Thaum pib ntawm COVID-19 kev kis thoob qhov txhia chaw, kev txaus siab ntawm pulse oximeters tau nce.Cov cuab yeej ci ntsa iab ntawm lub teeb ntawm lub ntsis ntiv tes los kwv yees cov pa oxygen saturation hauv cov ntshav.Cov neeg tau txais kev pab nrhiav cov cuab yeej no kom tau txais ib txoj hauv kev los ntsuas qhov cuam tshuam ntawm tus kabmob coronavirus ntawm lub ntsws ua pa hauv lawv lub tsev thiab kom tau txais cov ntaub ntawv cov ntsiab lus los muab lub hauv paus rau kev txiav txim siab thaum mus nrhiav kev kho mob.Nws tau pom tias qee cov neeg uas muaj cov pa oxygen tsawg NW nyuam qhuav ua pa, uas ntxiv rau qhov muaj peev xwm ntawm cov ntaub ntawv.
Qee cov pulse oximeters raug muag raws li cov khoom siv kho mob, cov khoom siv ncaws pob lossis cov khoom siv dav hlau hauv daim ntawv OTC.OTC oximeter tsis haum rau kev siv kho mob thiab tsis tau tshuaj xyuas los ntawm FDA.Lwm cov pulse oximeters tuaj yeem raug tshem tawm los ntawm txoj kev 510 (k) thiab tuaj yeem muab nrog cov tshuaj.Cov neeg siv khoom uas saib xyuas lawv cov qib oxygen feem ntau siv OTC oximeters.
Kev txhawj xeeb txog cov nyhuv ntawm daim tawv nqaij pigmentation ntawm qhov tseeb ntawm pulse oximeters tuaj yeem taug qab mus rau tsawg kawg ntawm xyoo 1980.Hauv xyoo 1990, cov kws tshawb fawb tau luam tawm cov kev tshawb fawb ntawm lub chaw kho mob xwm txheej ceev thiab cov neeg mob hnyav thiab pom tias tsis muaj kev sib txuas ntawm daim tawv nqaij pigmentation thiab pulse oximetry cov txiaj ntsig.Txawm li cas los xij, kev tshawb fawb thaum ntxov thiab tom qab tau tsim cov ntaub ntawv tsis sib haum xeeb.
COVID-19 thiab tus xa xov tsis ntev los no tau luam tawm hauv New England Journal of Medicine tau coj cov ncauj lus no rov qab los ua qhov tseem ceeb.Ib tsab ntawv los ntawm NEJM qhia txog kev soj ntsuam uas pom tias "cov neeg mob dub muaj yuav luag peb npaug ntawm qhov zaus ntawm occult hypoxemia hauv cov neeg mob dawb, thiab pulse oximeters tsis tuaj yeem kuaj pom qhov zaus no."suav nrog Massachusetts D Senators suav nrog Elizabeth Warren ntawm pawg tau hais txog NEJM cov ntaub ntawv hauv tsab ntawv;Lub hli tas los lawv tau thov FDA los tshuaj xyuas qhov sib txuas ntawm daim tawv nqaij pigmentation thiab pulse oximeter cov txiaj ntsig.
Hauv tsab ntawv ceeb toom kev nyab xeeb rau hnub Friday, FDA tau hais tias nws tab tom ntsuas cov ntaub ntawv ntawm qhov raug ntawm pulse oximeters, "lub hom phiaj yog los tshuaj xyuas seb cov neeg uas muaj tawv nqaij tsaus muaj cov khoom tsis zoo."FDA kuj tseem tshuaj xyuas cov ntaub ntawv ua ntej kev ua lag luam thiab ua haujlwm nrog cov tuam txhab lag luam los ntsuas lwm cov pov thawj.Cov txheej txheem no tuaj yeem ua rau kev hloov kho cov lus qhia ntawm qhov kev kawm.Cov lus qhia uas twb muaj lawm pom zoo kom tsawg kawg ob tus neeg tuaj koom nrog cov xim tsaus nti nrog rau hauv kev sim tshuaj ntawm pulse oximeters.
Txog tam sim no, FDA qhov kev ua tau txwv rau cov lus hais txog kev siv cov pulse oximeters.Tsab ntawv xov xwm FDA Kev Nyab Xeeb piav qhia yuav ua li cas kom tau txais thiab txhais cov ntawv nyeem.Feem ntau, pulse oximeters tsis tshua muaj tseeb ntawm cov ntshav qis qis.FDA tau hais tias 90% kev nyeem ntawv tuaj yeem cuam tshuam cov lej tiag tiag tsawg li 86% thiab siab txog 94%.Qhov tseeb ntau yam ntawm OTC pulse oximeters uas tsis tau tshuaj xyuas los ntawm FDA yuav dav dua.
Kaum ob ntawm cov tuam txhab sib tw hauv kev lag luam pulse oximeter.Nyob rau hauv xyoo tas los no, ntau lub tuam txhab Suav tau txais 510 (k) cov ntawv tso cai los koom nrog lwm yam kev kho mob hauv khw, xws li Masimo thiab Smiths Medical.
Nrog rau kev siv thev naus laus zis thiab kev sib faib cov ntaub ntawv nrov, kev kho mob tuaj yeem hloov mus rau kev kwv yees ntau dua, thiab telemedicine yuav txhim kho, ua rau muaj kev kho mob tshiab.Qhov no yuav yuam cov tuam txhab lag luam los nqis peev ntau hauv cyber security.
Lub koom haum tsom mus rau qhov cuam tshuam ntawm kev sib koom ua ke ntawm cov nqi.Lub tswv yim tshiab no tuaj yeem muab lwm txoj hauv kev rau kev nug txog kev koom tes.
Cov ncauj lus koom nrog: kev sib koom ua ke thiab kev yuav khoom, kev kho mob cov ntaub ntawv thev naus laus zis, kev pabcuam kho mob, cov cai thiab cov cai, kev tuav pov hwm kho mob, kev ua haujlwm, thiab lwm yam.
Nrog rau kev siv thev naus laus zis thiab kev sib faib cov ntaub ntawv nrov, kev kho mob tuaj yeem hloov mus rau kev kwv yees ntau dua, thiab telemedicine yuav txhim kho, ua rau muaj kev kho mob tshiab.Qhov no yuav yuam cov tuam txhab lag luam los nqis peev ntau hauv cyber security.
Lub koom haum tsom mus rau qhov cuam tshuam ntawm kev sib koom ua ke ntawm cov nqi.Lub tswv yim tshiab no tuaj yeem muab lwm txoj hauv kev rau kev nug txog kev koom tes.
Cov ncauj lus koom nrog: kev sib koom ua ke thiab kev yuav khoom, kev kho mob cov ntaub ntawv thev naus laus zis, kev pabcuam kho mob, cov cai thiab cov cai, kev tuav pov hwm kho mob, kev ua haujlwm, thiab lwm yam.
Cov ncauj lus koom nrog: kev sib koom ua ke thiab kev yuav khoom, kev kho mob cov ntaub ntawv thev naus laus zis, kev pabcuam kho mob, cov cai thiab cov cai, kev tuav pov hwm kho mob, kev ua haujlwm, thiab lwm yam.
Post lub sij hawm: Mar-10-2021