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Wyroby medyczne – w ich identyfikacji pomoże tzw. UDI, czyli Unikalna Identyfikacja Wyrobów Medycznych. Chodzi o zastosowanie takich oznaczeń, by przy użyciu niewielu znaków, zakodować jak najwięcej informacji – tak, by szybko i precyzyjnie rozpoznać z jakim produktem mamy do czynienia.

Przepisy dotyczące UDI zostały opracowane przede wszystkim przez Amerykańską Agencję do spraw Żywności i Leków oraz Komisję Europejską i inne organy regulacyjne na świecie. Kod UDI stopniowo będzie się pojawiał na coraz większej ilości urządzeń medycznych, etykiet i opakowań. Kod ten musi być czytelny dla człowieka (jako tekst jawny) oraz dla maszyny (opartej na technice automatycznej identyfikacji i odczytu danych – AIDC).

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Numeryczne lub alfanumeryczne oznaczenia, zamieszczone na wyrobach medycznych, pozwalają na jednoznaczną identyfikację konkretnego produktu na rynku. Są one generowane przy wykorzystaniu globalnie akceptowalnego i znanego standardu w zakresie identyfikacji i kodowania. Dzięki temu, że oznaczenie jest przedstawione jako jeden bądź dwa ciągi znaków, sama identyfikacja może być nie tylko precyzyjna, ale i błyskawiczna.

Kolejna zaleta UDI to wpływ na poprawę bezpieczeństwa pacjentów. I to zarówno z perspektywy producentów, szpitali i organów zajmujących się regulacjami dotyczącymi wyrobów medycznych.

UDI może oddziaływać także na usprawnienie procesów biznesowych w obszarze szeroko rozumianej ochrony zdrowia. Dla producentów to optymalizacja kosztów. Ponadto stoją za tym także jakość danych oraz wydajność całego procesu identyfikacji. Regulatorzy mogą zaś skuteczniej monitorować rynek i sprawnie reagować na przykład gdy zachodzi konieczność szybkiego wycofania jakiegoś produktu z łańcucha dostaw (także w przypadku obrotu międzynarodowego).

Uzgodniony i ujednolicony system identyfikacji – w skali świata – ma się przyczynić do ograniczenia wybranych błędów medycznych oraz do wyeliminowania różnic, będących skutkiem uwarunkowań prawnych w poszczególnych krajach. UDI ma tworzyć fundamenty takiego rozwiązania, które przyniesie korzyści różnym podmiotom – głównie: producentom, pacjentom oraz urzędom.

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Unikalna Identyfikacja Wyrobów Medycznych może mieć szerokie zastosowanie. Oznaczenia można wykorzystać do optymalizacji pracy magazynu. Ponadto mogą się sprawdzić w szpitalach, w punktach opieki zdrowotnej, a także w pracy organów regulujących oraz samych producentów.

Oprócz tego, mogą z nich korzystać detaliści – inne kody sprawdzą się przy znakowaniu detalicznych opakowań, inne przy kodowaniu dodatkowych informacji o produkcie, a jeszcze inne w przypadku transportu i magazynowania wyrobów.

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Znakowanie wyrobów medycznych, czyli wszystko co musisz wiedzieć o UDI

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Błąd: Brak formularza kontaktowego.

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Błąd: Brak formularza kontaktowego.

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Wysyłając formularz wyrażasz zgodę na przetwarzanie swoich danych osobowych

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Materiał opracowany przy współpracy z GS1 – oficjalną agencją akredytowaną przez FDA oraz przez KE, odpowiedzialną za nadawanie identyfikatorów UDI jak i wdrożenie standardów UDI na terenie naszego kraju.

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