FDA inotanga kuongorora kuti ganda pigmentation rinokanganisa sei pulse oximeter mhinduro

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.Zvakaonekwa kuti vamwe vanhu vane yakaderera okisijeni mwero kufema, 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 Massachusetts D Senators kusanganisira Elizabeth Warren weMisa akataura NEJM data mutsamba;mwedzi wapera vakakumbira FDA kuti iongorore kubatana pakati peganda pigmentation uye pulse oximeter mhinduro.
Muchiziviso chekuchengetedza neChishanu, FDA yakataura kuti iri kuongorora zvinyorwa nezve pulse oximeters, "tariso iri pakuongorora kana vanhu vane ganda rakasviba vasina kunaka kwechigadzirwa."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 Safety Newsletter 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.
Nekuzivikanwa kwe tekinoroji uye kugovana data, hutano hunogona kuchinjika kune huwandu hwekufungidzira, uye telemedicine inokura, zvichikonzera nzira nyowani dzekurapa.Izvi zvinomanikidza makambani kuisa mari yakawanda mukuchengetedza cyber.
Sangano rinotarisa kukanganisa kwekubatana pamitengo.Iri zano idzva rinogona kupa humwe hwaro hwepamutemo hwekubvunzana kubatana.
Misoro inosanganisirwa: kubatanidzwa uye kutora, tekinoroji yeruzivo rwekurapa, masevhisi ekurapa, marongero ekurapa nemirairo, inishuwarenzi yekurapa, mashandiro, nezvimwe.
Nekuzivikanwa kwe tekinoroji uye kugovana data, hutano hunogona kuchinjika kune huwandu hwekufungidzira, uye telemedicine inokura, zvichikonzera nzira nyowani dzekurapa.Izvi zvinomanikidza makambani kuisa mari yakawanda mukuchengetedza cyber.
Sangano rinotarisa kukanganisa kwekubatana pamitengo.Iri zano idzva rinogona kupa humwe hwaro hwepamutemo hwekubvunzana kubatana.
Misoro inosanganisirwa: kubatanidzwa uye kutora, tekinoroji yeruzivo rwekurapa, masevhisi ekurapa, marongero ekurapa nemirairo, inishuwarenzi yekurapa, mashandiro, nezvimwe.
Misoro inosanganisirwa: kubatanidzwa uye kutora, tekinoroji yeruzivo rwekurapa, masevhisi ekurapa, marongero ekurapa nemirairo, inishuwarenzi yekurapa, mashandiro, nezvimwe.


Nguva yekutumira: Mar-10-2021