FDA itangira gusuzuma uburyo pigmentation yuruhu igira ingaruka kuri pulse oximeter

Mu itumanaho ry’umutekano riherutse gukorwa n’Umusenateri w’Amerika asaba iki kigo gusuzuma niba impiswi za oxyde zuzuye, FDA yasuzumye ukuri kw’ikigo kubera impungenge z’uko hashobora kubaho itandukaniro rishingiye ku moko mu gupima oximeter.
Mu gihe abantu bashakishaga uburyo bwo gukurikirana uko bahumeka mu rugo hashingiwe ku iterabwoba ryatewe n'icyorezo cya coronavirus, impiswi ya pulse ishobora kugurwa nk'imiti yandikiwe n'ibicuruzwa birenga ibicuruzwa.Kuva kera, iyi myumvire yakajije umurego kubyerekeye isano iri hagati yuruhu rwibisubizo hamwe n ibisubizo bya oximeter.
FDA yashubije ibyo bibazo imenyesha abarwayi n'abashinzwe ubuvuzi aho ubushobozi bwabo bugarukira.Ikigo gishishikariza abantu gukurikirana impinduka ziterwa na ogisijeni mugihe, no gufata ibindi bimenyetso bitari imibare ya oximeter mugihe bafata ibyemezo.
Mu ntangiriro y’icyorezo cya COVID-19, inyungu za oxyde ya pulse ziyongereye.Igikoresho kimurika urumuri ku rutoki kugirango ugereranye umwuka wa ogisijeni uri mu maraso.Abaguzi bashakisha ibyo bikoresho kugirango babone uburyo bwo gusuzuma ingaruka za coronavirus kuri sisitemu yubuhumekero mu ngo zabo no kubona amanota yamakuru kugirango batange umusingi wo gufata ibyemezo mugihe bashaka serivisi zubuvuzi.Ubuvumbuzi ko abantu bamwe bafite urugero rwa ogisijeni nkeya bahumeka gake, ibyo bikaba byongerera agaciro agaciro kamakuru.
Oxymeter zimwe zigurishwa nkibicuruzwa byubuzima rusange, ibicuruzwa bya siporo cyangwa ibicuruzwa byindege muburyo bwa OTC.Oximeter ya OTC ntabwo ikwiriye gukoreshwa mubuvuzi kandi ntabwo yasuzumwe na FDA.Ubundi impiswi ya okisimetero irashobora guhanagurwa binyuze mumihanda 510 (k) kandi irashobora gutangwa hamwe na progaramu.Abaguzi bakurikirana urugero rwa ogisijeni bakunze gukoresha OTC oximeter.
Impungenge zijyanye n'ingaruka za pigmentation y'uruhu ku kuri kwa okisimetero ya pulse irashobora kuva mu myaka ya za 1980.Mu myaka ya za 90, abashakashatsi basohoye ubushakashatsi bw’ishami ryihutirwa n’abarwayi b’ubuvuzi bukomeye basanga nta sano riri hagati y’ibara ry’uruhu n’ibisubizo bya pulse oximetry.Nyamara, ubushakashatsi bwambere na nyuma bwatanze amakuru avuguruzanya.
COVID-19 hamwe nintumwa iherutse gusohoka mu kinyamakuru cyitwa New England Journal of Medicine yagaruye iyi ngingo.Ibaruwa ya NEJM ivuga isesengura ryerekanye ko “abarwayi b'abirabura bafite inshuro zigera kuri eshatu inshuro nyinshi hypoxemia yo mu bwoko bw'abapfumu ku barwayi bera, kandi oximeter ya pulse ntishobora kumenya iyi radiyo.”harimo Abasenateri Elizabeth Waugh barimo Elizabeth Warren (D-Mass.) bavuze amakuru ya NEJM mu ibaruwa yanditse mu kwezi gushize basaba FDA gusuzuma isano iri hagati y’ibara ry’uruhu n’ibisubizo bya oxyde.
Ku wa gatanu, mu itangazo ry’umutekano, FDA yavuze ko irimo gusuzuma ibitabo byerekeranye n’ukuri kwa oxyde ya pulse, kandi “yibanda ku gusuzuma ibitabo byerekana niba abantu bafite uruhu rwijimye bafite ibicuruzwa bidahwitse.”FDA kandi isesengura amakuru yabanjirije isoko kandi ikorana nabayikora kugirango basuzume ibindi bimenyetso.Iyi nzira irashobora kuganisha kumabwiriza yavuguruwe kuriyi ngingo.Amabwiriza ariho arasaba ko byibuze abitabiriye amahugurwa abiri yijimye bashyirwa mubigeragezo byamavuriro ya oxyde.
Kugeza ubu, ibikorwa bya FDA byagarukiye gusa ku magambo yerekeranye no gukoresha neza oximeter.Akanyamakuru k'umutekano FDA gasobanura uburyo bwo kubona no gusobanura ibyasomwe.Mubisanzwe, impiswi ya oxyde ntisobanutse neza kurwego rwa ogisijeni nkeya.FDA yavuze ko gusoma 90% bishobora kwerekana imibare nyayo iri munsi ya 86% naho hejuru ya 94%.Urutonde rwukuri rwa OTC pulse oximeter itarasuzumwe na FDA irashobora kuba yagutse.
Ibigo byinshi birushanwe kumasoko ya pulse oximeter.Mu myaka yashize, amasosiyete menshi yo mu Bushinwa yabonye impushya 510 (k) zo kwinjira mu bundi buhanga bw’ubuvuzi ku isoko, nka Masimo na Smiths Medical.
Abarwayi ba diyabete Dexcom na Insulet bombi bahanuye ko uyu mwaka izamuka ry’ubucuruzi no kwaguka ku isoko muri disikuru zabo.
Hamwe n'izuka rya coronavirus no kuvuka kwinshi kwanduye, ibibazo n'amahirwe COVID-19 ihura nabyo biri imbere yibikoresho byubuvuzi hamwe n’amasosiyete asuzuma.
Abarwayi ba diyabete Dexcom na Insulet bombi bahanuye ko uyu mwaka izamuka ry’ubucuruzi no kwaguka ku isoko muri disikuru zabo.
Hamwe n'izuka rya coronavirus no kuvuka kwinshi kwanduye, ibibazo n'amahirwe COVID-19 ihura nabyo biri imbere yibikoresho byubuvuzi hamwe n’amasosiyete asuzuma.