuas cov ntsiab lus oxygen.Clamp-type devices txuas nrog tib neeg cov ntiv tes thiab taug qab cov pa oxygen hauv lawv cov ntshav.Cov pa oxygen qis qis qhia tau tias cov neeg mob COVID-19 tuaj yeem mob hnyav dua.
FDA tau hais txog qhov kev tshawb fawb tsis ntev los no hauv nws cov lus ceeb toom uas pom tias cov neeg mob dub muaj ze li peb npaug ntau dua yuav muaj qhov txaus ntshai ntawm cov ntshav oxygen tsawg pom los ntawm pulse oximeters dua li cov neeg mob dawb.
Tsoomfwv Meskas Lub Chaw Tiv Thaiv thiab Tiv Thaiv Kab Mob kuj tau hloov kho nws cov lus qhia kho mob coronavirus kom ceeb toom cov kws kho mob ntawm cov kev tshawb fawb uas qhia tias cov tawv nqaij pigmentation tuaj yeem cuam tshuam qhov raug ntawm lub cuab yeej.
Qhov kev txav mus los ze li ib hlis tom qab peb tus neeg sawv cev hauv Asmeskas tau hu rau lub koom haum los tshuaj xyuas qhov tseeb ntawm cov khoom ntawm ntau haiv neeg.
"Muaj ntau qhov kev tshawb fawb tau ua nyob rau xyoo 2005, 2007, thiab tsis ntev los no xyoo 2020 tau pom tias pulse oximeters muab cov kev ntsuas ntshav oxygen tsis zoo rau cov neeg mob xim," Massachusetts Democrat Elizabeth Warren, New Jersey Sau Corey Booker ntawm Oregon thiab Ron Wyden ntawm Oregon..Lawv tau sau tias: "Tsuas muab tso, pulse oximeters zoo li muab cov cim qhia tsis tseeb ntawm cov ntshav oxygen qib rau cov neeg mob xim-xws li cov neeg mob noj qab haus huv dua li qhov lawv muaj tiag, thiab ua rau muaj kev pheej hmoo ntawm kev noj qab haus huv vim muaj kab mob xws li COVID-19.Kev pheej hmoo ntawm kev cuam tshuam tsis zoo. "
Cov kws tshawb fawb tau kwv yees xyoo 2007 tias feem ntau cov oximeters yuav raug ntsuas nrog cov neeg tawv nqaij, tab sis qhov tseeb yog tias cov xim ntawm daim tawv nqaij tsis tseem ceeb, thiab cov xim ntawm daim tawv nqaij yog ib qho tseem ceeb cuam tshuam nrog lub teeb liab infrared nqus hauv cov khoom nyeem.
Hauv kev kis tus kabmob coronavirus tshiab, qhov teebmeem no tseem cuam tshuam ntau dua.Ntau thiab ntau tus neeg yuav pulse oximeters siv hauv tsev, thiab cov kws kho mob thiab lwm tus kws kho mob siv lawv tom haujlwm.Tsis tas li ntawd, raws li CDC cov ntaub ntawv, cov neeg dub, Latinos, thiab Cov Neeg Qhab Asmeskas muaj feem yuav tau txais kev mus pw hauv tsev kho mob rau COVID-19 ntau dua li lwm tus.
PhD los ntawm University of Michigan Tsev Kawm Ntawv Tshuaj Kho Mob tau hais tias: "Vim tias muaj kev siv dav dav ntawm pulse oximetry hauv kev txiav txim siab kho mob, cov kev tshawb pom no muaj qee qhov cuam tshuam tseem ceeb, tshwj xeeb tshaj yog nyob rau lub sijhawm muaj tus kabmob coronavirus tam sim no."Michael Sjoding, Robert Dickson, Theodore Iwashyna, Steven Gay thiab Thomas Valley tau sau ib tsab ntawv mus rau New England Journal of Medicine nyob rau lub Kaum Ob Hlis.Lawv tau sau tias: "Peb qhov kev tshawb pom qhia tau hais tias kev cia siab rau ntawm pulse oximetry rau shunt cov neeg mob thiab kho cov pa oxygen ntxiv tuaj yeem ua rau muaj kev pheej hmoo ntawm hypoxemia lossis hypoxemia hauv cov neeg mob dub."
FDA tau liam tias qhov kev tshawb fawb tau txwv vim tias nws vam khom rau "cov ntaub ntawv sau tseg txog kev noj qab haus huv yav dhau los" hauv kev mus ntsib hauv tsev kho mob, uas tsis tuaj yeem kho cov lej rau lwm yam tseem ceeb.Nws tau hais tias: "Txawm li cas los xij, FDA pom zoo nrog cov kev tshawb pom no thiab hais txog qhov xav tau kev soj ntsuam ntxiv thiab kev nkag siab txog kev sib txuas ntawm daim tawv nqaij pigmentation thiab qhov tseeb ntawm oximeter."
FDA pom tias ntxiv rau cov xim ntawm cov tawv nqaij, cov ntshav tsis zoo, cov tawv nqaij tuab, cov tawv nqaij kub, haus luam yeeb thiab cov ntsia thawv polish, nws kuj cuam tshuam rau qhov tseeb ntawm cov khoom.
Cov ntaub ntawv lag luam muab los ntawm ICE cov ntaub ntawv kev pabcuam.ICE kev txwv.Txhawb thiab siv los ntawm FactSet.Xov xwm muab los ntawm Associated Press.Daim Ntawv Ceeb Toom.


Post lub sij hawm: Feb-25-2021