FDA inotanga kuongorora kuti ganda pigmentation rinokanganisa sei pulse oximeter mhinduro

Mukukurukurirana kwekuchengetedza nguva pfupi yadarika kwakaitwa neSenata weUS achikumbira iyo agency kuti iongorore huchokwadi hwemapulse oximeters, FDA yakaongorora huchokwadi hwesangano iri nekuda kwekunetsekana kwekusiyana kwemadzinza mukuyera kwepulse oximeter.
Sezvo vanhu vakatsvaga nzira dzekutarisa mamiriro avo ekufema kumba zvichienderana nekutyisidzirwa nedenda rekoronavirus, pulse oximeters inogona kutengwa semishonga yemishonga uye zvigadzirwa zve-over-the-counter zviri kuwedzera kushandiswa.Kwenguva yakareba, maitiro aya akawedzera kushushikana nezvehukama pakati peganda pigmentation uye oximeter mhedzisiro.
Iyo FDA yakapindura kune izvi zvinonetsa nekuzivisa varwere nevarapi vehutano nezve zvipimo zvemudziyo.Sangano rinokurudzira vanhu kuti vatarise shanduko mumazinga eokisijeni nekufamba kwenguva, uye kutora humwe humbowo husiri hweoximeter data mukutarisisa pakuita sarudzo.
Pakutanga kweiyo COVID-19 denda, kufarira pulse oximeters kwakawedzera.Chishandiso chinovhenekera mwenje wechiedza pamunwe kufungidzira kuzara kweokisijeni muropa.Vatengi vanotsvaga michina iyi kuti vawane nzira yekuongorora maitiro eiyo coronavirus pamhepo yekufema mudzimba dzavo uye kuwana mapoinzi edata kuti vape hwaro hwekuita sarudzo nguva yekutsvaga rubatsiro rwekurapa.Kuwanikwa kwekuti vamwe vanhu vane yakaderera oksijeni mwero havafeme, izvo zvinowedzera kune inogona kukosha yedata.
Mamwe mapulse oximeter anotengeswa sezvigadzirwa zvehutano zvakajairika, zvemitambo kana zvigadzirwa zvemuchadenga muchimiro cheOTC.Iyo OTC oximeter haina kukodzera kushandiswa kwekurapa uye haina kuongororwa neFDA.Mamwe mapulse oximeter anogona kucheneswa kuburikidza ne510 (k) nzira uye anogona kupihwa nemishonga.Vatengi vanoongorora mazinga avo eokisijeni vanowanzo shandisa OTC oximeters.
Kunetsekana nezve mhedzisiro yeganda pigmentation pakurongeka kwepulse oximeters inogona kurondwa kumashure kusvika kuma1980s.Mumakore ekuma1990, vaongorori vakaburitsa zvidzidzo zvedhipatimendi rekukurumidzira uye varwere vakanyanya kuchengetedza uye havana kuwana chinongedzo pakati peganda pigmentation uye pulse oximetry zvawanikwa.Nekudaro, zvidzidzo zvekutanga uye zvepashure zvakaburitsa data inopokana.
COVID-19 uye mutumwa achangoburwa akaburitswa muNew England Journal of Medicine vadzosa nyaya iyi mukutarisa.Tsamba yakabva kuNEJM inoshuma ongororo yakawana kuti "varwere vatema vane kanenge katatu kuwanda kweoccult hypoxemia muvarwere vachena, uye pulse oximeter haigone kuona iyi frequency."kusanganisira Elizabeth Waugh Senators kusanganisira Elizabeth Warren (D-Mass.) akataura NEJM data mutsamba mwedzi wapera achikumbira FDA kuti iongorore kubatana pakati peganda pigmentation uye pulse oximeter zvawanikwa.
Muchiziviso chekuchengetedza neChishanu, FDA yakataura kuti iri kuongorora zvinyorwa nezve pulse oximeter, uye "inotarisa pakuongorora zvinyorwa zvekuti vanhu vane ganda rakasviba vane hurombo hwechigadzirwa."Iyo FDA iri kuongorora zvakare pre-musika data uye kushanda nevagadziri kuti vaongorore humwe humbowo.Iyi nzira inogona kutungamirira kune yakadzokororwa nhungamiro panyaya yacho.Nhungamiro iripo inokurudzira kuti vangangoita vaviri vatori vechikamu vane ruvara rwemavara vapinzwe mumakiriniki ekuyedzwa kwepulse oximeters.
Parizvino, zviito zveFDA zvakangogumira kune zvirevo zvine chekuita nekushandiswa kwakakodzera kwepulse oximeters.Iyo FDA kuchengetedza nhau inotsanangura nzira yekuwana nekududzira kuverenga.Kazhinji, pulse oximeters haina kunyatsojeka pamazinga eokisijeni eropa.Iyo FDA yakataura kuti kuverenga kwe90% kunogona kuratidza nhamba chaidzo dzakaderera se86% uye yakakwira se94%.Hwaro hwechokwadi hweOTC pulse oximeter isina kuongororwa neFDA inogona kunge yakakura.
Mazhinji emakambani anokwikwidza mumusika wekunyorerwa pulse oximeter.Mumakore achangopfuura, makambani mazhinji ekuChina akawana 510 (k) marezinesi ekubatanidza mamwe matekinoroji ekurapa pamusika, seMasimo uye Smiths Medical.
Varwere vane chirwere cheshuga Dexcom uye Insulet vese vakafungidzira kukura kwebhizinesi regore rino uye kuwedzera kwemusika mukutaura kwavo.
Nekumutswa kwekoronavirus uye nekubuda kwemamwe matambudziko anotapukira, matambudziko nemikana yakatarisana neCCIDID-19 iri pamberi pezvigadzirwa zvekurapa nemakambani ekuongorora.
Varwere vane chirwere cheshuga Dexcom uye Insulet vese vakafungidzira kukura kwebhizinesi regore rino uye kuwedzera kwemusika mukutaura kwavo.
Nekumutswa kwekoronavirus uye nekubuda kwemamwe matambudziko anotapukira, matambudziko nemikana yakatarisana neCCIDID-19 iri pamberi pezvigadzirwa zvekurapa nemakambani ekuongorora.