Hoʻomaka ka FDA e nānā i ka hopena o ka pigmentation ʻili i nā hopena o ka pulse oximeter

Ma kahi kamaʻilio palekana hou a ka Senatoa US e noi ana i ke keʻena e nānā i ka pololei o nā oximeters pulse, ua loiloi ka FDA i ka pololei o ke keʻena ma muli o nā hopohopo e pili ana i nā ʻokoʻa lāhui i nā ana oximeter pulse.
Ke ʻimi nei ka poʻe i nā ala e nānā ai i ko lākou kūlana hanu ma ka home e pili ana i ka hoʻoweliweli ʻia e ka maʻi maʻi coronavirus, ua hoʻohana nui ʻia nā pulse oximeters hiki ke kūʻai ʻia e like me nā lāʻau lapaʻau a me nā huahana over-the-counter.No ka manawa lōʻihi, ua hoʻonui kēia ʻano i nā hopohopo e pili ana i ka pilina ma waena o ka pigmentation ʻili a me nā hopena oximeter.
Ua pane ka FDA i kēia mau hopohopo ma ka hoʻomaopopo ʻana i nā mea maʻi a me nā mea mālama olakino i nā palena o ka hāmeʻa.Paipai ka ʻoihana i ka poʻe e nānā i nā loli i ko lākou pae oxygen i ka manawa, a e lawe i nā hōʻike ʻē aʻe ma waho o ka ʻikepili oximeter i ka wā e hoʻoholo ai.
I ka hoʻomaka ʻana o ka maʻi maʻi COVID-19, ua piʻi ka hoihoi i nā oximeters pulse.Hoʻomālamalama ka mea hana i ke kukui ma nā manamana lima e hoʻohālikelike i ka saturation oxygen i loko o ke koko.Ke ʻimi nei nā mea kūʻai aku i kēia mau mea e loaʻa ai kahi ala e loiloi ai i ka hopena o ka coronavirus ma ka ʻōnaehana hanu i ko lākou mau home a loaʻa i nā helu ʻikepili e hāʻawi i kumu no ka hoʻoholo ʻana i ka wā e ʻimi ai i nā lawelawe olakino.ʻO ka loaʻa ʻana o kekahi poʻe me ka haʻahaʻa o ka oxygen haʻahaʻa haʻahaʻa haʻahaʻa, e hoʻohui i ka waiwai o ka ʻikepili.
Kūʻai ʻia kekahi mau pulse oximeters e like me nā huahana olakino maʻamau, nā waiwai haʻuki a i ʻole nā ​​huahana mokulele ma ke ʻano o OTC.ʻAʻole kūpono ka oximeter OTC no ka hoʻohana olakino a ʻaʻole i loiloi ʻia e ka FDA.Hiki ke hoʻomaʻemaʻe ʻia nā oximeters pulse ʻē aʻe ma o ke ala 510 (k) a hiki ke hāʻawi ʻia me ka ʻōlelo kuhikuhi.Hoʻohana maʻamau nā mea hoʻohana e nānā i kā lākou pae oxygen i nā oximeter OTC.
Hiki ke ʻike ʻia nā hopohopo e pili ana i ka hopena o ka pigmentation ʻili i ka pololei o nā pulse oximeters i ka liʻiliʻi loa i ka makahiki 1980.I ka makahiki 1990, ua paʻi nā mea noiʻi i nā haʻawina o ka keʻena pilikia a me nā maʻi mālama koʻikoʻi a ʻaʻole i loaʻa kahi loulou ma waena o ka pigmentation ʻili a me nā hopena o ka pulse oximetry.Eia naʻe, ua hoʻopuka nā haʻawina mua a ma hope i nā ʻikepili kū'ē.
ʻO COVID-19 a me kahi ʻelele hou i paʻi ʻia ma ka New England Journal of Medicine ua hoʻihoʻi hou i kēia kumuhana.Ua hōʻike ʻia kahi leka mai NEJM i kahi loiloi i ʻike ʻia "ʻaneʻane ʻekolu manawa o ka poʻe maʻi ʻeleʻele i ka pinepine o ka hypoxemia occult i nā maʻi keʻokeʻo, a ʻaʻole hiki i nā oximeters pulse ke ʻike i kēia alapine."me Elizabeth Waugh Senators me Elizabeth Warren (D-Mass.) Ua haʻi aku i ka ʻikepili NEJM i kahi leka i ka mahina i hala e noi ana i ka FDA e nānā i ka loulou ma waena o ka pigmentation ʻili a me nā hopena o ka pulse oximeter.
Ma kahi hoʻolaha palekana ma ka Pōʻalima, ua ʻōlelo ka FDA e loiloi ana i ka palapala e pili ana i ka pololei o nā pulse oximeters, a "e nānā ana i ka loiloi ʻana i ka palapala e pili ana i ka poʻe me ka ʻili ʻeleʻele i ka pololei o ka huahana."Ke kālailai nei ka FDA i ka ʻikepili ma mua o ka mākeke a hana pū me nā mea hana e loiloi i nā hōʻike ʻē aʻe.Hiki i kēia kaʻina hana ke alakaʻi i nā alakaʻi i hoʻoponopono hou ʻia ma ke kumuhana.Manaʻo nā alakaʻi i kēia manawa e hoʻokomo ʻia ma kahi o ʻelua mau mea ʻeleʻele ʻeleʻele i loko o nā hoʻokolohua lapaʻau o nā pulse oximeters.
I kēia manawa, ua kaupalena ʻia nā hana a ka FDA i nā ʻōlelo e pili ana i ka hoʻohana pono ʻana i nā oximeters pulse.ʻO ka nūpepa palekana FDA e wehewehe i ka loaʻa a me ka wehewehe ʻana i nā heluhelu.ʻO ka maʻamau, ʻaʻole pololei ka pulse oximeters i nā pae haʻahaʻa o ka oxygen koko.Ua ʻōlelo ka FDA he 90% ka heluhelu e hōʻike ana i nā helu maoli e like me ka haʻahaʻa e like me ka 86% a me ke kiʻekiʻe o 94%.ʻOi aku paha ka laulā o ka pololei o ka OTC pulse oximeters i nānā ʻole ʻia e ka FDA.
Hoʻokūkū nā ʻoihana he nui i ka mākeke oximeter pulse prescription.I nā makahiki i hala iho nei, ua loaʻa i nā hui Kina he 510 (k) nā laikini e hui pū me nā ʻenehana lapaʻau ʻē aʻe ma ka mākeke, e like me Masimo a me Smiths Medical.
ʻO nā maʻi maʻi diabetes ʻo Dexcom lāua ʻo Insulet i wānana i ka ulu ʻana o ka ʻoihana o kēia makahiki a me ka hoʻonui ʻana i ka mākeke i kā lākou mau haʻiʻōlelo.
Me ke ala hou ʻana o ka coronavirus a me ka puka ʻana mai o nā maʻi lele, ʻo nā pilikia a me nā manawa kūpono e kū nei i mua o COVID-19 i mua o nā lāʻau lapaʻau a me nā ʻoihana diagnostic.
ʻO nā maʻi maʻi diabetes ʻo Dexcom lāua ʻo Insulet i wānana i ka ulu ʻana o ka ʻoihana o kēia makahiki a me ka hoʻonui ʻana i ka mākeke i kā lākou mau haʻiʻōlelo.
Me ke ala hou ʻana o ka coronavirus a me ka puka ʻana mai o nā maʻi lele, ʻo nā pilikia a me nā manawa kūpono e kū nei i mua o COVID-19 i mua o nā lāʻau lapaʻau a me nā ʻoihana diagnostic.