FOR IMMEDIATE RELEASE:
July 7, 2000

Contacts: Linda Joy
(301) 975-4403

MA 2000-07

Calendar Announcement

NIST to Host Workshop on Measurement Traceability
for Clinical Lab Testing and In Vitro Diagnostic Systems 
 

The National Institute of Standards and Technology, an agency of the Commerce Department's Technology Administration, will host a workshop, Nov. 2-3, 2000, to address a potential non-tariff trade barrier for U.S. medical diagnostic devices in the European Union. The workshop, "Measurement Traceability for Clinical Laboratory Testing and In Vitro Diagnostic Test Systems," is geared for members of the medical diagnostics industry, professional organizations, government and national and international standards-developing organizations.

A new European Union directive on in vitro diagnostics will require that calibration of all new medical diagnostic devices be traceable to "standards of a higher order" by 2003. Existing diagnostic products, without the European Union stamp of approval, can remain on the market only until 2005. Although NIST produces many reference materials for medical tests, the United States currently does not have a formalized system for tracing the accuracy of all tests performed with in vitro diagnostic devices and systems. U.S. manufacturers, who produce over 60 percent of the devices sold in Europe, potentially could have their products challenged on the basis of this directive.

This two-day workshop will be held at NIST, Gaithersburg, Md. It is co-sponsored by NIST, the American Association for Clinical Chemistry, the Centers for Disease Control and Prevention, the Health Industry Manufacturers Association and the National Committee for Clinical Laboratory Standards. Organizers will involve all interested parties in a discussion of how to establish the needed measurement traceability and reference systems for health care manufacturers. Registration is $250 and due by Sept. 15.

Visit www.cstl.nist.gov/nist839/ivd.html on the World Wide Web for further details including invited speakers, breakout sessions and an online registration form.

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