{"id":223,"date":"2020-06-03T14:16:54","date_gmt":"2020-06-03T12:16:54","guid":{"rendered":"https:\/\/lifelonghearing.com\/?p=223"},"modified":"2025-04-17T05:09:23","modified_gmt":"2025-04-17T05:09:23","slug":"hleda-se-dvojite-zabezpeceni","status":"publish","type":"post","link":"https:\/\/lifelonghearing.com\/cs\/hleda-se-dvojite-zabezpeceni\/","title":{"rendered":"Hled\u00e1 se: dvojit\u00e9 zabezpe\u010den\u00ed"},"content":{"rendered":"

Neust\u00e1l\u00fd z\u00e1vazek k bezpe\u010dnosti a spolehlivosti sluchov\u00fdch implant\u00e1t\u016f<\/h1><\/div>

Schopnost sly\u0161et ob\u011bma u\u0161ima je duplikac\u00ed se z\u00e1lohou. U\u017eivatel\u00e9 o\u010dek\u00e1vaj\u00ed, \u017ee jejich implant\u00e1t bude spolehliv\u00fd a bezpe\u010dn\u00fd \u2013 bilater\u00e1ln\u00ed u\u017eivatel\u00e9 to o\u010dek\u00e1vaj\u00ed dvakr\u00e1t tolik.<\/strong><\/p>\n<\/div>

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Diskuse ohledn\u011b bezpe\u010dnosti implant\u00e1t\u016f se opakuje ka\u017ed\u00fd rok. V Rakousku je implantov\u00e1no p\u0159ibli\u017en\u011b 500 000 r\u016fzn\u00fdch l\u00e9ka\u0159sk\u00fdch produkt\u016f, kter\u00e9 zlep\u0161uj\u00ed kvalitu \u017eivota pacient\u016f. L\u00e9ka\u0159sk\u00e9 implant\u00e1ty se zam\u011b\u0159uj\u00ed na bezpe\u010dnost pacient\u016f. Tyto implant\u00e1ty je t\u0159eba pravideln\u011b znovu certifikovat.<\/p>\n

V roce 2019 do\u0161lo ke skand\u00e1lu s americk\u00fdm v\u00fdrobcem Medtronic: Byli obvin\u011bni z nesrovnalost\u00ed a p\u0159edpokl\u00e1dalo se, \u017ee maj\u00ed nevy\u0159e\u0161en\u00e9 probl\u00e9my se sv\u00fdmi kardiostimul\u00e1tory a inzul\u00ednov\u00fdmi pumpami.<\/p>\n

Schvalovac\u00ed proces v Evrop\u011b a USA<\/h2>\n

Evropsk\u00e9 na\u0159\u00edzen\u00ed o zdravotnick\u00fdch prost\u0159edc\u00edch rozd\u011bluje zdravotnick\u00e9 v\u00fdrobky do \u010dty\u0159 skupin: skupina I zahrnuje obvazy, skupina IIb zahrnuje produkty jako infuzn\u00ed soupravy, tekutiny do kontaktn\u00edch \u010do\u010dek nebo kondomy. Sluchov\u00e9 implant\u00e1ty pat\u0159\u00ed do skupiny III. A\u0165 u\u017e je zm\u011bn\u011bna d\u00e9lka elektrody, p\u0159id\u00e1n nebo odstran\u011bn kontakt, pou\u017eit nov\u00fd materi\u00e1l nebo je jen p\u0159edstavena nov\u00e1 aktualizace softwaru, ka\u017ed\u00e1 mal\u00e1 zm\u011bna implant\u00e1tu vy\u017eaduje nov\u00fd certifik\u00e1t. Schvalovac\u00ed procesy mohou trvat m\u011bs\u00edce, jeliko\u017e bezpe\u010dnost u\u017eivatel\u016f je v\u017edy na prvn\u00edm m\u00edst\u011b.<\/p>\n

Schv\u00e1len\u00ed v Evrop\u011b jsou nez\u00e1visl\u00e1 na schv\u00e1len\u00edch v USA. Zaveden\u00ed nov\u00e9ho typu implant\u00e1tu \u010dasto vy\u017eaduje dal\u0161\u00ed komplexn\u00ed a d\u016fkladn\u00e9 studie. To m\u016f\u017ee zpozdit uveden\u00ed nov\u00fdch produkt\u016f na trh, ale je to jedin\u00fd zp\u016fsob, jak zajistit maxim\u00e1ln\u00ed bezpe\u010dnost pro budouc\u00ed u\u017eivatele.<\/p>\n

Transparence a spolehlivost<\/h2>\n

Rakousk\u00fd v\u00fdrobce MED-EL se zavazuje ke spln\u011bn\u00ed p\u0159\u00e1n\u00ed u\u017eivatel\u016f ohledn\u011b bezpe\u010dnosti a spolehlivosti implant\u00e1tu. Ka\u017ed\u00fd z jejich ru\u010dn\u011b vyroben\u00fdch implant\u00e1t\u016f je navr\u017een tak, aby poskytoval dlouhodobou bezpe\u010dnost a spolehlivost. Spole\u010dnost nav\u00edc ji\u017e mnoho let zve\u0159ej\u0148uje aktu\u00e1ln\u00ed \u00fadaje o spolehlivosti jak pro implant\u00e1ty, tak pro zvukov\u00e9 procesory. Jsou snadno p\u0159\u00edstupn\u00e1 pro v\u0161echny z\u00e1jemce na webov\u00fdch str\u00e1nk\u00e1ch v\u00fdrobce.<\/p>\n

\u00dadaje o spolehlivosti jsou pln\u00e9 technick\u00fdch informac\u00ed a m\u016f\u017ee b\u00fdt docela obt\u00ed\u017en\u00e9 je pochopit. N\u011bkte\u0159\u00ed v\u00fdrobci zve\u0159ej\u0148uj\u00ed pouze vybran\u00e1 data z mnoha statistik, aby se prezentovali v co nejlep\u0161\u00edm sv\u011btle. MED-EL do sv\u00e9 statistiky o spolehlivosti zahrnuje ka\u017ed\u00fd zji\u0161t\u011bn\u00fd probl\u00e9m. Pokud byl nap\u0159\u00edklad implant\u00e1t po\u0161kozen v r\u00e1mci dopravn\u00ed nehody nebo po prod\u011blan\u00e9 nemoci, jsou tyto do dat tak\u00e9 zahrnuty.<\/p>\n

Jen pro p\u0159\u00edpad\u2026<\/h2>\n

Pokud se navzdory v\u0161em bezpe\u010dnostn\u00edm opat\u0159en\u00edm vyskytnou probl\u00e9my, kter\u00e9 mohou vypl\u00fdvat z funkce samotn\u00e9ho implant\u00e1tu nebo mohou m\u00edt na implant\u00e1t vliv, nap\u0159. poruchy nebo zdravotn\u00ed probl\u00e9m, z\u00e1kon vy\u017eaduje ofici\u00e1ln\u00ed zpr\u00e1vu do n\u011bkolika hodin. Tyto zpr\u00e1vy jsou shroma\u017e\u010fov\u00e1ny v centr\u00e1ln\u00edch datab\u00e1z\u00edch v Evrop\u011b a USA a jsou ve\u0159ejn\u011b p\u0159\u00edstupn\u00e9. Ka\u017ed\u00e1 zem\u011b m\u00e1 sv\u016fj vlastn\u00ed n\u00e1rodn\u00ed org\u00e1n, kter\u00fd tyto \u00fadaje koordinuje. V\u0161ichni v\u00fdrobci maj\u00ed ur\u010dit\u00fd mal\u00fd po\u010det implant\u00e1t\u016f, kter\u00e9 selh\u00e1vaj\u00ed a je t\u0159eba je explantovat. V posledn\u00edch letech se jak australsk\u00fd v\u00fdrobce implant\u00e1t\u016f Cochlear, tak spole\u010dnost Advanced Bionics\/Sonova, jej\u00ed\u017e implant\u00e1ty se vyr\u00e1b\u011bj\u00ed v USA, pot\u00fdkaj\u00ed s n\u011bkolika st\u00ed\u017enostmi z d\u016fvodu selh\u00e1n\u00ed, posledn\u00ed z nich byla zaznamen\u00e1na po\u010d\u00e1tkem roku 2020. N\u011bkte\u0159\u00ed u\u017eivatel\u00e9 v\u00fdrobk\u016f od t\u011bchto spole\u010dnost\u00ed \u0159e\u0161ili probl\u00e9m aktivn\u011b a po\u017eadovali reimplantaci, i kdy\u017e jejich implant\u00e1t dosud fungoval.<\/p>\n

\u201eJi\u017e t\u00e9m\u011b\u0159 30 let hrd\u011b vyr\u00e1b\u00edme v\u0161echny kochle\u00e1rn\u00ed implant\u00e1ty MED-EL p\u0159\u00edmo zde v na\u0161em s\u00eddle v rakousk\u00e9m Innsbrucku,\u201c uv\u00e1d\u00ed MED-EL na sv\u00fdch webov\u00fdch str\u00e1nk\u00e1ch. Kontrola kvality potvrzuje kvalitu strategie rakousk\u00e9ho v\u00fdrobce. V roce 2006 uvedla spole\u010dnost MED-EL na trh sv\u016fj prvn\u00ed titanov\u00fd implant\u00e1t. Porovn\u00e1n\u00ed spolehlivosti kochle\u00e1rn\u00edch implant\u00e1t\u016f u v\u0161ech v\u00fdrobc\u016f b\u011bhem tohoto obdob\u00ed ukazuje vynikaj\u00edc\u00ed spolehlivost implant\u00e1t\u016f MED-EL.<\/p>\n

Pro v\u0161echno, co \u017eivot p\u0159in\u00e1\u0161\u00ed<\/h2>\n

U\u017eivatel\u00e9 cht\u011bj\u00ed, aby byl jejich implant\u00e1t spolehliv\u00fd nejen v b\u011b\u017en\u00e9m ka\u017edodenn\u00edm \u017eivot\u011b, ale p\u0159i v\u0161em, co \u017eivot p\u0159in\u00e1\u0161\u00ed, v\u010detn\u011b l\u00e9ka\u0159sk\u00fdch prohl\u00eddek a o\u0161et\u0159en\u00ed. To je d\u016fvod, pro\u010d v\u00fdrobci kochle\u00e1rn\u00edch implant\u00e1t\u016f vynakl\u00e1daj\u00ed ve\u0161ker\u00e9 \u00fasil\u00ed, aby byla jejich za\u0159\u00edzen\u00ed kompatibiln\u00ed s p\u0159\u00edstroji vyu\u017e\u00edvan\u00fdmi p\u0159i vy\u0161et\u0159en\u00ed magnetickou rezonanc\u00ed (MR skeny), kter\u00e9 se st\u00e1le \u010dast\u011bji st\u00e1vaj\u00ed standardem p\u00e9\u010de. I zde MED-EL prokazuje jasnou v\u00fdhodu: Implant\u00e1t SYNCHRONY spole\u010dnosti MED-EL je prvn\u00ed implant\u00e1t, kter\u00fd u\u017eivatel\u016fm umo\u017e\u0148uje bezrizikov\u00e9 MR vy\u0161et\u0159en\u00ed p\u0159i 3 Tesla bez nutnosti p\u0159edchoz\u00edho chirurgick\u00e9ho odstran\u011bn\u00ed vnit\u0159n\u00edho magnetu.<\/p>\n

Po tomto revolu\u010dn\u00edm roz\u0161\u00ed\u0159en\u00ed kompatibility s MR skeny se \u0159ada nep\u0159\u00edjemn\u00fdch vedlej\u0161\u00edch \u00fa\u010dink\u016f pro u\u017eivatele kochle\u00e1rn\u00edch implant\u00e1t\u016f podstupuj\u00edc\u00ed MR stala minulost\u00ed: \u017e\u00e1dn\u00fd chirurgick\u00fd z\u00e1krok p\u0159ed vy\u0161et\u0159en\u00edm, \u017e\u00e1dn\u00e1 bolest b\u011bhem MR a \u017e\u00e1dn\u00e9 p\u0159eru\u0161en\u00ed sluchu, dokud nemohl b\u00fdt magnet navracen zp\u011bt.<\/p>\n

Magnetick\u00e9 pole p\u0159\u00edstroje MR m\u016f\u017ee vytv\u00e1\u0159et sluchov\u00e9 vjemy i bez zapnut\u00e9ho zvukov\u00e9ho procesoru. Ty v\u0161ak nebudou bolestiv\u011b hlasit\u00e9. Krom\u011b toho nebude m\u00edt magnetick\u00e9 pole \u017e\u00e1dn\u00fd dal\u0161\u00ed negativn\u00ed dopad na implant\u00e1t. Korejsk\u00e1 studie zkoumala bezpe\u010dnost vy\u0161et\u0159en\u00ed MR pro u\u017eivatele kochle\u00e1rn\u00edho implant\u00e1tu: zat\u00edmco u\u017eivatel\u00e9 kochle\u00e1rn\u00edho implant\u00e1tu jin\u00fdch v\u00fdrobc\u016f mohou za\u017e\u00edvat nepohodl\u00ed, u\u017eivatel\u00e9 implant\u00e1t\u016f MED-EL mohou bez probl\u00e9m\u016f podstupovat vy\u0161et\u0159en\u00ed MR, ani\u017e by s m\u011bli \u010dehokoli ob\u00e1vat.[1]<\/a> P\u0159e\u010dt\u011bte si d\u016fle\u017eit\u00e9 informace o MR vy\u0161et\u0159en\u00edch s kochle\u00e1rn\u00edmi implant\u00e1ty na webov\u00fdch str\u00e1nk\u00e1ch MED-EL.<\/p>\n

Inovace jsou d\u016fle\u017eit\u00e9. Stejn\u011b tak \u010destnost.<\/h2>\n

\"Hearing<\/p>\n

Ned\u00e1vno musel velk\u00fd v\u00fdrobce kochle\u00e1rn\u00edch implant\u00e1t\u016f st\u00e1hnout sv\u00e9 tvrzen\u00ed o kompatibilit\u011b MR vy\u0161et\u0159en\u00ed pro syst\u00e9my kochle\u00e1rn\u00edch implant\u00e1t\u016f, kter\u00e9 ji\u017e byly implantov\u00e1ny. To p\u0159edstavuje dvoj\u00ed riziko: nen\u00ed jist\u00e9, zda se tyto informace skute\u010dn\u011b dostanou k u\u017eivateli, zda u\u017eivatel sd\u011bl\u00ed tuto odchylku zdravotnick\u00e9mu person\u00e1lu a jak siln\u011b kompatibilita s MR ovlivnila kandid\u00e1ta p\u0159i v\u00fdb\u011bru za\u0159\u00edzen\u00ed tohoto v\u00fdrobce.
\nRakousk\u00fd v\u00fdrobce MED-EL zvolil jin\u00fd p\u0159\u00edstup: A\u010dkoli v\u0161echny kochle\u00e1rn\u00ed implant\u00e1ty MED-EL byly od roku 1994 kompatibiln\u00ed s MR a\u017e pro 1,5 Tesla, p\u0159i\u010dem\u017e sou\u010dasn\u00e1 SYNCHRONY je kompatibiln\u00ed a\u017e pro 3 Tesla, bylo vy\u017eadov\u00e1no individu\u00e1ln\u00ed l\u00e9ka\u0159sk\u00e9 posouzen\u00ed p\u0159ed ka\u017ed\u00fdm vy\u0161et\u0159en\u00edm MR. Teprve po desetilet\u00edch bez komplikac\u00ed se spole\u010dnost MED-EL rozhodla povolit MR sn\u00edmkov\u00e1n\u00ed pro u\u017eivatele kochle\u00e1rn\u00edch implant\u00e1t\u016f MED-EL za p\u0159edpokladu, \u017ee zdravotnick\u00fd person\u00e1l dodr\u017e\u00ed v\u0161echna po\u017eadovan\u00e1 bezpe\u010dnostn\u00ed opat\u0159en\u00ed pro MR. Odpov\u00eddaj\u00edc\u00ed pokyny jsou k dispozici v p\u0159\u00edru\u010dk\u00e1ch, informa\u010dn\u00edch let\u00e1c\u00edch a na webov\u00fdch str\u00e1nk\u00e1ch.<\/p>\n

Kvalita na prvn\u00edm m\u00edst\u011b<\/h2>\n

N\u011bkter\u00e9 spole\u010dnosti jsou hrd\u00e9 na sv\u00e9 \u0161irok\u00e9 portfolio produkt\u016f, od pinzet a\u017e po kardiostimul\u00e1tory; nebo hrd\u00e9 na rostouc\u00ed zisky pro sv\u00e9 akcion\u00e1\u0159e. Spole\u010dnost MED-EL up\u0159ednost\u0148uje soust\u0159edit se na sluchov\u00e9 implant\u00e1ty pro r\u016fzn\u00e9 typy a stupn\u011b ztr\u00e1ty sluchu a investuje velk\u00e9 procento sv\u00e9ho obratu do v\u00fdzkumu a v\u00fdvoje, aby byla jejich za\u0159\u00edzen\u00ed je\u0161t\u011b bezpe\u010dn\u011bj\u0161\u00ed. \u201eSpolehlivost pro n\u00e1s nen\u00ed jen procento ze zpr\u00e1vy o v\u00fdnosu pro investory,\u201c uv\u00e1d\u00ed spole\u010dnost na sv\u00fdch webov\u00fdch str\u00e1nk\u00e1ch. Kdy\u017e si vyberete MED-EL, je n\u00e1m jasn\u00e9, \u017ee vkl\u00e1d\u00e1te svou d\u016fv\u011bru do na\u0161ich rukou, tak\u017ee tu budeme v\u017edy pro v\u00e1s.<\/p>\n

\n

JE DOBR\u00c9 V\u011aD\u011aT<\/strong><\/p>\n

Transparentn\u00ed p\u0159ehled spolehlivosti implant\u00e1t\u016f MED-EL:https:\/\/www.medel.com\/hearing-solutions\/cochlear-implants\/reliability<\/a><\/p>\n

Informace o MR vy\u0161et\u0159en\u00ed a dal\u0161\u00edch l\u00e9\u010debn\u00fdch postupech se sluchov\u00fdmi implant\u00e1ty:
\nonline p\u0159ehled na https:\/\/www.medel.com\/important-safety-information<\/a><\/p>\n

Informa\u010dn\u00ed let\u00e1ky jsou k dispozici ke sta\u017een\u00ed na webov\u00fdch str\u00e1nk\u00e1ch MED-EL.<\/p>\n

\n

[1]<\/a> Kim et al., Adverse Events and Discomfort During Magnetic Resonance Imaging in Cochlear Implant Recipients, JAMA Otolaryngol Head Neck Surg<\/em>. doi:10.1001\/jamaoto.2014.2926<\/p>\n<\/blockquote>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"

Schopnost sly\u0161et ob\u011bma u\u0161ima je duplikac\u00ed se z\u00e1lohou. U\u017eivatel\u00e9 o\u010dek\u00e1vaj\u00ed, \u017ee jejich implant\u00e1t bude spolehliv\u00fd a bezpe\u010dn\u00fd \u2013 bilater\u00e1ln\u00ed u\u017eivatel\u00e9 to o\u010dek\u00e1vaj\u00ed dvakr\u00e1t tolik.<\/p>\n","protected":false},"author":5,"featured_media":32072,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[470],"tags":[419,422,412],"class_list":["post-223","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-veda","tag-bilateral","tag-hearing-implant-reliability","tag-hearing-implants"],"yoast_head":"\nHled\u00e1 se: dvojit\u00e9 zabezpe\u010den\u00ed - Czech<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lifelonghearing.com\/cs\/hleda-se-dvojite-zabezpeceni\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hled\u00e1 se: dvojit\u00e9 zabezpe\u010den\u00ed - Czech\" \/>\n<meta property=\"og:description\" content=\"Schopnost sly\u0161et ob\u011bma u\u0161ima je duplikac\u00ed se z\u00e1lohou. 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