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Coraz więcej wyrobów medycznych będzie znakowanych w jednolity sposób. Dzięki temu, zarówno procesy biznesowe w obszarze ochrony zdrowia, jak i bezpieczeństwo pacjentów mają się wyraźnie poprawić.

W tym celu wykorzystywane będą nowe wzory kodu kreskowego UDI, czyli Unikalnej Identyfikacji Wyrobów Medycznych. Jej zadaniem jest klasyfikacja wyrobów medycznych pod takim kątem, by – analizując wyłącznie kod – można było szybko poczynić jednoznaczną identyfikację konkretnego wyrobu medycznego na rynku.

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UDI obejmuje wyłącznie wyroby medyczne. W jej zakres nie wchodzą produkty lecznicze! Sama zaś identyfikacja wspomnianych wyrobów odbywa się przy zastosowaniu standardów GS1. To organizacja działająca na całym świecie, w skład której wchodzi 114 organizacji krajowych, obsługujących łącznie 150 państw. Każdego dnia skanowanych jest jej 6 miliardów kodów.

Dzięki uporządkowaniu oznaczeń i jednoczesnemu ujednoliceniu tego systemu w wielu krajach, identyfikacja danego produktu może się odbywać bardzo sprawnie. Co więcej, choć na pierwszy rzut oka na danym opakowaniu może być zawartych niewiele informacji, to w rzeczywistości – kiedy „spojrzy” na nie właściwy adresat, znający standardy GS1, odczyta z niego wiele danych, zamieszczonych na małym obszarze.

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Kluczowym elementem umożliwiającym łączenie różnych modułów Europejskiej Bazy Danych o Wyrobach Medycznych jest podstawowy identyfikator wyrobu Basic UDI-DI. W celu jego wprowadzenia, organizacja GS1 stworzyła swój nowy identyfikator – to tzw. GMN (z ang. Global Model Number), czyli Globalny Numer Modelu. Jego zadaniem jest jednoznaczna i sprawna identyfikacja modelu wyrobu przez cały cykl jego funkcjonowania – od projektu, przez proces produkcji, zaopatrzenia, użytkowania i wreszcie konserwacji oraz usuwania.

Nowy identyfikator ma służyć głównie regulatorom. Fizycznie nie znajdzie się on na samym opakowaniu wyrobu (oznacza to, że nie będzie przedstawiony w żadnym nośniku danych – na przykład na kodzie kreskowym). W związku z tym, że różne wyroby mogą być wprowadzane na rynek na podstawie tej samej specyfikacji technicznej, to GMN ma pomóc w ich grupowaniu w ramach jednego modelu. Przy okazji warto pamiętać, że Basic UDI-DI (GMN) może mieć maksymalnie 25 znaków – w tym dwa obowiązkowe znaki kontrolne.

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W przypadku wyrobów medycznych można zastosować kilka oznaczeń, zgodnych z UDI. Po pierwsze kody kreskowe. Po drugie część statyczna, czyli indentyfikator urządzenia (GTIN), na który składają się cyfry oznaczające kolejno: krajowy prefiks (dla Polski: 590), prefiks firmy, oznaczenie produktu oraz cyfra kontrolna. Po trzecie można zastosować część dynamiczną, czyli identyfikator produkcji (składają się na niego na przykład: data ważności, data produkcji, numer partii oraz numer seryjny).

Krótko mówiąc, chodzi o zastosowanie dwóch typów oznaczeń – takich, które odczyta człowiek oraz takich, które rozszyfruje przystosowana do tego maszyna. Przy okazji warto pamiętać, że UDI-DI powinien być nadany każdemu poziomowi pakowania (poza jednostką logistyczną), a czasami powinien się pojawić bezpośrednio na wyrobie. Warto pamiętać, że każdy poziom pakowania wymaga nadania indywidualnego numeru GTIN/UDI-DI.

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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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