FDA itangira gusuzuma uburyo pigmentation yuruhu igira ingaruka kuri pulse oximeter

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.Byagaragaye ko abantu bamwe bafite urugero rwa ogisijeni nkeya bahumeka neza, 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 ba Massachusetts D barimo Elizabeth Warren wa Mass bavuze amakuru ya NEJM mu ibaruwa;ukwezi gushize basabye FDA gusuzuma isano iri hagati yuruhu rwibara ryuruhu nibisubizo bya pulse oximeter.
Ku wa gatanu, mu itangazo ry’umutekano, FDA yavuze ko irimo gusuzuma ibitabo byerekeranye n’imyuka ya oxyde ya pulse, “icyibandwaho ni ugusuzuma 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 ka 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.
Hamwe nogukwirakwiza ikoranabuhanga no gusangira amakuru, ubuvuzi bushobora guhinduka muburyo buteganijwe, kandi telemedisine izatera imbere, bivamo uburyo bushya bwo kuvura.Ibi bizahatira ibigo gushora imari mumutekano wa cyber.
Ikigo cyibanze ku ngaruka zo guhuza ibiciro.Izi ngamba nshya zishobora kuyiha urundi rwego rwemewe rwo kubaza ubufatanye.
Ingingo zirimo: guhuza no kugura, ikoranabuhanga ryamakuru yubuvuzi, serivisi zubuvuzi, politiki yubuvuzi n’amabwiriza, ubwishingizi bwubuvuzi, ibikorwa, nibindi.
Hamwe nogukwirakwiza ikoranabuhanga no gusangira amakuru, ubuvuzi bushobora guhinduka muburyo buteganijwe, kandi telemedisine izatera imbere, bivamo uburyo bushya bwo kuvura.Ibi bizahatira ibigo gushora imari mumutekano wa cyber.
Ikigo cyibanze ku ngaruka zo guhuza ibiciro.Izi ngamba nshya zishobora kuyiha urundi rwego rwemewe rwo kubaza ubufatanye.
Ingingo zirimo: guhuza no kugura, ikoranabuhanga ryamakuru yubuvuzi, serivisi zubuvuzi, politiki yubuvuzi n’amabwiriza, ubwishingizi bwubuvuzi, ibikorwa, nibindi.
Ingingo zirimo: guhuza no kugura, ikoranabuhanga ryamakuru yubuvuzi, serivisi zubuvuzi, politiki yubuvuzi n’amabwiriza, ubwishingizi bwubuvuzi, ibikorwa, nibindi.


Igihe cyo kohereza: Werurwe-10-2021