FDA imayamba kuwunikanso momwe mtundu wa khungu umakhudzira zotsatira za pulse oximeter

Kumayambiriro kwa mliri wa COVID-19, chidwi cha ma pulse oximeter chidakwera.Chipangizocho chimawalitsa kuwala kwa chala kuti athe kuyerekeza kuchuluka kwa okosijeni m'magazi.Ogwiritsa amayang'ana zidazi kuti apeze njira yowonera momwe kachilombo ka corona kakukhudzidwira pamayendedwe opumira m'nyumba zawo ndikupeza ma data kuti apereke maziko opangira zisankho nthawi yopita kuchipatala.Zinapezeka kuti anthu ena omwe ali ndi mpweya wochepa wa okosijeni amapuma movutikira, zomwe zimawonjezera kufunika kwa deta.
Ma pulse oximeters ena amagulitsidwa ngati zinthu zathanzi, zamasewera kapena zowuluka munjira ya OTC.OTC oximeter siyoyenera kugwiritsidwa ntchito pachipatala ndipo sichinawunikidwenso ndi FDA.Ma pulse oximeters ena amatha kuyeretsedwa kudzera munjira ya 510 (k) ndipo atha kuperekedwa ndi mankhwala.Ogula omwe amawunika kuchuluka kwa okosijeni wawo nthawi zambiri amagwiritsa ntchito ma oximeter a OTC.
Kudetsa nkhawa za momwe khungu limakhudzira kulondola kwa ma pulse oximeters limatha kuyambira m'ma 1980.M'zaka za m'ma 1990, ofufuza adafalitsa maphunziro a dipatimenti yadzidzidzi ndi odwala omwe akudwala kwambiri ndipo sanapeze kugwirizana pakati pa khungu la pigmentation ndi zotsatira za pulse oximetry.Komabe, maphunziro oyambirira ndi amtsogolo adatulutsa deta yotsutsana.
COVID-19 komanso mesenjala waposachedwa wofalitsidwa mu New England Journal of Medicine abweretsanso mutuwu.Kalata yochokera ku NEJM inanena kuwunika komwe kunapeza kuti "odwala akuda amakhala ndi pafupifupi kuwirikiza katatu kwa hypoxemia yamatsenga mwa odwala oyera, ndipo ma pulse oximeter sangazindikire kuchuluka kwa izi."Kuphatikizapo Massachusetts D Senators kuphatikizapo Elizabeth Warren wa Misa adatchula deta ya NEJM mu kalata;mwezi watha adapempha FDA kuti iwunikenso za ulalo womwe ulipo pakati pa mtundu wa khungu ndi zotsatira za pulse oximeter.
M'chidziwitso chachitetezo Lachisanu, FDA idati ikuwunika zolembedwa zowona ngati ma pulse oximeters, "choyang'ana kwambiri ndikuwunika ngati anthu omwe ali ndi khungu lakuda ali ndi zolondola zazinthu."A FDA akuwunikanso zambiri zomwe zisanachitike msika ndikugwira ntchito ndi opanga kuti awunikenso umboni wina.Izi zitha kupangitsa kuti pakhale malangizo osinthidwa pamutuwu.Malangizo omwe alipo amalimbikitsa kuti osachepera awiri omwe ali ndi mtundu wakuda wakuda aphatikizidwa m'mayesero azachipatala a pulse oximeters.
Pakalipano, zochita za FDA zakhala zikungonena zonena za kugwiritsa ntchito moyenera ma pulse oximeters.The FDA Safety Newsletter ikufotokoza momwe mungapezere ndikutanthauzira zowerengedwa.Nthawi zambiri, ma pulse oximeters sakhala olondola pamilingo yotsika ya okosijeni wamagazi.A FDA adanena kuti kuwerenga kwa 90% kumatha kuwonetsa manambala enieni otsika mpaka 86% komanso okwera mpaka 94%.Mitundu yolondola ya OTC pulse oximeters yomwe siinawunikidwe ndi FDA ikhoza kukhala yotakata.
Makampani ambiri amapikisana pamsika wa prescription pulse oximeter.M'zaka zaposachedwa, makampani ambiri aku China adapeza ziphaso 510 (k) kuti agwirizane ndiukadaulo wina wamankhwala pamsika, monga Masimo ndi Smiths Medical.
Ndi kutchuka kwa ukadaulo ndi kugawana deta, chisamaliro chaumoyo chikhoza kusinthira ku zodziwikiratu, ndipo telemedicine idzayamba, zomwe zimapangitsa njira zatsopano zamankhwala.Izi zidzakakamiza makampani kuyika ndalama zambiri pachitetezo cha cyber.
Bungweli limayang'ana kwambiri zotsatira za kuphatikizika pamitengo.Njira yatsopanoyi ingapatsenso maziko ena azamalamulo okayikira mgwirizano.
Mitu yomwe ikukhudzidwa: kuphatikiza ndi kupeza, ukadaulo wazidziwitso zachipatala, ntchito zachipatala, mfundo zachipatala ndi malamulo, inshuwaransi yachipatala, machitidwe, ndi zina zambiri.
Ndi kutchuka kwa ukadaulo ndi kugawana deta, chisamaliro chaumoyo chikhoza kusinthira ku zodziwikiratu, ndipo telemedicine idzayamba, zomwe zimapangitsa njira zatsopano zamankhwala.Izi zidzakakamiza makampani kuyika ndalama zambiri pachitetezo cha cyber.
Bungweli limayang'ana kwambiri zotsatira za kuphatikizika pamitengo.Njira yatsopanoyi ingapatsenso maziko ena azamalamulo okayikira mgwirizano.
Mitu yomwe ikukhudzidwa: kuphatikiza ndi kupeza, ukadaulo wazidziwitso zachipatala, ntchito zachipatala, mfundo zachipatala ndi malamulo, inshuwaransi yachipatala, machitidwe, ndi zina zambiri.
Mitu yomwe ikukhudzidwa: kuphatikiza ndi kupeza, ukadaulo wazidziwitso zachipatala, ntchito zachipatala, mfundo zachipatala ndi malamulo, inshuwaransi yachipatala, machitidwe, ndi zina zambiri.