Health Information System - Medical Devices Nomenclature System

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F17%3A50014270" target="_blank" >RIV/62690094:18450/17:50014270 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/61989100:27240/17:10244470

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Health Information System - Medical Devices Nomenclature System

Popis výsledku v původním jazyce

The subject of the article is to evaluate the current systems of internationally agreed generic descriptors for the identification of medical devices. The aim of this article is to assess the strengths and weaknesses of the Global Medical Device Nomenclature (GMDN), officially recognized within the European Economic Area (EEA), as compared to Unique Device Identity (UDI) valid in the United States. The methods used include a literature review of available professional sources, PEST analysis and guided structured interviews with experts from the Czech Association of Manufacturers of Medical Devices (CzechMed). Comparison of both systems was also performed. The introductory part of the article defines the basic concepts and obligations that international regulations set for MD manufacturers. It also describes the current situation in information systems associated with MDs. The comparison focuses on two transnational systems - Global Medical Devices Nomenclature (GMND) and Unique Device Identity (UDI). The synthesis of knowledge highlights the strengths and weaknesses of both systems. The conclusion of the article deals with the overall evaluation and recommendations on the given issue.

Název v anglickém jazyce

Health Information System - Medical Devices Nomenclature System

Popis výsledku anglicky

The subject of the article is to evaluate the current systems of internationally agreed generic descriptors for the identification of medical devices. The aim of this article is to assess the strengths and weaknesses of the Global Medical Device Nomenclature (GMDN), officially recognized within the European Economic Area (EEA), as compared to Unique Device Identity (UDI) valid in the United States. The methods used include a literature review of available professional sources, PEST analysis and guided structured interviews with experts from the Czech Association of Manufacturers of Medical Devices (CzechMed). Comparison of both systems was also performed. The introductory part of the article defines the basic concepts and obligations that international regulations set for MD manufacturers. It also describes the current situation in information systems associated with MDs. The comparison focuses on two transnational systems - Global Medical Devices Nomenclature (GMND) and Unique Device Identity (UDI). The synthesis of knowledge highlights the strengths and weaknesses of both systems. The conclusion of the article deals with the overall evaluation and recommendations on the given issue.

Druh

D - Stať ve sborníku

CEP obor

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OECD FORD obor

50204 - Business and management

Projekt

<a href="/cs/project/GA17-03037S" target="_blank" >GA17-03037S: Hodnocení investic do vývoje zdravotních prostředků</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název statě ve sborníku

CEFE 2017 – Central European Conference in Finance and Economic

ISBN

978-80-553-2906-2

ISSN

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e-ISSN

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Počet stran výsledku

10

Strana od-do

548-557

Název nakladatele

Technical University of Košice

Místo vydání

Košice

Místo konání akce

Košice

Datum konání akce

20. 5. 2017

Typ akce podle státní příslušnosti

EUR - Evropská akce

Kód UT WoS článku

000503056700057