{"id":7210,"date":"2017-12-13T00:00:00","date_gmt":"2017-12-13T00:00:00","guid":{"rendered":"https:\/\/lynx.legal\/news\/zdravotnicke-pomocky-na-jedno-pouzitie\/"},"modified":"2017-12-13T00:00:00","modified_gmt":"2017-12-13T00:00:00","slug":"zdravotnicke-pomocky-na-jedno-pouzitie","status":"publish","type":"post","link":"https:\/\/lynx.legal\/sk\/zdravotnicke-pomocky-na-jedno-pouzitie\/","title":{"rendered":"Zdravotn\u00edcke pom\u00f4cky na jedno pou\u017eitie"},"content":{"rendered":"\n<p>\u010cak\u00e1 Eur\u00f3psku \u00faniu kontrolovan\u00fd reprocessing jednorazov\u00fdch zdravotn\u00edckych pom\u00f4cok?  <\/p>\n<div style=\"text-align: justify;\">Zdravotn\u00edcka pom\u00f4cka na jedno pou\u017eitie je pom\u00f4cka ur\u010den\u00e1 na jedno pou\u017eitie pre jedn\u00e9ho pacienta po\u010das jednej proced\u00fary. Pom\u00f4cka na jedno pou\u017eitie by sa nemala pou\u017ei\u0165 opakovane, a to ani na rovnakom pacientovi, a rovnako by sa nemala ani renovova\u0165. Reprocessing (renovovanie) zah\u0155\u0148a dezinfekciu, \u010distenie, steriliz\u00e1ciu a balenie pou\u017eitej pom\u00f4cky, aby ju bolo mo\u017en\u00e9 op\u00e4tovne pou\u017ei\u0165. Pom\u00f4cky na jedno pou\u017eitie boli vyvinut\u00e9 za \u00fa\u010delom minimaliz\u00e1cie rizika infekcie a kr\u00ed\u017eovej kontamin\u00e1cie. V s\u00fa\u010dasnosti s\u00fa to \u010dasto technologicky vyspel\u00e9 pom\u00f4cky, ktor\u00e9 umo\u017e\u0148uj\u00fa vykon\u00e1va\u0165 proced\u00fary, ktor\u00e9 by sa inak vykona\u0165 nedali. Tieto jedine\u010dn\u00e9 n\u00e1stroje s\u00fa v\u0161ak \u010dasto renovovan\u00e9 a op\u00e4tovne vyu\u017e\u00edvan\u00e9 bez dostato\u010dnej kontroly, \u010d\u00edm ohrozuj\u00fa \u017eivoty pacientov. Regulovan\u00e9 a bezpe\u010dn\u00e9 renovovanie pom\u00f4cok na jedno pou\u017eitie by v\u0161ak mohlo pom\u00f4c\u0165 zn\u00ed\u017ei\u0165 n\u00e1klady na poskytovanie zdravotnej starostlivosti, chr\u00e1ni\u0165 \u017eivotn\u00e9 prostredie a zv\u00fd\u0161i\u0165 bezpe\u010dnos\u0165 pacienta. To si ale vy\u017eaduje jasn\u00fa, striktn\u00fa a jednotn\u00fa pr\u00e1vnu \u00fapravu.<\/div>\n<p>V s\u00fa\u010dasnosti neexistuje celoeur\u00f3pska legislat\u00edva na kontrolu renovovania pom\u00f4cok na jedno pou\u017eitie. Ka\u017ed\u00e1 \u010dlensk\u00e1 krajina m\u00e1 svoju vlastn\u00fa pr\u00e1vnu \u00fapravu. V Ma\u010farsku, \u010ceskej republike a pobaltsk\u00fdch krajin\u00e1ch je reprocessing pom\u00f4cok na jedno pou\u017eitie zak\u00e1zan\u00fd. Naopak v Nemecku je to do ur\u010ditej miery povolen\u00e9. Ostatn\u00e9 \u010dlensk\u00e9 krajiny nemaj\u00fa v tejto oblasti konkr\u00e9tnu legislat\u00edvu (napr. Slovensko, Po\u013esko). Tieto rozdiely zv\u00fdraz\u0148uj\u00fa potrebu jednotnej \u00fapravy na zabezpe\u010denie \u010do najvy\u0161\u0161ej bezpe\u010dnosti pacientov a ob\u010danov v Eur\u00f3pe, ako aj potrebu minimalizovania riz\u00edk pre v\u00fdrobcov t\u00fdchto pom\u00f4cok.<\/p>\n<div style=\"text-align: justify;\">Sp\u013a\u0148a v\u0161ak nov\u00e9 eur\u00f3pske nariadenie o zdravotn\u00edckych pom\u00f4ckach tieto potreby?<\/div>\n<div style=\"text-align: justify;\">Predov\u0161etk\u00fdm plat\u00ed, \u017ee renovovanie zdravotn\u00edckych pom\u00f4cok bude mo\u017en\u00e9 len v pr\u00edpade, ak sa \u010dlensk\u00e9 krajiny rozhodn\u00fa povoli\u0165 ho lok\u00e1lnou legislat\u00edvou. \u010clensk\u00e9 \u0161t\u00e1ty teda bud\u00fa ma\u0165 tzv. \u201eopt out \u201e mo\u017enos\u0165 a reprocessing neumo\u017eni\u0165. Ke\u010f\u017ee bud\u00fa plati\u0165 n\u00e1rodn\u00e9 \u00fapravy, m\u00f4\u017eu sa v jednotliv\u00fdch krajin\u00e1ch l\u00ed\u0161i\u0165. Napriek z\u00e1meru komisie teda pravidl\u00e1 renovovania nebud\u00fa z\u00e1v\u00e4zn\u00e9 pre v\u0161etky \u0161t\u00e1ty E\u00da. Z poh\u013eadu regul\u00e1cie je mo\u017en\u00e9, \u017ee krajiny, ktor\u00e9 renovovanie zak\u00e1\u017eu, bud\u00fa aj na\u010falej udr\u017eiava\u0165 status quo, ke\u010f\u017ee toto rie\u0161enie je pre ne pohodlnej\u0161ie. Nezabr\u00e1ni to v\u0161ak nekontrolovan\u00e9mu renovovaniu v zdravotn\u00edckych zariadeniach, ktor\u00e9 predstavuje podstatn\u00e9 rizik\u00e1 pre bezpe\u010dnos\u0165 pacientov.<\/div>\n<div style=\"text-align: justify;\">Za \u00fa\u010delom zabezpe\u010denia bezpe\u010dnosti pacientov bude pod\u013ea nov\u00e9ho nariadenia renov\u00e1tor pom\u00f4cky na jedno pou\u017eitie pova\u017eovan\u00fd za v\u00fdrobcu renovovanej pom\u00f4cky, a mal by preto plni\u0165 povinnosti v\u00fdrobcu. M\u00f4\u017ee teda potrebova\u0165 osved\u010denie notifikovanou osobou a jeho meno a adresa m\u00f4\u017eu by\u0165 uveden\u00e9 na renovovanej pom\u00f4cke. Tento postup m\u00e1 zabezpe\u010di\u0165, aby renovovan\u00e9 pom\u00f4cky mali rovnak\u00fa \u00farove\u0148 bezpe\u010dnosti ako p\u00f4vodn\u00e9 pom\u00f4cky na jedno pou\u017eitie.<\/div>\n<p>\u010clensk\u00e9 \u0161t\u00e1ty maj\u00fa mo\u017enos\u0165 vyu\u017ei\u0165 v\u00fdnimku pre zdravotn\u00edcke zariadenia (a pr\u00edpadne aj extern\u00fdch renov\u00e1torov). Tie potom nebud\u00fa podlieha\u0165 v\u0161eobecn\u00fdm pravidl\u00e1m, ktor\u00e9 platia pre v\u00fdrobcov, ak sa tak\u00e9to pom\u00f4cky na jedno pou\u017eitie bud\u00fa pou\u017e\u00edva\u0165 len v r\u00e1mci zdravotn\u00edckych zariaden\u00ed. T\u00e1to odch\u00fdlka od nariadenia bude povolen\u00e1 len v pr\u00edpade, ak zdravotn\u00edcke zariadenie sp\u013a\u0148a spolo\u010dn\u00e9 \u0161pecifik\u00e1cie alebo n\u00e1rodn\u00e9 predpisy a harmonizovan\u00e9 \u0161tandardy osved\u010den\u00e9 notifikovanou osobou. St\u00e1le v\u0161ak nie je jasn\u00e9, ako bud\u00fa spolo\u010dn\u00e9 \u0161pecifik\u00e1cie vyzera\u0165, a je tie\u017e ot\u00e1zne, \u010di notifikovan\u00e9 osoby bud\u00fa osved\u010dova\u0165 renova\u010dn\u00e9 smernice zdravotn\u00edckych zariaden\u00ed.<\/p>\n<div style=\"text-align: justify;\">Hoci je nariadenie o zdravotn\u00edckych pom\u00f4ckach krokom spr\u00e1vnym smerom, zd\u00e1 sa, \u017ee nie je schopn\u00e9 vytvori\u0165 harmonizovan\u00fd a jednotn\u00fd re\u017eim na zabezpe\u010denie bezpe\u010dn\u00e9ho renovovania pom\u00f4cok na jedno pou\u017eitie.<\/div>\n<p>Z\u00e1ver:<\/p>\n<div style=\"text-align: justify;\">Je nanajv\u00fd\u0161 ot\u00e1zne, \u010di nov\u00e9 nariadenie zv\u00fd\u0161i bezpe\u010dnos\u0165 pacientov. Zastavenie nekontrolovan\u00e9ho renovovania, ktor\u00e9 sa v s\u00fa\u010dasnosti deje v mnoh\u00fdch krajin\u00e1ch E\u00da, si vy\u017eaduje harmonizovan\u00fa a jednotn\u00fa pr\u00e1vnu \u00fapravu. Na jej dodr\u017eiavanie by mali dohliada\u0165 verejn\u00e9 org\u00e1ny a kontrolova\u0165 ju notifikovan\u00e9 osoby. Mo\u017enos\u0165 neprijatia nariadenia a \u0161peci\u00e1lne v\u00fdnimky pre nemocnice nerie\u0161ia rozpory v s\u00fa\u010dasn\u00fdch lok\u00e1lnych \u00faprav\u00e1ch. Naopak, z poh\u013eadu obchodn\u00fdch spolo\u010dnost\u00ed a z\u00e1konodarcov nech\u00e1va smernica mnoh\u00e9 ot\u00e1zky nezodpovedan\u00e9.<\/div>\n<p>Kontaktn\u00e1 osoba Bratislava:Mgr. Ing. D\u00e1vid Or\u0161ulaAdvok\u00e1tPartner<\/p>\n<p>T +421 2 57 88 00 88<a href=\"javascript:\/\/ EP_MESSAGE_PROTECTED\"><span><span><span><span><\/span><\/span><\/span><\/span><\/a><script type=\"text\/javascript\">emailProtector.addCloakedMailto(\"ep_436db71e\", 1);<\/script><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u010cak\u00e1 Eur\u00f3psku \u00faniu kontrolovan\u00fd reprocessing jednorazov\u00fdch zdravotn\u00edckych pom\u00f4cok? Zdravotn\u00edcka pom\u00f4cka na jedno pou\u017eitie je pom\u00f4cka ur\u010den\u00e1 na jedno pou\u017eitie pre jedn\u00e9ho pacienta po\u010das jednej proced\u00fary. Pom\u00f4cka na jedno pou\u017eitie by sa nemala pou\u017ei\u0165 opakovane, a to ani na rovnakom pacientovi, a rovnako by sa nemala ani renovova\u0165. Reprocessing (renovovanie) zah\u0155\u0148a dezinfekciu, \u010distenie, steriliz\u00e1ciu a balenie [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5471,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[103],"tags":[104],"class_list":["post-7210","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bnt","tag-slovakia"],"acf":[],"_links":{"self":[{"href":"https:\/\/lynx.legal\/sk\/wp-json\/wp\/v2\/posts\/7210","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lynx.legal\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lynx.legal\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lynx.legal\/sk\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lynx.legal\/sk\/wp-json\/wp\/v2\/comments?post=7210"}],"version-history":[{"count":0,"href":"https:\/\/lynx.legal\/sk\/wp-json\/wp\/v2\/posts\/7210\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lynx.legal\/sk\/wp-json\/wp\/v2\/media\/5471"}],"wp:attachment":[{"href":"https:\/\/lynx.legal\/sk\/wp-json\/wp\/v2\/media?parent=7210"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lynx.legal\/sk\/wp-json\/wp\/v2\/categories?post=7210"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lynx.legal\/sk\/wp-json\/wp\/v2\/tags?post=7210"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}