{"id":1491,"date":"2021-02-20T07:41:05","date_gmt":"2021-02-20T06:41:05","guid":{"rendered":"http:\/\/www.chirurgie-plasticka.cz\/cs\/?p=1491"},"modified":"2021-02-20T07:47:26","modified_gmt":"2021-02-20T06:47:26","slug":"docasne-pozastaveni-certifikatu-b-lite","status":"publish","type":"post","link":"https:\/\/chirurgie-plasticka.cz\/en\/archiv\/1491","title":{"rendered":"Do\u010dasn\u00e9 pozastaven\u00ed certifik\u00e1tu B-Lite\u00ae"},"content":{"rendered":"<p class=\"p1\"><span class=\"s1\"><b>V\u00e1\u017een\u00fd z\u00e1kazn\u00edku, \u00a0 \u00a0\u00a0<\/b><\/span><\/p>\n<p class=\"p1\">Jako p\u0159edn\u00ed v\u00fdrobce prsn\u00edch implant\u00e1t\u016f sv\u011btov\u00e9 \u00farovn\u011b bere POLYTECH Group jak\u00e9koli ot\u00e1zky t\u00fdkaj\u00edc\u00ed se na\u0161ich v\u00fdrobk\u016f velmi v\u00e1\u017en\u011b. Zav\u00e1zali jsme se zaji\u0161\u0165ovat, aby na\u0161e v\u00fdrobky spl\u0148ovaly nejen na\u0161e vlastn\u00ed vysok\u00e9 standardy kvality a bezpe\u010dnosti, ale tak\u00e9 v\u0161echny po\u017eadovan\u00e9 pr\u016fmyslov\u00e9 normy.<br \/>\n<span class=\"s1\">Ned\u00e1vno <\/span><span style=\"text-decoration: underline;\"><span class=\"s2\">do\u0161lo k identifikov\u00e1n\u00ed p\u0159\u00edtomnosti materi\u00e1lu n\u00e1pln\u011b B-Lite<\/span><span class=\"s3\"><sup>\u00ae<\/sup><\/span><span class=\"s2\"> na povrchu implant\u00e1t\u016f B-Lite<\/span><span class=\"s3\"><sup>\u00ae<\/sup><\/span><\/span><span class=\"s1\">. Integrita obal\u016f na\u0161ich implant\u00e1t\u016f nebyla v \u017e\u00e1dn\u00e9m p\u0159\u00edpad\u011b zpochybn\u011bna. Na\u0161e anal\u00fdza zjistila, \u017ee kapi\u010dka plnic\u00edho materi\u00e1lu obsahuj\u00edc\u00edho gel a mikrosf\u00e9ry se b\u011bhem v\u00fdroby dotkla vn\u011bj\u0161\u00edho povrchu obalu. \u00a0Tato zji\u0161t\u011bn\u00ed nep\u0159edstavuj\u00ed riziko pro bezpe\u010dnost pacientek. Zat\u00edmco spolu s ozn\u00e1men\u00fdm subjektem, spole\u010dnost\u00ed Medical Devices Certification GmbH (MDC), pracujeme na \u0159e\u0161en\u00ed tohoto probl\u00e9mu, jsme jako zodpov\u011bdn\u00fd v\u00fdrobce dobrovoln\u011b pozastavili z\u00e1silky s implant\u00e1ty B-Lite<\/span><span class=\"s4\"><sup>\u00ae<\/sup><\/span><span class=\"s1\">. \u00a0<br \/>\n<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">MDC n\u00e1s informovalo, \u017ee <\/span><span style=\"text-decoration: underline;\"><span class=\"s2\">jeden z na\u0161ich certifik\u00e1t\u016f pro implant\u00e1ty B-Lite<\/span><span class=\"s3\"><sup>\u00ae<\/sup><\/span><\/span><span class=\"s2\"><span style=\"text-decoration: underline;\"> byl do\u010dasn\u011b pozastaven<\/span>.<\/span><span class=\"s1\"> Jedn\u00e1 se o standardn\u00ed postup. \u00a0<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\"> \u00a0<\/span><span class=\"s1\">SUSPENSION OF MEDICAL DEVICE EU<\/span><\/p>\n<ul>\n<li><span class=\"s1\">Suspension is a temporary measure. During a suspension is given time to implement improvement measures which are intented to ensure that the medical device or IVD complies with the legislation. Once the medical device or IVD is again compliant, the notified body can terminate the suspension\u00a0\u00a0<\/span><\/li>\n<li><span class=\"s1\">Suspension of CE certificate only has an effect on those products which the manufacturer has not yet sold. Products which are already with a supplier (distributor) or health care institution can, however, still be used. After all, when these products were sold by the manufacturer, the CE certificate was still valid.<\/span><\/li>\n<\/ul>\n<p class=\"p1\"><span class=\"s1\">Vezm\u011bte pros\u00edm na v\u011bdom\u00ed, \u017ee <\/span><span style=\"text-decoration: underline;\"><span class=\"s2\">standardn\u00edch implant\u00e1t\u016f POLYTECH se situace nedot\u00fdk\u00e1<\/span><\/span><span class=\"s1\">, a i nad\u00e1le jsou V\u00e1m a Va\u0161im pacientk\u00e1m k dispozici.\u00a0\u00a0<br \/>\n<\/span><span class=\"s1\">Zdrav\u00ed a bezpe\u010dnost pacientek jsou pro POLYTECH Group prvo\u0159ad\u00e9 a i nad\u00e1le jsme si jisti bezpe\u010dnost\u00ed na\u0161ich v\u00fdrobk\u016f. V\u00e1\u017e\u00edme si d\u016fv\u011bry, kterou v n\u00e1s na\u0161i z\u00e1kazn\u00edci vkl\u00e1daj\u00ed, a chceme V\u00e1s ujistit, \u017ee pro vy\u0159e\u0161en\u00ed sou\u010dasn\u00e9 situace d\u011bl\u00e1me v\u0161e, co je v na\u0161ich sil\u00e1ch. \u00a0<br \/>\n<\/span><span class=\"s2\"><span style=\"text-decoration: underline;\">Mikrosf\u00e9ry se pou\u017e\u00edvaj\u00ed v cel\u00e9m t\u011ble p\u0159i mnoha l\u00e9ka\u0159sk\u00fdch postupech, v\u010detn\u011b p\u0159\u00edm\u00e9 injekc\u00ed do tk\u00e1n\u00ed a krevn\u00edho ob\u011bhu<\/span>.<\/span><span class=\"s1\"> Nep\u0159edstavuj\u00ed bezpe\u010dnostn\u00ed riziko. Krom\u011b toho jsou mikrosf\u00e9ry identifikovan\u00e9 na povrchu implant\u00e1t\u016f B-Lite \u00ae pokryty vrstvou vytvrzovan\u00e9ho silikonu, kter\u00fd d\u00e1le posiluje jejich p\u0159ilnavost k\u00a0povrchu implant\u00e1t\u016f.\u00a0<\/span><span class=\"s1\">\u00a0<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Na\u0161e prsn\u00ed implant\u00e1ty B-Lite<\/span><span class=\"s4\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> pro\u0161ly p\u0159ed uveden\u00edm na trh nejp\u0159\u00edsn\u011bj\u0161\u00edm v\u00fdzkumem, v\u00fdvojem a testov\u00e1n\u00edm trvaj\u00edc\u00edm v\u00edce ne\u017e 10 let. Od t\u00e9 doby na\u0161e implant\u00e1ty B-Lite<\/span><span class=\"s4\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> usp\u011bly ve v\u0161ech po\u017eadovan\u00fdch pr\u016fmyslov\u00fdch zkou\u0161k\u00e1ch p\u0159ed i po uveden\u00ed na trh. Za posledn\u00edch 7 let chirurgov\u00e9 ve v\u00edce ne\u017e 50 zem\u00edch sv\u011bta pou\u017eili des\u00edtky tis\u00edc implant\u00e1t\u016f. Ve skute\u010dnosti na\u0161e dosavadn\u00ed klinick\u00e9 zku\u0161enosti ukazuj\u00ed, \u017ee implant\u00e1ty B-Lite<\/span><span class=\"s4\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> maj\u00ed vynikaj\u00edc\u00ed bezpe\u010dnostn\u00ed profil, lep\u0161\u00ed ne\u017e jin\u00e9 st\u00e1vaj\u00edc\u00ed implant\u00e1ty.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Omlouv\u00e1me se za to, \u017ee v sou\u010dasnosti nem\u016f\u017eeme implant\u00e1ty B-Lite<\/span><span class=\"s4\"><sup>\u00ae <\/sup><\/span><span class=\"s1\">dod\u00e1vat, a za nep\u0159\u00edjemnosti, kter\u00e9 by to mohlo zp\u016fsobit. M\u016f\u017eeme V\u00e1s ujistit, \u017ee \u00fazce spolupracujeme s MDC, abychom zajistili rychl\u00e9 vy\u0159e\u0161en\u00ed situace.\u00a0<\/span><\/p>\n<p class=\"p1\"><span style=\"text-decoration: underline;\"><span class=\"s2\">Do\u010dasn\u00e9 pozastaven\u00ed je platn\u00e9 na dobu t\u0159\u00ed (3) m\u011bs\u00edc\u016f<\/span><\/span><span class=\"s1\">, berte tedy pros\u00edm v \u00favahu, \u017ee b\u011bhem t\u00e9to doby nemus\u00edme b\u00fdt schopni V\u00e1m implant\u00e1ty B-Lite<\/span><span class=\"s4\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> dodat. Pokud dojde ke zm\u011bn\u011b, budeme V\u00e1s okam\u017eit\u011b informovat. Mezit\u00edm m\u016f\u017eete jako alternativu zv\u00e1\u017eit implant\u00e1ty POLYTECH, jestli\u017ee se domn\u00edv\u00e1te, \u017ee by \u0161lo o vhodn\u00e9 \u0159e\u0161en\u00ed pro Va\u0161e pacientky.<br \/>\n<\/span><span class=\"s1\">Va\u0161i d\u016fv\u011bru v B-Lite<\/span><span class=\"s4\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> a POLYTECH v \u017e\u00e1dn\u00e9m p\u0159\u00edpad\u011b nebereme jako samoz\u0159ejmost. Pokud se rozhodnete pro alternativu <\/span><span class=\"s1\">v podob\u011b implant\u00e1t\u016f POLYTECH, budeme s V\u00e1mi spolupracovat na nalezen\u00ed nejlep\u0161\u00edho \u0159e\u0161en\u00ed pro V\u00e1s i Va\u0161e pacientky.<br \/>\n<\/span><span class=\"s1\">Jsme p\u0159esv\u011bd\u010deni, \u017ee v bl\u00edzk\u00e9 budoucnosti budeme schopni obnovit dod\u00e1vky a znovu V\u00e1m a Va\u0161im pacientk\u00e1m p\u0159in\u00e1\u0161et jedine\u010dn\u00e9 v\u00fdhody B-Lite<\/span><span class=\"s4\"><sup>\u00ae<\/sup><\/span><span class=\"s1\">, prvn\u00edch a jedin\u00fdch odleh\u010den\u00fdch prsn\u00edch implant\u00e1t\u016f. O\u00a0situaci V\u00e1s samoz\u0159ejm\u011b budeme nad\u00e1le pr\u016fb\u011b\u017en\u011b informovat a rovn\u011b\u017e n\u00e1s nev\u00e1hejte kontaktovat, pokud budete m\u00edt ohledn\u011b t\u00e9to z\u00e1le\u017eitosti jak\u00e9koli dotazy.\u00a0<\/span><\/p>\n<p class=\"p6\"><span class=\"s1\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-1492\" src=\"http:\/\/www.chirurgie-plasticka.cz\/wp-content\/uploads\/2021\/02\/podpis-300x118.png\" alt=\"\" width=\"300\" height=\"118\" srcset=\"https:\/\/chirurgie-plasticka.cz\/wp-content\/uploads\/2021\/02\/podpis-300x118.png 300w, https:\/\/chirurgie-plasticka.cz\/wp-content\/uploads\/2021\/02\/podpis.png 554w\" sizes=\"auto, (max-width: 300px) 85vw, 300px\" \/><\/span><\/p>\n<p class=\"p6\"><span class=\"s1\">Miroslav Schlaichert<br \/>\n<\/span><span class=\"s1\">Sanimpo, s.r.o.<br \/>\n<\/span><span class=\"s1\">v\u00fdhradn\u00ed distributor POLYTECH Group v\u00a0\u010cR<br \/>\n<\/span><span class=\"s1\">mischl@sanimpo.cz<\/span><\/p>\n<p><span class=\"s1\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-1493\" src=\"http:\/\/www.chirurgie-plasticka.cz\/wp-content\/uploads\/2021\/02\/sanipologo-300x85.png\" alt=\"\" width=\"300\" height=\"85\" srcset=\"https:\/\/chirurgie-plasticka.cz\/wp-content\/uploads\/2021\/02\/sanipologo-300x85.png 300w, https:\/\/chirurgie-plasticka.cz\/wp-content\/uploads\/2021\/02\/sanipologo.png 386w\" sizes=\"auto, (max-width: 300px) 85vw, 300px\" \/><\/span><\/p>\n<p class=\"p7\"><span style=\"text-decoration: underline;\"><span class=\"s2\">V\u00fdklad pojm\u016f <\/span><\/span><\/p>\n<p class=\"p8\"><span class=\"s5\">SUSPENSION \u2013 POZASTAVEN\u00cd<\/span><\/p>\n<p class=\"p8\"><span class=\"s1\">Pozastaven\u00ed je do\u010dasn\u00e9 opat\u0159en\u00ed. B\u011bhem \u00fa\u010dinnosti pozastaven\u00ed je certifika\u010dn\u00edm \u00fa\u0159adem poskytnuta lh\u016fta k\u00a0dopln\u011bn\u00ed a implementaci hodnot, test\u016f a studi\u00ed, vedouc\u00ed k\u00a0zaji\u0161t\u011bn\u00ed legislativn\u00ed shody zdravotnick\u00e9ho prost\u0159edku s\u00a0normami EU.<\/span><\/p>\n<p class=\"p8\"><span class=\"s1\">Po spln\u011bn\u00ed t\u011bchto po\u017eadavk\u016f je zdravotnick\u00fd prost\u0159edek uzn\u00e1m shodn\u00fdm a \u00fa\u010dinnost pozastaven\u00ed ukon\u010dena.<\/span><\/p>\n<p class=\"p8\"><span class=\"s1\">Pozastaven\u00ed m\u00e1 vliv pouze na v\u00fdrobky, je\u017e v\u00fdrobce dosud neprodal a nevydal ze sv\u00fdch v\u00fdrobn\u00edch z\u00e1vod\u016f.<\/span><\/p>\n<p class=\"p8\"><span class=\"s1\">V\u00fdrobky, je\u017e jsou v\u00a0dispozici lok\u00e1ln\u00edho distributora \u010di v\u00a0dispozici l\u00e9ka\u0159sk\u00fdch za\u0159\u00edzen\u00ed t\u00edmto nejsou dot\u010deny a leg\u00e1ln\u011b jsou d\u00e1le ur\u010deny k\u00a0aplikaci.<\/span><\/p>\n<p class=\"p8\"><span class=\"s1\">Nad\u00e1le po\u017e\u00edvaj\u00ed plnohodnotnou \u00farove\u0148 CE certifik\u00e1tu.<\/span><\/p>\n<p><em><a href=\"http:\/\/www.chirurgie-plasticka.cz\/wp-content\/uploads\/2021\/02\/B-Lite-rozhodnuti\u0301-0221-cz.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Do\u010dasn\u00e9 pozastaven\u00ed certifik\u00e1tu B-Lite (CZ)<\/a> <\/em><br \/>\n<a href=\"http:\/\/www.chirurgie-plasticka.cz\/wp-content\/uploads\/2021\/02\/POLYTECH_customer-letter-16022021-2.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><em>Do\u010dasn\u00e9 pozastaven\u00ed certifik\u00e1tu B-Lite (EN)<\/em><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jako p\u0159edn\u00ed v\u00fdrobce prsn\u00edch implant\u00e1t\u016f sv\u011btov\u00e9 \u00farovn\u011b bere POLYTECH Group jak\u00e9koli ot\u00e1zky t\u00fdkaj\u00edc\u00ed se na\u0161ich v\u00fdrobk\u016f velmi v\u00e1\u017en\u011b.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-1491","post","type-post","status-publish","format-standard","hentry","category-novinky"],"_links":{"self":[{"href":"https:\/\/chirurgie-plasticka.cz\/en\/wp-json\/wp\/v2\/posts\/1491","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/chirurgie-plasticka.cz\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/chirurgie-plasticka.cz\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/chirurgie-plasticka.cz\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/chirurgie-plasticka.cz\/en\/wp-json\/wp\/v2\/comments?post=1491"}],"version-history":[{"count":7,"href":"https:\/\/chirurgie-plasticka.cz\/en\/wp-json\/wp\/v2\/posts\/1491\/revisions"}],"predecessor-version":[{"id":1502,"href":"https:\/\/chirurgie-plasticka.cz\/en\/wp-json\/wp\/v2\/posts\/1491\/revisions\/1502"}],"wp:attachment":[{"href":"https:\/\/chirurgie-plasticka.cz\/en\/wp-json\/wp\/v2\/media?parent=1491"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/chirurgie-plasticka.cz\/en\/wp-json\/wp\/v2\/categories?post=1491"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/chirurgie-plasticka.cz\/en\/wp-json\/wp\/v2\/tags?post=1491"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}