Engxoxweni yakamuva yezokuphepha eyenziwe nguSenatha wase-US ecela i-ejensi ukuthi ibuyekeze ukunemba kwama-pulse oximeters, i-FDA ibuyekeze ukunemba kwale nhlangano ngenxa yokukhathazeka mayelana nokwehluka okungaba khona kwezinhlanga ezilinganisweni ze-pulse oximeter.
Njengoba abantu befuna izindlela zokuqapha isimo sabo sokuphefumula ekhaya ngokususela ekusongelweni okubangelwa ubhubhane lwe-coronavirus, i-pulse oximeters engathengwa njengemithi kadokotela kanye nemikhiqizo ethengiswayo iya ngokuya isetshenziswa.Sekuyisikhathi eside, lo mkhuba ukhulise ukukhathazeka mayelana nobuhlobo phakathi kwe-pigmentation yesikhumba kanye nemiphumela ye-oximeter.
I-FDA iphendule kulokhu kukhathazeka ngokwazisa iziguli nabahlinzeki bezempilo mayelana nemikhawulo yedivayisi.I-ejensi ikhuthaza abantu ukuthi balandelele izinguquko emazingeni abo komoyampilo ngokuhamba kwesikhathi, futhi bacabangele obunye ubufakazi ngaphandle kwedatha ye-oximeter lapho benza izinqumo.
Ekuqaleni kobhubhane lwe-COVID-19, intshisekelo kuma-pulse oximeters yanda.Idivayisi ikhanyisa umsebe wokukhanya eminweni ukuze ulinganisele ukugcwala komoyampilo egazini.Abathengi bafuna le mishini ukuze bathole indlela yokuhlola umthelela we-coronavirus ohlelweni lokuphefumula ezindlini zabo futhi bathole amaphuzu edatha ukuze banikeze isisekelo sokuthatha izinqumo lapho bedinga usizo lwezokwelapha.Ukutholakala kokuthi abanye abantu abanamazinga komoyampilo aphansi abaphefumuli ngokulambisa, okwengeza inani elingaba khona ledatha.
Amanye ama-pulse oximeters athengiswa njengemikhiqizo yezempilo evamile, izimpahla zezemidlalo noma imikhiqizo yezindiza ngendlela ye-OTC.I-oximeter ye-OTC ayifanele ukusetshenziswa kwezokwelashwa futhi ayizange ibuyekezwe yi-FDA.Amanye ama-pulse oximeters angasulwa ngendlela engu-510(k) futhi anganikezwa nencwadi kadokotela.Abathengi abaqapha amazinga abo komoyampilo ngokuvamile basebenzisa ama-oximeter e-OTC.
Ukukhathazeka ngomphumela wokushintsha umbala kwesikhumba ekunembeni kwama-pulse oximeters kungalandelelwa emuva okungenani ngeminyaka yawo-1980.Ngawo-1990, abacwaningi bashicilela izifundo zomnyango wezimo eziphuthumayo kanye neziguli ezinakekela kakhulu futhi abatholanga ukuxhumana phakathi kwe-pigmentation yesikhumba kanye nemiphumela ye-pulse oximetry.Nokho, izifundo zakuqala nezakamuva zaveza idatha engqubuzanayo.
I-COVID-19 kanye nesithunywa sakamuva esishicilelwe ku-New England Journal of Medicine sibuyisele lesi sihloko ekugxileni kuso.Incwadi evela ku-NEJM ibika ngokuhlaziywa okutholwe ukuthi “iziguli ezimnyama zinemvamisa ephindwe kathathu ye-hypoxemia yemilingo ezigulini ezimhlophe, futhi ama-pulse oximeter awakwazi ukubona lokhu kuvame.”kuhlanganise no-Elizabeth Waugh Senators kuhlanganise no-Elizabeth Warren (D-Mass.) bacaphune idatha ye-NEJM encwadini ngenyanga edlule ecela i-FDA ukuthi ibuyekeze ukuxhumana phakathi kwe-pigmentation yesikhumba kanye nemiphumela ye-pulse oximeter.
Esazisweni sezokuphepha ngoLwesihlanu, i-FDA ithe ihlola izincwadi ngokunemba kwama-pulse oximeters, futhi "igxile ekuhloleni izincwadi ukuthi abantu abanesikhumba esimnyama banokunemba okungalungile komkhiqizo."I-FDA ibuye ihlaziye idatha yangaphambi kwemakethe futhi isebenzisane nabakhiqizi ukuze bahlole obunye ubufakazi.Le nqubo ingase iholele eziqondisweni ezibuyekeziwe ngesihloko.Imihlahlandlela ekhona incoma ukuthi okungenani ababambiqhaza ababili abanombala omnyama bafakwe ezivivinyweni zomtholampilo zama-pulse oximeters.
Kuze kube manje, izenzo ze-FDA zikhawulelwe ezitatimendeni eziphathelene nokusetshenziswa kahle kwama-pulse oximeters.Iphephabhuku lezokuphepha le-FDA lichaza ukuthi kutholakala kanjani futhi kuhunyushwe kanjani ukufundwa.Ngokuvamile, ama-pulse oximeters anembe kancane emazingeni aphansi komoyampilo wegazi.I-FDA ithe ukufunda okungama-90% kungase kubonise izinombolo zangempela eziphansi njenge-86% futhi ziphakame njenge-94%.Ibanga lokunemba lama-OTC pulse oximeters angazange abuyekezwe yi-FDA lingase libe banzi.
Izinkampani eziningi zincintisana emakethe ye-pulse oximeter ye-prescription.Eminyakeni yamuva, izinkampani eziningi zaseShayina zithole amalayisense angu-510(k) okujoyina obunye ubuchwepheshe bezokwelapha emakethe, obufana neMasimo kanye neSmiths Medical.
Iziguli ezinesifo sikashukela i-Dexcom ne-Insulet bobabili babikezele ukukhula kwebhizinisi kulo nyaka kanye nokwanda kwemakethe enkulumweni yabo.
Ngokuvuka kwe-coronavirus kanye nokuvela kwezinhlobo ezithathelwanayo, izinselele namathuba i-COVID-19 abhekene nayo aphambi kwemishini yezokwelapha nezinkampani zokuxilonga.
Iziguli ezinesifo sikashukela i-Dexcom ne-Insulet bobabili babikezele ukukhula kwebhizinisi kulo nyaka kanye nokwanda kwemakethe enkulumweni yabo.
Ngokuvuka kwe-coronavirus kanye nokuvela kwezinhlobo ezithathelwanayo, izinselele namathuba i-COVID-19 abhekene nayo aphambi kwemishini yezokwelapha nezinkampani zokuxilonga.
Isikhathi sokuthumela: Mar-15-2021