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.Kutholwe ukuthi abanye abantu abanamazinga e-oxygen 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.”Kuhlanganisa namaSenator aseMassachusetts D okuhlanganisa no-Elizabeth Warren weMisa acaphune idatha ye-NEJM encwadini;ngenyanga edlule bacele i-FDA ukuthi ibuyekeze ukuxhumana phakathi kwe-pigmentation yesikhumba kanye nemiphumela ye-pulse oximeter.
Esazisweni sezokuphepha sangoLwesihlanu, i-FDA ithe ihlola izincwadi ngokunemba kwama-pulse oximeters, "okugxilwe kakhulu ekuhloleni ukuthi abantu abanesikhumba esimnyama banokunemba okungalungile kwemikhiqizo."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.I-FDA Safety Newsletter ichaza indlela yokuthola nokuhumusha 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.
Ngokuthandwa kobuchwepheshe nokwabelana ngedatha, ukunakekelwa kwezempilo kungase kushintshele ekubikezelweni okwengeziwe, futhi i-telemedicine izothuthuka, okuholela ezindleleni zezokwelapha ezintsha.Lokhu kuzophoqa izinkampani ukuthi zitshale imali eningi kwezokuphepha ku-inthanethi.
I-ejensi igxile emthelela wokuhlanganisa ezintengo.Leli su elisha lingase linikeze esinye isisekelo esingokomthetho sokungabaza ukubambisana.
Izihloko ezihilelekile: ukuhlanganiswa nokutholwa, ubuchwepheshe bolwazi lwezokwelapha, izinsizakalo zezokwelapha, izinqubomgomo nemithetho yezokwelapha, umshwalense wezokwelapha, imisebenzi, njll.
Ngokuthandwa kobuchwepheshe nokwabelana ngedatha, ukunakekelwa kwezempilo kungase kushintshele ekubikezelweni okwengeziwe, futhi i-telemedicine izothuthuka, okuholela ezindleleni zezokwelapha ezintsha.Lokhu kuzophoqa izinkampani ukuthi zitshale imali eningi kwezokuphepha ku-inthanethi.
I-ejensi igxile emthelela wokuhlanganisa ezintengo.Leli su elisha lingase linikeze esinye isisekelo esingokomthetho sokungabaza ukubambisana.
Izihloko ezihilelekile: ukuhlanganiswa nokutholwa, ubuchwepheshe bolwazi lwezokwelapha, izinsizakalo zezokwelapha, izinqubomgomo nemithetho yezokwelapha, umshwalense wezokwelapha, imisebenzi, njll.
Izihloko ezihilelekile: ukuhlanganiswa nokutholwa, ubuchwepheshe bolwazi lwezokwelapha, izinsizakalo zezokwelapha, izinqubomgomo nemithetho yezokwelapha, umshwalense wezokwelapha, imisebenzi, njll.
Isikhathi sokuthumela: Mar-10-2021