I-FDA ilumkisa ukuba i-pulse oximeters isenokungachanekanga kubantu bemibala

I-pulse oximeter ithathwa njengebalulekile kumlo ochasene ne-COVID-19, kwaye isenokungasebenzi njengoko ibhengezwe ngabantu bemibala.
I-US Food and Drug Administration yathi kwisaziso sokhuseleko esikhutshwe ngoLwesihlanu: "Isixhobo sinokunciphisa ukuchaneka kwabantu abanebala elimnyama."
Isilumkiso se-FDA sibonelela ngoguqulelo olulula lophononongo kwiminyaka yakutshanje okanye kwiminyaka embalwa edlulileyo olufumene umahluko wobuhlanga ekusebenzeni kwe-pulse oximeters, enokulinganisa umxholo weoksijini.Izixhobo zohlobo lwe-Clamp zincanyathiselwe kwiminwe yabantu kwaye zilandelela ubungakanani beoksijini esegazini labo.Amanqanaba eoksijini asezantsi abonisa ukuba izigulana ze-COVID-19 zinokuba mandundu.
I-FDA icaphule uphononongo lwakutsha nje kwisilumkiso sayo esifumanise ukuba abaguli abantsundu baphantse baphindaphindeke kathathu ukuba babe namanqanaba asezantsi eoksijini egazi afunyenwe yi-pulse oximeters kunezigulana ezimhlophe.
Amaziko aseMelika oLawulo lweSifo kunye noThintelo nawo ahlaziye izikhokelo zeklinikhi ye-coronavirus ukukhumbuza iingcali zonyango ngezifundo ezibonisa ukuba umbala wolusu unokuchaphazela kakubi ukuchaneka kwesixhobo.
Eli nyathelo leza malunga nenyanga emva kokuba abameli abathathu base-US bacele le arhente ukuba iphonononge ukuchaneka kweemveliso zamaqela eentlanga ezahlukeneyo.
"Izifundo ezininzi eziqhutywe kwi-2005, i-2007, kwaye kutshanje kwi-2020 ibonise ukuba i-pulse oximeters ibonelela ngeendlela ezilahlekisayo zokulinganisa i-oxygen yegazi kwizigulane zombala," i-Massachusetts Democrat Elizabeth Warren, i-New Jersey Yabhala uCorey Booker wase-Oregon kunye noRon Wyden wase-Oregon..Babhale: “Ngokulula nje, i-pulse oximeters ibonakala ngathi ibonelela ngezalathisi ezilahlekisayo zamanqanaba eoksijini yegazi kwizigulana ezinemibala-ebonisa ukuba abaguli basempilweni kunokuba benjalo, kwaye zonyusa umngcipheko weengxaki zempilo ngenxa yezifo ezinjenge-COVID-19.Umngcipheko wempembelelo embi. "
Abaphandi baqikelela ngo-2007 ukuba uninzi lwee-oximeters zinokulinganiswa nabantu abanolusu olukhanyayo, kodwa isiseko sesokuba i-pigment yolusu ayibalulekanga, kwaye umbala wolusu yinto ebandakanyekayo ekufakweni kokukhanya okubomvu kwe-infrared ekufundweni kwemveliso.
Kubhubhani omtsha we-coronavirus, lo mbandela ubaluleke ngakumbi.Bayanda abantu abathenga i-pulse oximeters ukuba bayisebenzise ekhaya, kwaye oogqirha kunye nabanye abasebenzi bezempilo bayazisebenzisa emsebenzini.Ukongeza, ngokwedatha ye-CDC, abantu abamnyama, amaLatinos, kunye namaMelika aseMelika kunokwenzeka ukuba afumane ukulaliswa esibhedlele kwi-COVID-19 kunabanye.
I-PhD evela kwiYunivesithi yaseMichigan yeSikolo sezoNyango yathi: "Ngenxa yokusetyenziswa ngokubanzi kwe-pulse oximetry ekwenzeni izigqibo kwezonyango, ezi ziphumo zineziphumo ezibalulekileyo, ngakumbi ngeli xesha lesifo se-coronavirus."UMichael Sjoding, uRobert Dickson, uTheodore Iwashyna, uSteven Gay kunye noThomas Valley babhala ileta eya kwiNew England Journal of Medicine ngoDisemba.Babhala: "Iziphumo zethu zibonisa ukuba ukuthembela kwi-pulse oximetry ukukhupha izigulane kunye nokulungelelanisa amanqanaba e-oksijini eyongezelelweyo kunokunyusa umngcipheko we-hypoxemia okanye i-hypoxemia kwizigulana ezimnyama."
I-FDA yatyhola uphononongo ngokuba lulinganiselwe ngenxa yokuba luxhomekeke "kwidatha yerekhodi yezempilo eqokelelwe ngaphambili" kutyelelo lwesibhedlele, olungenakulungiswa ngokwezibalo kwezinye izinto ezinokuba zibalulekileyo.Yathi: “Noko ke, iFDA iyavumelana nezi zinto zifunyanisiweyo kwaye igxininisa imfuneko yovavanyo olungakumbi nokuqonda unxibelelwano phakathi kombala wolusu nokuchaneka kweoximeter.”
I-FDA yafumanisa ukuba ukongeza kumbala wolusu, ukungahambi kakuhle kwegazi, ukutyeba kwesikhumba, ubushushu bolusu, ukutshaya kunye nepolisi yeenzipho, kukwachaphazela ukuchaneka kwemveliso.
Idatha yemarike enikezelwe yinkonzo yedatha ye-ICE.Ukulinganiselwa kwe-ICE.Ixhaswa kwaye iphunyezwe yi-FactSet.Iindaba ezinikezelwe yiAssociated Press.Izaziso zoMthetho.


Ixesha lokuposa: Feb-25-2021