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Regulation of in vitro diagnostics (IVDs) for use in clinical diagnostic laboratories: towards the light or dark in clinical laboratory testing?
-
Emmanuel J. Favaloro
,
Mario Plebani
Veröffentlicht/Copyright:
30. August 2011
Abstract
A revised framework for the regulation of in vitro diagnostic devices (IVDs) came into force in Australia on July 1, 2010 that aims to ‘ensure that public and personal health are adequately protected’, but which instead may lead to adverse outcomes in clinical diagnosis and management. The regulatory process aims to regulate all IVDs, including those used by clinical diagnostic laboratories, which are already subject to scrutiny as part of the current laboratory accreditation process. The IVD regulatory process initiated in Australia is similar to that used in Canada, but different to that currently operating in the USA and Europe. However, it is feasible that other countries will in time adopt a similar regulatory framework, given that many countries are involved in the development process. In this opinion paper, the regulatory process for IVDs across several geographies are outlined, as are some benefits and weaknesses of the new regulatory process now applied to Australia, as potentially planned for other regions of the world.
Keywords: accreditation; external quality assurance; in vitro diagnostics; IVDs; professional status; regulation
Received: 2011-3-16
Accepted: 2011-7-1
Published Online: 2011-8-30
Published in Print: 2011-12-1
©2011 by Walter de Gruyter Berlin Boston
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Schlagwörter für diesen Artikel
accreditation;
external quality assurance;
in vitro diagnostics;
IVDs;
professional status;
regulation
Artikel in diesem Heft
- Editorial
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- Reviews
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