UHLAZIYO: Izicwangciso-qhinga zokuGcinwa kweMibhobho yoMfanekiso weGazi

I-US Food and Drug Administration (i-FDA) iyazi ukuba i-United States ifumana ukuphazamiseka okukhulu ekunikezelweni kweetyhubhu ezininzi zesampula yegazi (ukutsalwa kwegazi) ngenxa yokonyuka kwemfuno ngexesha likaxakeka le-COVID-19 yezempilo kunye nemingeni yamva nje yokubonelela ngabathengisi. .I-FDA yandisa uluhlu lokunqongophala kwezixhobo zonyango ukubandakanya zonke iityhubhu zokuqokelela isampuli yegazi.I-FDA ngaphambili yakhupha ileta eya kukhathalelo lwempilo kunye nabasebenzi baselabhoratri ngoJuni10, 2021, malunga nokunqongophala kwe-sodium citrate yokuqokelela isampula yegazi (iityhubhu eziluhlaza okwesibhakabhaka).

Iingcebiso

I-FDA icebisa ababoneleli bezempilo, abalawuli beelabhoratri, i-phlebotomists, kunye nabanye abasebenzi baqwalasele ezi zicwangciso zilandelayo zolondolozo ukunciphisa ukusetyenziswa kwetyhubhu yokuqokelela igazi kunye nokugcina umgangatho kunye nokhuseleko lokhathalelo lwesigulane:

• Yenza utsalo lwegazi kuphela oluthathwa njengoluyimfuneko ngokwezonyango. Nciphisa iimvavanyo kutyelelo lwempilontle kunye novavanyo lokwalana kuphela kwezo zijolise kwiindawo ezithile zesifo okanye apho ziya kutshintsha unyango lwesigulana.

• Susa iiodolo zovavanyo oluphindwe kabini ukunqanda ukutsalwa kwegazi ngokungeyomfuneko.

• Kulumkele ukuvavanywa rhoqo okanye wandise ixesha phakathi kovavanyo nanini na kunokwenzeka.

• Ukuqwalasela uvavanyo olongezelelekileyo okanye iisampulu zokwabelana phakathi kwamasebe elabhoratri ukuba iisampulu ebeziqokelelwe ngaphambili zikhona.

• Ukuba ufuna ityhubhu yokulahla, sebenzisa uhlobo lwetyhubhu enomthamo omkhulu okhoyo kwindawo yakho.

• Qwalasela inqaku lovavanyo lokhathalelo olungadingi ukuba kusetyenziswe iityhubhu zokuqokelela isampulu yegazi (iimvavanyo zokuqukuqela ecaleni).

Izenzo ze-FDA

NgoJanuwari 19, 2022, i-FDA yahlaziya uluhlu lokunqongophala kwezixhobo zonyango ukuze luquke zonke iityhubhu zokuqokelelwa kwesampuli yegazi (iikhowudi zemveliso zeGIM kunye ne-JKA).Icandelo 506J loMthetho we-Federal Food, Drug, and Cosmetic Act (FD & C Act) lifuna ukuba i-FDA igcine uluhlu olufumanekayo esidlangalaleni, oluhlaziyiweyo lwezixhobo i-FDA ezimisele ukuba zinqongophele.

Ngaphambili, ivuliwe:

• NgoJuni 10, 2021, i-FDA yongeza iityhubhu zesodium citrate (umphezulu oluhlaza okwesibhakabhaka) phantsi kweekhowudi zemveliso efanayo (GIM kunye ne-JKA) kuluhlu lokunqongophala kwezixhobo zonyango ngexesha likaxakeka lezempilo likarhulumente le-COVID-19.

• NgoJulayi 22, 2021, i-FDA ikhuphe isiGunyaziso sokuSetyenziswa okuNgxamisekileyo ku-Becton Dickinson kwisampula yegazi ye-sodium citrate (umphezulu oluhlaza okwesibhakabhaka) esetyenziselwa ukuqokelela, ukuthutha, kunye nokugcina iisampulu zegazi zovavanyo lwe-coagulation ukuchonga ngcono kunye nokunyanga i-coagulopathy kwizigulana. kunye ne-COVID-19 eyaziwayo okanye ekurhaneleka ngayo.

I-FDA iyaqhubeka nokubeka iliso kwimeko yangoku ukunceda ukuqinisekisa ukuba uvavanyo lwegazi luhlala lukhona kwizigulana apho uvavanyo luyimfuneko ngokwezonyango.I-FDA iya kwazisa uluntu ukuba ulwazi olutsha olubalulekileyo luyafumaneka.