A cikin wata sadarwar aminci ta kwanan nan da Sanatan Amurka ya nemi hukumar ta sake duba sahihancin ma'aunin bugun jini, FDA ta sake duba sahihancin hukumar saboda damuwa game da yiwuwar bambance-bambancen kabilanci a ma'aunin bugun jini.
Kamar yadda mutane suka nemi hanyoyin sanya ido kan yanayin numfashinsu a gida dangane da barazanar da cutar sankara ke haifarwa, ana ƙara yin amfani da magungunan bugun jini da za'a iya siyan su azaman magungunan likitanci da samfuran kan layi.Na dogon lokaci, wannan yanayin ya kara damuwa game da dangantaka tsakanin pigmentation na fata da sakamakon oximeter.
FDA ta amsa waɗannan damuwar ta hanyar sanar da marasa lafiya da masu ba da lafiya iyakokin na'urar.Hukumar tana ƙarfafa mutane su bi diddigin canje-canjen matakan iskar oxygen ɗin su na tsawon lokaci, da kuma ɗaukar wasu shaidun ban da bayanan oximeter cikin la'akari yayin yanke shawara.
A farkon cutar ta COVID-19, sha'awar bugun jini ya karu.Na'urar tana haskaka hasken haske a kan yatsa don kimanta jikewar iskar oxygen a cikin jini.Masu cin kasuwa suna neman waɗannan na'urori don samun hanyar tantance tasirin coronavirus akan tsarin numfashi a cikin gidajensu da samun bayanan bayanai don samar da tushen yanke shawara lokacin neman sabis na likita.Binciken da aka gano cewa wasu mutanen da ke da karancin iskar oxygen da kyar suke shaka, wanda hakan ke kara samun kimar bayanan.
Ana sayar da wasu na'urorin bugun jini a matsayin samfuran kiwon lafiya na gabaɗaya, kayan wasa ko samfuran jirgin sama a cikin nau'in OTC.Oximeter na OTC bai dace da amfanin likita ba kuma FDA ba ta sake duba shi ba.Sauran bugun jini oximeters za a iya share ta hanyar 510 (k) hanya kuma za a iya bayar da tare da takardar sayan magani.Masu amfani waɗanda ke lura da matakan iskar su yawanci suna amfani da oximeters na OTC.
Damuwa game da tasirin launin fata akan daidaiton bugun jini oximeters ana iya gano su zuwa aƙalla shekarun 1980.A cikin 1990s, masu bincike sun buga nazarin sashen gaggawa da marasa lafiya masu kulawa kuma ba su sami wata alaƙa tsakanin launin fata da sakamakon oximetry na bugun jini.Duk da haka, binciken farko da na baya ya haifar da bayanai masu karo da juna.
COVID-19 da wani manzo kwanan nan da aka buga a cikin New England Journal of Medicine sun dawo da wannan batun cikin hankali.Wata wasiƙa daga NEJM ta ba da rahoton wani bincike wanda ya gano cewa "masu fama da baƙi suna da kusan sau uku yawan adadin hypoxemia na occult a cikin fararen marasa lafiya, kuma pulse oximeters ba za su iya gano wannan mitar ba."ciki har da Sanata Elizabeth Waugh ciki har da Elizabeth Warren (D-Mass.) Ya kawo bayanan NEJM a cikin wata wasiƙa a watan da ya gabata yana neman FDA ta sake nazarin haɗin tsakanin launin fata da sakamakon bugun jini.
A cikin sanarwar aminci a ranar Juma'a, FDA ta bayyana cewa tana kimanta wallafe-wallafen kan daidaiton ma'aunin bugun jini, kuma "ya mai da hankali kan kimanta wallafe-wallafen kan ko mutanen da ke da fata mai duhu ba su da daidaiton samfur."FDA kuma tana nazarin bayanan kafin kasuwa kuma tana aiki tare da masana'antun don kimanta wasu shaidu.Wannan tsari na iya haifar da sake fasalin jagororin kan batun.Sharuɗɗan da suka wanzu suna ba da shawarar cewa a haɗa aƙalla mahalarta masu launi biyu masu duhu a cikin gwajin asibiti na pulse oximeters.
Ya zuwa yanzu, ayyukan FDA sun iyakance ga bayanai game da yadda ya kamata amfani da bugun jini oximeters.Jaridar aminci ta FDA ta bayyana yadda ake samu da fassara karatu.Gabaɗaya, pulse oximeters ba su da inganci a ƙananan matakan oxygen na jini.FDA ta bayyana cewa karatun 90% na iya nuna ainihin lambobi kamar ƙasa da 86% kuma sama da 94%.Daidaitaccen kewayon OTC pulse oximeters waɗanda FDA ba ta yi nazari ba na iya zama mafi faɗi.
Kamfanoni da dama suna fafatawa a kasuwar pulse oximeter.A cikin 'yan shekarun nan, kamfanoni da yawa na kasar Sin sun sami lasisi 510 (k) don shiga wasu fasahohin likitanci a kasuwa, kamar Masimo da Smiths Medical.
Masu fama da ciwon sukari Dexcom da Insulet duk sun yi hasashen haɓakar kasuwancin bana da faɗaɗa kasuwa a cikin jawabansu.
Tare da tashin coronavirus da bullowar ƙarin nau'ikan cututtuka, ƙalubale da damar da COVID-19 ke fuskanta suna gaban na'urorin likitanci da kamfanonin bincike.
Masu fama da ciwon sukari Dexcom da Insulet duk sun yi hasashen haɓakar kasuwancin bana da faɗaɗa kasuwa a cikin jawabansu.
Tare da tashin coronavirus da bullowar ƙarin nau'ikan cututtuka, ƙalubale da damar da COVID-19 ke fuskanta suna gaban na'urorin likitanci da kamfanonin bincike.
Lokacin aikawa: Maris 15-2021