Menu Zamknij

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Dla kogo jest UDI, czyli słów kilka o identyfikacji wyrobów medycznych

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Na etykietach i opakowaniach różnych wyrobów medycznych wkrótce pojawią się nowe oznaczenia. To efekt opracowania tzw. UDI, czyli Unique Device Identification. To system przeznaczony do właściwej identyfikacji urządzeń medycznych.

Za utworzeniem systemu UDI stoją Amerykańska Agencja ds. Żywności i Leków (FDA), Komisja Europejska, a także inne światowe organy regulacyjne. Celem tego rozwiązania jest przede wszystkim poprawa dwóch aspektów – po pierwsze: bezpieczeństwa pacjentów, a po drugie: procesów biznesowych w obszarze ochrony zdrowia.

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UDI – jak to ma działać ?

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Unikalna Identyfikacja Wyrobów Medycznych została stworzona do znakowania i identyfikacji urządzeń medycznych w globalnym łańcuchu dostaw opieki zdrowotnej. Jest adresowana do wszystkich tych, którzy zajmują się identyfikacją na każdym etapie „życia” danego modelu wyrobu. Dotyczy to zarówno jego projektowania, produkowania, zaopatrywania, użytkowania, konserwacji i usuwania.

Dokładniej mówiąc, w sposób jednoznaczny na to wszystko pozwala Globalny Numer Modelu, czyli GMN (Global Model Number). To nowy identyfikator, opracowany przez GS1 (organizację akredytowaną m.in. przez Amerykańską Agencję ds. Żywności i Leków oraz Komisję Europejską właśnie do celów UDI).

Głównym kluczem dostępu do bazy, a także tym służącym do wprowadzania informacji na temat konkretnych wyrobów medycznych, będzie BASIC UDI-DI. Zadaniem tego elementu jest łączenie różnych modułów Europejskiej Bazy Danych o Wyrobach Medycznych. Maksymalna długość Globalnego Numeru Modelu to 25 znaków – w tym dwa obowiązkowe znaki kontrolne.

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Komu ma służyć nowy identyfikator ?

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Po pełnym wdrożeniu UDI, większość urządzeń medycznych będzie mieć unikatowy identyfikator urządzenia. Zostanie on nadany w takiej formie, którą mogą odczytać zarówno ludzie, jak i maszyny. Takie oznakowanie znajdzie się na etykietach i opakowaniach, a tam, gdzie jest to wymagane – także na samych urządzeniach.

Nowy identyfikator będzie służył głównie regulatorom. Fizycznie nie znajdzie się on na żadnym nośniku danych (na przykład na kodzie kreskowym na opakowaniu wyrobu). Jednak w związku z tym, że różne wyroby mogą być wprowadzane na rynek na podstawie tej samej specyfikacji technicznej, Globalny Numer Modelu będzie wykorzystywany do ich grupowania w ramach jednego modelu.

Unikalny Identyfikator Wyrobów Medycznych posłuży przede wszystkim ich producentom, szpitalom, a także regulatorom (organom regulującym). Jego wdrożenie ma umożliwić jednoznaczną identyfikację urządzeń medycznych. Dane w tym przypadku uzyskane pozwolą na ograniczenie wybranych błędów medycznych, a także na skuteczniejsze monitorowanie działań niepożądanych oraz usprawnione wycofywanie wadliwych wyrobów medycznych z łańcucha dostaw.

UDI ma ułatwić pracę także w magazynach oraz w punktach opieki zdrowotnej. Unikalny Identyfikator Wyrobów Medycznych posłuży także detalistom, czyli osobom, które sprzedają towary jednorazowo – w niewielkich ilościach.

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Zobacz jak IBCS Poland może pomóc przy wdrożeniu standardów UDI w procesie etykietowania

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Znakowanie wyrobów medycznych, czyli  wszystko co musisz wiedzieć o UDI

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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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