Amerika FDA irasaba kwipimisha asibesitosi iteganijwe kwisiga irimo ifu ya talc

Ku ya 26 Ukuboza 2024, Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA) cyatanze icyifuzo cy’ingenzi gisaba abakora amavuta yo kwisiga gukora ibizamini bya asibesitosi byateganijwe kuri talc irimo ibicuruzwa hakurikijwe ibiteganywa n’amategeko agenga ivugurura ry’amavuta yo kwisiga 2022 (MoCRA). Iki cyifuzo kizagira ingaruka zikomeye ku nganda zo kwisiga, cyane cyane ku isoko yo kwisiga yo mu rwego rwo kwisiga.

Uburyo bwa FDA bwateganijwe bwo gutahura burimo ubwoko bubiri: microscopi yumucyo (PLM): ubu buryo bushobora gusesengura umubare munini wintangarugero no kumenya asibesitosi witegereje ibintu bya kristu ya optique (nk'ibara, amabara menshi, indangagaciro zivunika, birefringence, nibindi.) ) hamwe na morphologie. Ikwirakwizwa rya Electron Microscopi / Ingufu Zitandukanya Spectroscopy / Gutandukanya Electron Yatoranijwe (TEM / EDS / SAED): Ubu buryo bushobora kumenya fibre ntoya no kumenya asibesitosi ukoresheje isesengura ryibanze, imiterere ya kristu, hamwe na morphologie.

FDA yavuze ko guhuza ubu buryo bubiri bishobora kugabanya cyane kumenya asibesitosi. Nubwo PLM ifite ubunini buke, irashobora gusesengura umubare munini wintangarugero; Kandi TEM / EDS / SAED irashobora kumenya fibre nto. Ubwo buryo bubiri bwuzuzanya, butezimbere ubunyangamugayo no kumenya neza.

Icyifuzo cyibipimo ngenderwaho mpuzamahanga bihuye nibipimo mpuzamahanga. Umuryango w’ubumwe bw’ibihugu by’Uburayi, Kanada, n’Ubuyapani washyizeho amabwiriza akomeye kugira ngo ibicuruzwa bya talc bitarimo umwanda wa asibesitosi. Tekinike ya Microscopique nka PLM na TEM ikoreshwa henshi kwisi kugirango tumenye neza asibesitosi. Ibipimo bihuriweho ntabwo bifasha kurengera ubuzima bwabaguzi gusa, ahubwo binateza imbere ubucuruzi mpuzamahanga kandi byongera abaguzi icyizere mumutekano wibicuruzwa bya talc ku isi.

Icyifuzo cya FDA kivuga neza ko niba asibesitosi igaragaye mu mavuta yo kwisiga cyangwa talc ikoreshwa mu kwisiga, ibicuruzwa bizafatwa nk'ubusambanyi kandi binyuranyije n'amategeko agenga ibiryo, ibiyobyabwenge, no kwisiga. Aya mabwiriza atanga ishingiro ryumvikana ryubahiriza amategeko.

Intego nyamukuru yiki cyifuzo nukugabanya ibyago byo guhura nabaguzi kuri asibesitosi no kwirinda indwara zifitanye isano. Muri icyo gihe, bizafasha kandi ababikora kugabanya inshuro zo kwibuka ibicuruzwa no kugabanya ingaruka zikorwa.

Byongeye kandi, iki cyifuzo cyuzuza icyuho cyinshi mumabwiriza ya MoCRA, cyane cyane kubyerekeranye no kudasobanukirwa neza ibipimo byo gupima umutekano wo kwisiga byakozwe ninganda nto n'iziciriritse. Ubu FDA yasobanuye neza uburyo bwo gupima asibesitosi muri talc, itanga ubuyobozi busobanutse ku nganda.

FDA yafunguye igihe cyo gusuzuma mu ruhame kugira ngo abaturage babigizemo uruhare ndetse n’intambwe zizakurikiraho, itariki ntarengwa yo ku ya 27 Werurwe 2025.Ibi bitanga amahirwe ku nganda n’abaturage kugira uruhare mu bikorwa byo kugenzura. Niba amaherezo yarangiye, aya mabwiriza mashya azazamura cyane umutekano wa talc irimo kwisiga kandi bitange uburinzi bukomeye kubuzima bwabaguzi.

Icyifuzo cya FDA kigaragaza abayobozi bashinzwe kugenzura cyane cyane umutekano wo kwisiga, cyane cyane mu kumenya asibesitosi, kanseri izwi. Bitewe n'icyifuzo gishya cya FDA, Biro Veritas irasaba ko abakora amavuta yo kwisiga batangira gusuzuma no kuvugurura uburyo bwabo bwo kugenzura ubuziranenge hakiri kare, cyane cyane kubicuruzwa birimo talc. Ibigo bireba bigomba gushaka ubufasha ku gihe cy’ibindi bigo bishinzwe ibizamini, guhugura abakozi bireba, no gushyiraho uburyo bunoze bwo gucunga neza amasoko kugira ngo hubahirizwe ibisabwa bishya bigenga amategeko, bikomeze kumenyekanisha ibicuruzwa, kandi byizere abaguzi.

Laboratwari ya BTF, isosiyete yacu ifite laboratoire ihuza amashanyarazi, amabwiriza yumutekano Laboratoire, Laboratoire idafite radiyo Laboratoire, Laboratoire ya Batiri, Laboratoire y’imiti, Laboratoire ya SAR, Laboratoire ya HAC, nibindi. Twabonye impamyabumenyi nuburenganzira nka CMA, CNAS, CPSC, VCCI, n'ibindi Isosiyete yacu ifite itsinda ryubuhanga bwubuhanga kandi bwumwuga, rishobora gufasha ibigo gukemura ikibazo. Niba ufite ibizamini bikenewe hamwe nimpamyabushobozi, urashobora guhamagara abakozi bacu bipimisha kugirango ubone ibisobanuro birambuye hamwe nibisobanuro byamakuru!