NGAPHAMBILI: Amasu Okongiwa Kweshubhu Yegazi Lesampula Yegazi

I-US Food and Drug Administration (FDA) iyazi ukuthi i-United States ihlangabezana nokuphazamiseka okukhulu ekunikezelweni kwamashubhu esampula egazi (ukudonsa igazi) ngenxa yokwanda kwesidingo ngesikhathi sezimo eziphuthumayo ze-COVID-19 kanye nezinselelo zakamuva zokuhlinzekwa komthengisi. .I-FDA yandisa uhlu lokushoda kwemishini yezokwelapha ukuze lufake wonke amashubhu okuqoqwa kwesampula yegazi.I-FDA ngaphambilini yakhipha incwadi eya kubasebenzi bezempilo kanye naselabhorethri ngoJuni10, 2021, mayelana nokushoda kwamashubhu esampula egazi le-sodium citrate (phezulu eluhlaza okwesibhakabhaka).

Izincomo

I-FDA incoma abahlinzeki bezempilo, abaqondisi baselabhorethri, ama-phlebotomists, kanye nabanye abasebenzi bacabangele amasu alandelayo okonga ukuze kuncishiswe ukusetshenziswa kweshubhu lokuqoqwa kwegazi nokugcina izinga nokuphepha kokunakekelwa kwesiguli:

• Dweba kuphela imishanguzo yegazi ebhekwa njengedingekile ngokwezempilo. Yehlisa izivivinyo lapho uvakashela isiguli kanye nokuhlolwa kokungezwani nomzimba kuphela kulezo eziqondise ezifundeni zezifo ezithile noma lapho kuzoshintsha khona ukwelashwa kwesiguli.

• Susa ama-oda okuhlolwa ayimpinda ukuze ugweme ukudonsa igazi okungadingekile.

• Gwema ukuhlola njalo kakhulu noma wandise izikhawu zesikhathi phakathi kokuhlolwa noma nini lapho kunokwenzeka.

• Cabangela ukuhlola okungeziwe noma ukwabelana ngamasampula phakathi kweminyango yaselabhorethri uma izibonelo ezaqoqwa ngaphambilini zikhona.

• Uma udinga ishubhu lokulahla, sebenzisa uhlobo lweshubhu elinenani elikhulu elitholakala endaweni yakho.

• Cabangela iphuzu lokuhlola ukunakekelwa okungadingi ukusebenzisa amashubhu okuqoqa isifanekiso segazi (ukuhlolwa kokugeleza kwe-lateral).

Izenzo ze-FDA

Ngomhla ka-19 Januwari 2022, i-FDA ibuyekeze uhlu lokushoda kwemishini yezokwelapha ukuze lufake wonke amashubhu okuqoqa isifanekiso segazi (amakhodi omkhiqizo we-GIM ne-JKA).Isigaba 506J se-Federal Food, Drug, and Cosmetic Act (FD&C Act) sidinga i-FDA ukuthi igcine uhlu olutholakala esidlangalaleni, olusesikhathini samanje lwamadivayisi i-FDA enqume ukuthi ayashoda.

Ngaphambilini, ivuliwe:

• NgoJuni 10, 2021, i-FDA yengeze amashubhu e-sodium citrate (phezulu eluhlaza okwesibhakabhaka) ngaphansi kwamakhodi omkhiqizo afanayo (i-GIM ne-JKA) ohlwini lokushoda kwedivayisi yezokwelapha phakathi nesimo esiphuthumayo sezempilo somphakathi se-COVID-19.

• Ngomhla zingama-22 kuJulayi 2021, i-FDA ikhiphe Ukugunyazwa Kokusetshenziswa Kwezimo Eziphuthumayo ku-Becton Dickinson ngesampula yegazi elithile le-sodium citrate (phezulu okuluhlaza okwesibhakabhaka) asetshenziselwa ukuqoqa, ukuthutha, kanye nokugcina amasampula egazi ukuze kuhlolwe ukujiya ukuze kubonakale nokwelapha kangcono i-coagulopathy ezigulini. ne-COVID-19 eyaziwayo noma esolwayo.

I-FDA iyaqhubeka nokuqapha isimo samanje ukuze isize ukuqinisekisa ukuthi ukuhlolwa kwegazi kuhlala kutholakala ezigulini lapho ukuhlolwa kudingekile ngokwezokwelapha.I-FDA izokwazisa umphakathi uma ulwazi olusha olubalulekile lutholakala.