Ekuqaleni kobhubhani we-COVID-19, umdla kwi-pulse oximeters wanda.Isixhobo sikhanyisa ukukhanya kwiincam zeminwe ukuqikelela ukugcwala kweoksijini egazini.Abathengi bajonga ezi zixhobo ukuze bafumane indlela yokuvavanya impembelelo ye-coronavirus kwinkqubo yokuphefumla kumakhaya abo kunye nokufumana amanqaku edatha ukubonelela ngesiseko sokwenza izigqibo ngexesha lokufuna iinkonzo zonyango.Kwafunyaniswa ukuba abanye abantu abanamaqondo aphantsi oksijini abaphefumli ngokulambisa, nto leyo esongeza kwixabiso elinokubakho ledatha.
Ezinye ii-pulse oximeters zithengiswa njengemveliso yezempilo jikelele, iimpahla zemidlalo okanye iimveliso zenqwelomoya ngohlobo lwe-OTC.I-oximeter ye-OTC ayifanelekanga ukusetyenziswa kwezonyango kwaye ayizange ihlaziywe yi-FDA.Ezinye ii-pulse oximeters zinokucocwa nge-510(k) indlela kwaye zinokubonelelwa ngomyalelo kagqirha.Abathengi abajonga amanqanaba abo e-oksijini badla ngokusebenzisa i-OTC oximeters.
Iinkxalabo malunga nefuthe le-pigmentation yesikhumba ekuchanekeni kwe-pulse oximeters inokulandelwa emva ubuncinane kwiminyaka yee-1980.Kwiminyaka yoo-1990, abaphandi bapapasha izifundo zesebe likaxakeka kunye nezigulana zokhathalelo olunzulu kwaye abafumananga nxibelelwano phakathi kwe-pigmentation yesikhumba kunye neziphumo ze-pulse oximetry.Nangona kunjalo, izifundo zangaphambili kunye nezamva zavelisa idatha ephikisanayo.
I-COVID-19 kunye nomthunywa wamva nje opapashwe kwiNew England Journal of Medicine ubuyisele esi sihloko kwingqwalasela.Ileta evela ku-NEJM inika ingxelo yohlalutyo olufumanise ukuba “abaguli abantsundu baphantse baphinda kathathu i-hypoxemia yobugqi kwizigulana ezimhlophe, kwaye ii-pulse oximeters azikwazi ukubona la maza.”Kubandakanya i-Senators ye-Massachusetts D kuquka u-Elizabeth Warren we-Mass ukhankanya idatha ye-NEJM kwileta;kwinyanga ephelileyo bacele i-FDA ukuba iphonononge ikhonkco phakathi kombala wesikhumba kunye neziphumo ze-pulse oximeter.
Kwisaziso sokhuseleko ngoLwesihlanu, i-FDA ithe ivavanya uncwadi malunga nokuchaneka kwe-pulse oximeters, "ugxininiso kukuvavanya ukuba ngaba abantu abanolusu olumnyama banemveliso engalunganga."I-FDA iphinda ihlalutye idatha yangaphambili kunye nokusebenza nabavelisi ukuvavanya obunye ubungqina.Le nkqubo inokukhokelela kwizikhokelo ezihlaziyiweyo kulo mbandela.Izikhokelo ezikhoyo zincoma ukuba ubuncinane ababini abathathi-nxaxheba abanombala omnyama bafakwe kwizilingo zeklinikhi ze-pulse oximeters.
Ukuza kuthi ga ngoku, izenzo ze-FDA zikhawulelwe kwiingxelo malunga nokusetyenziswa ngokufanelekileyo kwe-pulse oximeters.I-FDA Newsletter yoKhuseleko ichaza indlela yokufumana nokutolika ufundo.Ngokubanzi, i-pulse oximeters ayichanekanga kangako kumanqanaba asezantsi eoksijini yegazi.I-FDA ithe i-90% yokufunda ingabonisa amanani okwenene aphantsi njenge-86% kwaye aphezulu njenge-94%.Uluhlu oluchanekileyo lwe-OTC pulse oximeters olungakhange luhlaziywe yi-FDA lunokuba lubanzi.
Iinkampani ezininzi zikhuphisana kwimarike ye-oximeter ye-pulse pulse.Kwiminyaka yakutshanje, iinkampani ezininzi zaseTshayina zifumene iilayisensi ezingama-510(k) zokujoyina obunye ubuchwephesha bezonyango kwimarike, njengeMasimo kunye neSmiths Medical.
Ngokuthandwa kwethekhnoloji kunye nokwabelana ngedatha, ukhathalelo lwezempilo lunokutshintshela ekuqikelelekeni ngakumbi, kwaye i-telemedicine iya kuphuhliswa, okukhokelela kwiindlela ezintsha zonyango.Oku kuya kunyanzela iinkampani ukuba zityale imali ngakumbi kukhuseleko lwe-cyber.
I-arhente igxile kwimpembelelo yokudibanisa kumaxabiso.Esi sicwangciso sitsha sinokusinika esinye isiseko esisemthethweni sokubuza imibuzo yentsebenziswano.
Izihloko ezibandakanyekayo: ukudibanisa kunye nokufunyanwa, iteknoloji yolwazi lwezonyango, iinkonzo zonyango, imigaqo-nkqubo yezonyango kunye nemimiselo, i-inshurensi yonyango, imisebenzi, njl.
Ngokuthandwa kwethekhnoloji kunye nokwabelana ngedatha, ukhathalelo lwezempilo lunokutshintshela ekuqikelelekeni ngakumbi, kwaye i-telemedicine iya kuphuhliswa, okukhokelela kwiindlela ezintsha zonyango.Oku kuya kunyanzela iinkampani ukuba zityale imali ngakumbi kukhuseleko lwe-cyber.
I-arhente igxile kwimpembelelo yokudibanisa kumaxabiso.Esi sicwangciso sitsha sinokusinika esinye isiseko esisemthethweni sokubuza imibuzo yentsebenziswano.
Izihloko ezibandakanyekayo: ukudibanisa kunye nokufunyanwa, iteknoloji yolwazi lwezonyango, iinkonzo zonyango, imigaqo-nkqubo yezonyango kunye nemimiselo, i-inshurensi yonyango, imisebenzi, njl.
Izihloko ezibandakanyekayo: ukudibanisa kunye nokufunyanwa, iteknoloji yolwazi lwezonyango, iinkonzo zonyango, imigaqo-nkqubo yezonyango kunye nemimiselo, i-inshurensi yonyango, imisebenzi, njl.
Ixesha lokuposa: Mar-10-2021