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

Mukulankhulana kwaposachedwa kwachitetezo ndi Senator waku US kufunsa bungweli kuti liwunikenso kulondola kwa ma pulse oximeters, a FDA adawunikiranso kulondola kwa bungweli chifukwa chokhudzidwa ndi kusiyana kwamitundu komwe kungachitike mumiyeso ya pulse oximeter.
Pamene anthu afunafuna njira zowonera momwe akupumira kunyumba kutengera chiwopsezo cha mliri wa coronavirus, ma pulse oximeters omwe amatha kugulidwa ngati mankhwala olembedwa ndi mankhwala omwe akugwiritsidwa ntchito kwambiri.Kwa nthawi yayitali, izi zakulitsa nkhawa zokhudzana ndi ubale wamtundu wa khungu ndi zotsatira za oximeter.
A FDA adayankha ku nkhawazi podziwitsa odwala ndi othandizira azaumoyo za malire a chipangizocho.Bungweli limalimbikitsa anthu kuti azitsatira kusintha kwa mpweya wawo pakapita nthawi, komanso kuti aganizirenso umboni wina wosiyana ndi oximeter popanga zisankho.
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.Kupeza kuti anthu ena omwe ali ndi mpweya wochepa wa okosijeni amapuma movutikira, zomwe zimawonjezera kufunika kwa datayo.
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 Elizabeth Waugh Senators kuphatikizapo Elizabeth Warren (D-Mass.) adatchula deta ya NEJM m'kalata mwezi watha yopempha FDA kuti iwunikenso mgwirizano pakati pa khungu la khungu ndi zotsatira za pulse oximeter.
M'chidziwitso chachitetezo Lachisanu, FDA idati ikuwunika zolembedwa zowona ngati ma pulse oximeters, ndipo "imayang'ana pakuwunika zolemba 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.Kalata yachitetezo ya FDA imafotokoza momwe mungapezere ndikutanthauzira zowerengera.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.
Odwala matenda a shuga Dexcom ndi Insulet onse ananeneratu za kukula kwa bizinesi chaka chino komanso kukula kwa msika m'malankhulidwe awo.
Ndi kuuka kwa coronavirus komanso kutuluka kwa zovuta zopatsirana, zovuta ndi mwayi womwe COVID-19 ukukumana nawo zili patsogolo pazida zamankhwala ndi makampani ozindikira matenda.
Odwala matenda a shuga Dexcom ndi Insulet onse ananeneratu za kukula kwa bizinesi chaka chino komanso kukula kwa msika m'malankhulidwe awo.
Ndi kuuka kwa coronavirus komanso kutuluka kwa zovuta zopatsirana, zovuta ndi mwayi womwe COVID-19 ukukumana nawo zili patsogolo pazida zamankhwala ndi makampani ozindikira matenda.