I kēia lā, ua ʻae ka US Food and Drug Administration i ke kūʻai aku ʻana i nā condom mua i kuhikuhi pono ʻia e kōkua i ka hōʻemi ʻana i ka lawe ʻana i nā maʻi i hoʻouna ʻia i ka moekolohe (STI) i ka wā o ka moekolohe. ʻO nā condom, e kūʻai ʻia ana ma ke ʻano he One Male Condom, ua hōʻike pū ʻia ma ke ʻano he contraceptive e kōkua i ka hōʻemi ʻana i ka pilikia o ka hāpai ʻana a me ka lawe ʻana i nā STI i ka wā o ka moekolohe.
Ma mua o ka ʻae ʻia ʻana o kēia lā, ʻaʻole i hoʻomaʻemaʻe a ʻae ʻia nā condoms i hōʻike ʻia no ka moe anal. ʻO ka hoʻopaʻa ʻole ʻia ʻana o ka anal ka mea e loaʻa ai ka maʻi HIV. ʻO ka hoʻohana ʻana i ka condom kūpaʻa a pololei ka mea hiki ke kōkua nui i ka hōʻemi ʻana i ka pilikia o nā STI. ʻOiai ʻo ka mana o kēia lā e hōʻike ana i ke koʻikoʻi o ke olakino lehulehu o nā condoms i hoʻāʻo ʻia a hoʻopaʻa inoa ʻia no ka moekolohe ʻana, hiki ke hoʻohana ʻia nā condom ʻē aʻe a pau i hoʻomaʻemaʻe ʻia e FDA no ka pale ʻana a me ka pale STI. He mea nui e hoʻomau i ka hoʻohana ʻana i ka condom me ka pololei a me ka hoʻohaʻahaʻa ʻana i ka pilikia o ka maʻi STI, me ka maʻi HIV, a me ka pale ʻana i ka hāpai ʻana.
ʻOi aku ka kiʻekiʻe o ka loaʻa ʻana o ka STI i ka wā o ka moekolohe ʻana ma mua o ka wā o ka moekolohe. ʻO ka ʻae ʻana a ka FDA i kahi condom i hōʻike pono ʻia, loiloi ʻia a hoʻopaʻa inoa ʻia no ka moekolohe ʻana e hiki ke hoʻomaikaʻi i ka likelike o ka hoʻohana ʻana i ka condom i ka wā o ka moekolohe ʻana, "wahi a Courtney Lias, Ph.D., ka luna o ka FDA's Office of GastroRenal, ObGyn, General Hospital. , a me nā mea Urology i ke kikowaena no nā mea hana a me ke olakino Radiological. "Eia kekahi, kōkua kēia ʻae iā mākou e hoʻokō i kā mākou mea nui e holomua i ke kaulike olakino ma o ka hoʻomohala ʻana i nā huahana palekana a maikaʻi hoʻi e kū ana i nā pono o nā lāhui like ʻole. E ʻae kēia ʻae ʻia ʻo De Novo i nā mea like o ke ʻano like a me ka hoʻohana ʻana e hele mai i ka mākeke ma o ke ala 510k, e hiki ai i nā mea hana ke hele wikiwiki i ka mākeke.
ʻO ka One Male Condom he puʻu latex maoli e uhi ana i ka penis. Loaʻa iā ia ʻekolu mau ʻano like ʻole: maʻamau, lahilahi a kūpono. ʻO nā condom i hoʻopaʻa ʻia, loaʻa i nā ʻano nui like ʻole 54, e hoʻokomo i kahi hoʻohālike pepa e kōkua ai i ka ʻimi ʻana i ka nui condom maikaʻi loa no kēlā me kēia mea hoʻohana. Ke hoʻohana ʻia i ka wā moe anal, pono e hoʻohana ʻia ka Condom Hoʻokahi kāne me kahi lubricant kūpono i ka condom.
Ua aʻo ʻia ka palekana a me ka maikaʻi o ka One Male Condom ma kahi hoʻokolohua lapaʻau i loaʻa i nā kāne 252 i moe me nā kāne a me 252 mau kāne i moe me nā wahine. ʻO nā mea komo a pau ma waena o 18 a 54 mau makahiki.
Ua ʻike ʻia ka haʻawina he 0.68% ka nui o ka hāʻule ʻana o ka condom no ka moe anal a me 1.89% no ka moekolohe ʻana me ka Condom One Male. Ua wehewehe ʻia ka helu hāʻule ʻana o ka condom e like me ka helu o ka paheʻe ʻana, ka haki ʻana a i ʻole nā hanana paheʻe ʻelua a me ka haki ʻana i hana ʻia ma luna o ka huina o nā moe kolohe i hana ʻia. No ka Condom kāne hoʻokahi, ʻo ka pākēneka o nā hanana ʻino he 1.92%. ʻO nā hanana pōʻino i hōʻike ʻia i ka wā o ka hoʻokolohua lapaʻau e pili ana i ka hōʻailona STI a i ʻole ka hōʻailona STI hou (0.64%), ka condom a i ʻole ka ʻeha pili i ka lubricant (0.85%), ka hōʻoluʻolu o ka hoa me ka lubricant (0.21%) a me ka maʻi urinary tract (0.21%). ʻO nā hōʻailona STI a i ʻole nā hōʻailona STI hou i ʻike ʻia i loko o ke aʻo ʻana ua hōʻike ponoʻī ʻia a ʻo ia paha ka hopena o nā kumuhana i pili me ka ʻole o ka condom a i ʻole ma mua o ka hoʻohana ʻana i ka One Male Condom, no ka mea ʻaʻole i ana ʻia nā STI ma ke kumu.
Ua nānā ka FDA i ka One Male Condom ma o ka De Novo premarket review pathway, he ala hoʻoponopono no nā mea haʻahaʻa a haʻahaʻa-pilikia o kahi ʻano hou. Me kēia ʻae ʻia ʻo De Novo, ke hoʻokumu nei ka FDA i nā koina i kapa ʻia nā mana kūikawā e wehewehe i nā koi e pili ana i ka lepili a me ka hoʻāʻo hana. Ke hoʻokō ʻia, hāʻawi nā mana kūikawā, i hui pū ʻia me nā mana maʻamau, i kahi hōʻoia kūpono o ka palekana a me ka pono no nā mea hana o kēia ʻano. Hoʻokumu pū kēia hana i kahi hoʻonohonoho hoʻoponopono hou, ʻo ia hoʻi, hiki i nā mea hana ma hope o ke ʻano like me ka hoʻohana like i manaʻo ʻia e hele ma ke ala 510 (k) o ka FDA, kahi e hiki ai i nā mea hana ke loaʻa ka ʻae ʻana ma o ka hōʻike ʻana i ke kūlike nui me kahi mea predicate.
Ua hāʻawi ka FDA i ka mana kūʻai aku iā Global Protection Corp.
He aha e lawe ʻia mai kēia ʻatikala:
- The symptomatic STI or recent STI diagnoses observed in the study were self-reported and may be the result of subjects having intercourse without a condom or may have preceded use of the One Male Condom, as STIs were not measured at baseline.
- This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster.
- The condoms, which will be marketed as the One Male Condom, are also indicated as a contraceptive to help reduce the risk of pregnancy and the transmission of STIs during vaginal intercourse.
