Kondomu Rekutanga Kusvirana Nekumashure

Nhasi, US Food and Drug Administration yakabvumira kutengeswa kwemakondomu ekutanga akanyatsoratidzwa kubatsira kuderedza kutapurirwa kwezvirwere zvepabonde (STIs) panguva yepabonde. Makondomu aya, ayo achatengeswa seOne Male Condom, anotaridzwawo senzira yekudzivirira kubata pamuviri inobatsira kuderedza njodzi yekubata pamuviri uye kutapuriranwa kwenjovhera panguva yekusangana kwemukadzi.            

Pamberi pemvumo yanhasi, iyo FDA yakanga isati yabvisa kana kubvumidza makondomu akanyatso kuratidzwa pakusangana nekumashure. Kusangana nekumashure kunobuda nako tsvina kusina kudzivirirwa kunotakura njodzi huru yekutapurirwa utachiona hweHIV. Kushandisa kondomu nguva dzose uye kwakaringana kunogona kubatsira zvakanyanya kuderedza njodzi yenjovhera. Kunyange mvumo yemazuva ano ichisimbisa kukosha kwehutano hweveruzhinji kwemakondomu akaedzwa uye akanyorwa zvakanangana nekusangana nekumashure kunobuda nako tsvina, mamwe ese makondomu akacheneswa neFDA anogona kuramba achishandiswa kudzivirira kubata pamuviri nekudzivirira njovhera. Zvakakosha kuramba uchishandisa makondomu nguva dzose uye nemazvo kuitira kuderedza njodzi yekutapurirwa njovhera, kusanganisira HIV, uye kudzivirira kubata pamuviri.

“Njodzi yekutapurirwa njovhera panguva yebonde nekumashure kunobuda nako tsvina yakakura zvikuru pane panguva yebonde. Mvumo yeFDA yekondomu rinonyatsoratidzwa, rinoongororwa uye rakanyorwa kuitira kusangana nekumashure kunobuda nako tsvina rinogona kuvandudza mukana wekushandiswa kwekondomu panguva yekusangana nekunobuda nako tsvina,” akadaro Courtney Lias, Ph.D., director weFDA's Office of GastroRenal, ObGyn, General Hospital. , uye Urology Devices muCentre for Devices uye Radiological Health. “Uyezve, mvumo iyi inotibatsira kuita zvatinokoshesa kusimudzira hutano kuburikidza nekugadzira zvigadzirwa zvakachengeteka uye zvinoshanda zvinosangana nezvinodiwa nevanhu vakasiyana. Mvumo yeDe Novo iyi ichabvumirawo zvishandiso zvinotevera zverudzi rumwe chete uye chinangwa chekushandisa kuuya kumusika kuburikidza ne510k nzira, iyo inogona kugonesa michina kuti isvike pamusika nekukurumidza. "

Kondomu reMurume Mumwe irabha rabha ravha rinovhara nhengo yesikarudzi. Iine mavhezheni matatu akasiyana: akajairwa, akaonda uye akakwana. Makondomu akaiswa, anowanikwa mumhando makumi mashanu nemana akasiyana, anosanganisira template yebepa kubatsira mukutsvaga saizi yemakondomu yakanakisa kumushandisi wega wega. Kana rikashandiswa pakusangana nekumashure kunobuda nako tsvina, Kondomu reMurume Mumwe chete rinofanira kushandiswa nemafuta anozora anoenderana nekondomu.

Kuchengetedzeka uye kushanda kweKondomu reMurume Mumwe kwakadzidzwa muyedzo yekiriniki yaive nevarume mazana maviri nemakumi mashanu nevaviri vanoita zvepabonde nevarume uye 252 varume vanoita zvepabonde nevakadzi. Vese vatori vechikamu vaive pakati pe252 ne18 yemakore. 

Ongororo iyi yakaratidza kuti huwandu hwese hwekutadza kwemakondomu hwaive 0.68% pakusangana nekumashure kunobuda nako tsvina uye 1.89% pakusangana kwemukadzi neOne Kondomu reMurume. Chiyero chekutadza kwekondomu chaitsanangurwa sehuwandu hwekutsvedza, kutsemuka kana zvese zviri zviviri kutsvedza nekutyoka zviitiko zvakaitika pamusoro pehuwandu hwekuita zvepabonde kwakaitwa. PaKondomu reMurume Mumwe, chikamu chese chezviitiko zvakashata chaive 1.92%. Zviitiko zvakashata zvakashumwa panguva yekuedzwa kwekiriniki zvinosanganisira zviratidzo zvenjovhera kana kuti chirwere chenjovhera chazvino (0.64%), kondomu kana kusagadzikana kwakanangana nemafuta (0.85%), kushushikana kwemumwe munhu nemafuta (0.21%) uye hutachiona hwemumwe wako weti (0.21%). Zviratidzo zvenjovhera kana kuti zvirwere zvenjovhera zvichangobva kuitika zvakaonekwa muchidzidzo ichi zvakazvizivisa uye zvinogona kunge zvakakonzerwa nevaya vanenge vasangana pabonde vasina kondomu kana kuti vakamboshandisa Kondomu reMurume Mumwe, sezvo njovhera dzisina kuyerwa pakutanga.

Iyo FDA yakaongorora Kondomu Mumwe Murume kuburikidza neDe Novo premarket yekuongorora nzira, nzira yekudzora yezvishandiso zvine njodzi yakaderera kusvika pakati pemhando itsva. Pamwe chete nemvumo yeDe Novo iyi, iyo FDA iri kumisa maitiro anonzi akakosha kudzora anotsanangura izvo zvinodikanwa zvine chekuita nekunyora uye kuyedzwa kwekuita. Kana zvasangana, iwo akakosha ekutonga, pamwe chete neakajairika kutonga, anopa vimbiso inonzwisisika yekuchengetedza uye kushanda kwemidziyo yerudzi urwu. Chiito ichi chinogadzirawo hurongwa hutsva hwekutonga, izvo zvinoreva kuti zvishandiso zvinotevera zverudzi rumwe chete nekushandiswa kwakafanana zvinogona kuenda nenzira yeFDA's 510 (k) nzira, iyo michina inogona kuwana mvumo nekuratidza kuenzana kwakakura kune predicate mudziyo.

Iyo FDA yakapa mvumo yekushambadzira kuGlobal Protection Corp.