Ikhondomu Lokuqala Lokuhlangana Endunu

Namuhla, i-US Food and Drug Administration igunyaze ukuthengiswa kwamakhondomu okuqala aboniswe ngokuqondile ukusiza ukunciphisa ukudluliswa kwezifo ezithathelwana ngocansi (STIs) ngesikhathi socansi lwendunu. La makhondomu azokhangiswa ngokuthi yi-One Male Condom, nawo akhonjiswe njengesivimbeli sokukhulelwa esiza ukwehlisa ubungozi bokukhulelwa kanye nokusulelana ngezifo zocansi ngesikhathi socansi.            

Ngaphambi kokugunyazwa kwanamuhla, i-FDA ibingakawasusi noma iwagunyazile amakhondomu akhonjiswe ucansi lwendunu. Ukuya ocansini kungavikelekile kuthwala ingozi enkulu yokuchayeka ngokocansi yokudlulisela i-HIV. Ukusebenzisa ikhondomu ngokungaguquki nokulungile kunamandla okusiza kakhulu ekwehliseni ingozi yezifo ezithathelwana ngocansi. Nakuba ukugunyazwa kwanamuhla kugcizelela ukubaluleka kwezempilo yomphakathi kwamakhondomu ahlolwe futhi alebulwe ngokuqondile ukuya ocansini lwendunu, wonke amanye amakhondomu asulwe yi-FDA angaqhubeka nokusetshenziselwa ukuvimbela inzalo kanye nokuvimbela i-STI. Kubalulekile ukuqhubeka nokusebenzisa amakhondomu ngokungaguquki nangendlela efanele ukuze kwehliswe ingozi yokutheleleka nge-STI, okuhlanganisa ne-HIV, nokuvimbela ukukhulelwa.

“Ingozi yokusulelana nge-STI ngesikhathi socansi lwangemuva iphezulu kakhulu kunangesikhathi socansi lwesitho sangasese sowesifazane. Ukugunyazwa yi-FDA kwekhondomu ekhonjiswe ngokuqondile, ehloliwe futhi efakwe ilebula yokuya ocansini ngendunu kungase kuthuthukise amathuba okusetshenziswa kwekhondomu ngesikhathi socansi ngendunu,” kusho u-Courtney Lias, Ph.D., umqondisi we-FDA's Office of GastroRenal, ObGyn, General Hospital. , kanye namadivayisi e-Urology esikhungweni samadivayisi kanye nempilo ye-Radiological. “Ngaphezu kwalokho, lesi sigunyazo sisisiza ukuthi sifeze okubalulekile kwethu ukuze sithuthukise ukulingana kwezempilo ngokwakha imikhiqizo ephephile nephumelelayo ehlangabezana nezidingo zabantu abahlukahlukene. Lokhu kugunyazwa kwe-De Novo kuzophinde kuvumele imishini elandelayo yohlobo olufanayo nokuhlosiwe ukuthi ize emakethe ngokusebenzisa indlela engu-510k, engenza amadivaysi ukuthi angene emakethe ngokushesha.”

I-One Male Condom iwushevu werabha we-latex wemvelo ovala umthondo. Inezinguqulo ezintathu ezahlukene: ejwayelekile, mncane futhi ifakwe. Amakhondomu afakiwe, atholakala ngosayizi abahlukene abangama-54, ahlanganisa isifanekiso sephepha ukusiza ekutholeni usayizi wekhondomu ongcono kakhulu kumsebenzisi ngamunye. Uma isetshenziswa ngesikhathi socansi lwendunu, Ikhondomu Yowesilisa Oyedwa kufanele isetshenziswe nesithambisi esihambisana nekhondomu.

Ukuphepha nokusebenza ngempumelelo kweKhondomu Yowesilisa Oyedwa kwacwaningwa ocwaningweni lomtholampilo olwakhiwe ngamadoda angama-252 aya ocansini namadoda kanye nama-252 amadoda aya ocansini nabesifazane. Bonke ababambiqhaza babephakathi kweminyaka eyi-18 kuye kwengama-54 ubudala. 

Ucwaningo luthole ukuthi izinga lokuhluleka kwekhondomu lilonke lalingu-0.68% ocansini lwendunu kanye no-1.89% ocansini lwesitho sangasese sowesifazane ngekhondomu Yendoda Eyedwa. Izinga lokwehluleka kwamakhondomu lichazwe njengenombolo yokushelela, ukuphuka noma kokubili izenzakalo ezishelelayo neziphukayo ezenzekile phezu kwenani eliphelele lezenzo zocansi ezenziwe. Kukhondomu Yowesilisa Oyedwa, amaphesenti esewonke ezigameko ezingezinhle abe ngu-1.92%. Izehlakalo ezimbi ezibikwe ngesikhathi sokuhlolwa komtholampilo zihlanganisa i-STI eyizimpawu noma ukuxilongwa kwakamuva kwe-STI (0.64%), ikhondomu noma ukungakhululeki okuhlobene nokugcotshwa (0.85%), ukungakhululeki kozakwethu nge-lubricant (0.21%) kanye nokutheleleka komgudu womchamo wozakwethu (0.21%). I-STI eyizimpawu noma ukuxilonga kwakamuva kwe-STI okubonwe ocwaningweni kuzibike ngokwazo futhi kungase kube umphumela wezifundo eziya ocansini ngaphandle kwekhondomu noma okungenzeka ukuthi zasebenzisa Ikhondomu Yowesilisa Oyedwa ngaphambilini, njengoba izifo zocansi zingakalwanga ekuqaleni.

I-FDA ibuyekeze Ikhondomu Yendoda Eyodwa ngokusebenzisa indlela yokubuyekeza imakethe yase-De Novo, indlela yokulawula yamadivayisi anobungozi obuncane ukuya kobumaphakathi bohlobo olusha. Ngokuhambisana nalokhu kugunyazwa kwe-De Novo, i-FDA isungula imibandela ebizwa ngokuthi izilawuli ezikhethekile ezichaza izidingo ezihlobene nokulebula nokuhlolwa kokusebenza. Uma kuhlangatshezwana nazo, izilawuli ezikhethekile, zihlangene nezilawuli ezijwayelekile, zinikeza isiqinisekiso esiphusile sokuphepha nokusebenza ngempumelelo kwamadivayisi alolu hlobo. Lesi senzo siphinde sidale ukuhlukaniswa kokulawula okusha, okusho ukuthi amadivayisi alandelayo ohlobo olufanayo anokusetshenziswa okufanayo okuhlosiwe angase adlule endleleni ye-FDA's 510(k), lapho amadivayisi angathola imvume ngokubonisa ukulingana okukhulu kudivayisi yesilandiso.

I-FDA inikeze igunya lokumaketha ku-Global Protection Corp.