Desaťročnica portálu pravo-medicina.sk prináša nové výzvy
JUDr. Ivan Humeník, PhD.
| 21.12.2017Články
Nové pravidlá EÚ pre bezpečnejšie zdravotnícke pomôcky
| 13.3.2017 | komentárov: 243
Dňa 7. marca 2017 prijala Rada EÚ nové nariadenia za účelom zvýšenia bezpečnosti zdravotníckych pomôcok v prospech pacientov pri súčasnom zachovaní včasného prístupu k inovatívnym zdravotníckym riešeniam v oblasti zdravotnej starostlivosti.
Zdravotnícke pomôcky a diagnostické zdravotnícke pomôcky „in vitro“ pomáhajú pri diagnostikovaní a prevencii chorôb, ako aj pri ich zmierňovaní a samotnej liečbe. Zahŕňajú širokú škálu výrobkov, od náplastí až po protézy bedrových kĺbov a načúvacie prístroje, od tehotenských testov až po testy HIV.
Nové pravidlá držia krok s najnovším technickým vývojom. Ich rozsah pôsobnosti bol rozšírený tak, aby zahŕňal určité výrobky, ktoré nemajú špecificky medicínsky účel, napríklad farebné kontaktné šošovky. Pri príprave nových pravidiel boli zohľadnené aj skúsenosti s celokovovými protézami bedrových kĺbov a chybnými silikónovými prsníkovými implantátmi, najmä tým, že sa bude vyžadovať systematická kontrola životne dôležitých implantátov zdravotníckymi odborníkmi.
Rada EÚ prijala dve nové nariadenia, ktorým sa:
- poskytuje silnejší mandát nezávislým notifikovaným subjektom pri posudzovaní zdravotníckych pomôcok pred ich uvedením na trh, pričom sa má posilniť dohľad vnútroštátnych orgánov nad týmito subjektmi; nové pravidlá tiež zabezpečujú, aby tieto notifikované subjekty spĺňali rovnaké vysoké bezpečnostné normy v celej EÚ; týmito opatreniami sa tak zvýši bezpečnosť zdravotníckych pomôcok
- zlepšuje dostupnosť klinických údajov o prístrojov a jasne sa stanovuje zodpovednosť výrobcov za sledovanie kvality, výkonu a bezpečnosti pomôcok uvedených na trh; to umožní výrobcom urýchlene reagovať na problémy, a pomôže im to neustále zlepšovať ich pomôcky na základe aktuálnych údajov
- zlepšuje vysledovateľnosť zdravotníckych pomôcok v celom dodávateľskom reťazci až po koncového používateľa alebo pacienta prostredníctvom jedinečného identifikačného čísla; to umožní v prípade bezpečnostných problémov prijať urýchlené a účinné opatrenia
- zriaďuje centrálna databáza, prostredníctvom ktorej sa poskytnú pacientom, zdravotníckym pracovníkom a verejnosti komplexné informácie o výrobkoch dostupných v EÚ; to im umožní prijímať lepšie rozhodnutia
Ďalšie kroky
Európsky parlament by mal tieto nariadenia prijať v apríli, nasledovať by malo ich uverejnenie v úradnom vestníku EÚ. V prípade zdravotníckych pomôcok sa nové pravidlá začnú uplatňovať po troch rokoch od ich uverejnenia v ÚV EÚ a pokiaľ ide o diagnostické zdravotnícke pomôcky in vitro, po uplynutí piatich rokov od ich uverejnenia.
Zdroje:
http://www.consilium.europa.eu/en/press/press-releases/2017/03/07-safer-medical-devices/
http://www.freedigitalphotos.net
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