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Semin Thromb Hemost 2013; 39(03): 235-249
DOI: 10.1055/s-0033-1336833
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Regulation in Hemostasis and Thrombosis: Part I—In Vitro Diagnostics

Emmanuel J. Favaloro
1   Department of Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), Pathology West, Westmead Hospital, Westmead, New South Wales, Australia
,
Mario Plebani
2   Department of Laboratory Medicine, University-Hospital, Padova, Italy
,
Giuseppe Lippi
3   Department of Pathology and Laboratory Medicine, Clinical Chemistry and Hematology Laboratory, Academic Hospital of Parma, Italy
› Author Affiliations
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Publication History

Publication Date:
12 March 2013 (online)

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Abstract

The diagnostic or test-performance process, as associated to the evaluation or diagnosis of hemostasis and thrombosis and related disorders, is influenced or controlled by the activity of a large number of professional, expert, and government organizations. These may be involved in driving standardization or harmonization, providing professional or expert guidelines, or in regulation of therapeutic products and diagnostic products such as in vitro diagnostic devices or reagents (IVDs). Although all organizations involved in this activity would propose an intention to drive improvements in diagnostics and human health and although there are benefits to the overall process of standardization and regulation for tests of hemostasis and thrombosis, it should also be recognized there are several specific problems and limitations to this process. As highlighted in this report, which specifically relates to the regulation of IVDs, several case studies are used as examples to show that regulation, aimed to reduce risks associated with the implementation of diagnostic testing, may instead encourage the adverse outcome of locking out clinically useful, new, and improved technologies and locking in old and outdated technologies. This has a potential for significant adverse outcomes related to the clinical diagnosis and management of hemostasis and thrombosis-related disorders.

Keywords

standardization - regulation - harmonization - hemostasis testing - diagnostic practice - in vitro diagnostics - IVDs
 

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