Kunxibelelwano lwakutsha nje lokhuseleko nguSenator wase-US ecela i-arhente ukuba iphonononge ukuchaneka kwe-pulse oximeters, i-FDA iphonononge ukuchaneka kwe-arhente ngenxa yeenkxalabo malunga nokungafani kobuhlanga obunokwenzeka kwimilinganiselo ye-pulse oximeter.
Njengoko abantu baye bafuna iindlela zokujonga imeko yabo yokuphefumla ekhaya ngokusekwe kwisoyikiso esibangelwa sisifo se-coronavirus, i-pulse oximeters enokuthengwa njengamayeza kagqirha kunye neemveliso ezithengiswayo ziya zisanda ukusetyenziswa.Kwangexesha elide, lo mkhwa uye wandisa inkxalabo malunga nobudlelwane phakathi kwe-pigmentation yesikhumba kunye neziphumo ze-oximeter.
I-FDA iphendule kwezi nkxalabo ngokwazisa izigulane kunye nababoneleli bezempilo ngokulinganiselwa kwesixhobo.I-arhente ikhuthaza abantu ukuba balandele utshintsho kumanqanaba abo oksijini ngokuhamba kwexesha, kwaye bathathe obunye ubungqina ngaphandle kwedatha ye-oximeter xa besenza izigqibo.
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.Ukufunyaniswa ukuba abanye abantu abanamanqanaba asezantsi eoksijini abaphefumli, 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.”kuquka u-Elizabeth Waugh Senators kuquka u-Elizabeth Warren (D-Mass.) Ukhankanya idatha ye-NEJM kwileta kwinyanga ephelileyo ecela i-FDA ukuba ihlolisise ikhonkco phakathi kwe-pigmentation yesikhumba kunye neziphumo ze-pulse oximeter.
Kwisaziso sokhuseleko ngoLwesihlanu, i-FDA ithe ivavanya uncwadi malunga nokuchaneka kwe-pulse oximeters, kwaye "igxile ekuvavanyeni uncwadi malunga nokuba abantu abanolusu olumnyama banokuchaneka kwemveliso."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.Incwadana yeendaba yokhuseleko ye-FDA 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.
Izigulana zesifo seswekile iDexcom kunye ne-Insulet bobabini baqikelele ukukhula kweshishini kulo nyaka kunye nokwandiswa kwentengiso kwiintetho zabo.
Ngokuvuka kwe-coronavirus kunye nokuvela kweentlobo ezosulelayo ngakumbi, imiceli mngeni kunye namathuba ajongene ne-COVID-19 aphambi kwezixhobo zonyango kunye neenkampani zokuxilonga.
Izigulana zesifo seswekile iDexcom kunye ne-Insulet bobabini baqikelele ukukhula kweshishini kulo nyaka kunye nokwandiswa kwentengiso kwiintetho zabo.
Ngokuvuka kwe-coronavirus kunye nokuvela kweentlobo ezosulelayo ngakumbi, imiceli mngeni kunye namathuba ajongene ne-COVID-19 aphambi kwezixhobo zonyango kunye neenkampani zokuxilonga.
Ixesha lokuposa: Mar-15-2021