The Institute for International Research: Action Taken by FDA to Mandate Bar Codes on Human Drug Products and Blood


NEW YORK, March 14, 2003 (PRIMEZONE) -- As manufacturers face intense pressure to help reduce the number of medical errors, today the Food and Drug Administration (FDA) entered into the DMB (The Document Management Branch of the FDA) a proposed rule to mandate bar codes on all human drug and blood products.

George Wright, a recognized leader in healthcare bar coding and speaker at IIR's Bar Coding Conference (Washington, DC, March 27-28) stated this morning, "This is a historic moment. Industry leaders have anticipated this for a decade. The effect on improved patient safety can not be overestimated." Industry now has 90 days to submit reactions to the proposed rule.

According to Ceci Connolly of the Washington Post, "The issue of medical errors grabbed headlines last month when 17-year-old transplant patient Jesica Santillan died after doctors at Duke University Medical Center gave her organs of the wrong blood type. But experts say more mundane errors take a huge toll medically and financially." Source: Washington Post (March 8, 2003/ Page A07)

In anticipation of the ruling, The Institute for International Research has scheduled a two-day industry driven conference addressing the bar coding issue. Mary C. Gross, Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, will speak on the status and direction of the FDA bar code initiative at IIR's Bar Code Implementation Strategies Conference taking place March 27-28, 2003 in Washington, DC.

Visit: www.iirusa.com/barcode

Julia Douthart, Event Director, said, "Knowing what is expected is only the beginning. In order to develop a comprehensive bar coding program, manufacturers face numerous technical challenges and a significant capital investment. This forum provides insight for those making and those who must meet bar code mandates."

Over 200 delegates are expected to attend and benefit from hearing two days of keynote presentations from representatives of The Food and Drug Administration (FDA), National Coordinating Council for Medication Error Reporting and Prevention, Uniform Code Council (UCC), St. Alexius Medical Center, Novation, Premier, Inc., Brigham and Women's Hospital, Cooper Group, LLC, Baxter Healthcare, Boehringer Ingelheim--Roxane Laboratories, Inc., Hoffman-La Roche, Pfizer, Product Identification & Processing Systems, Inc. (PIPS), Quint Company, Inc., Zebra Technologies, Abbott Laboratories, American Pharmaceutical Partners, Inc., Wyeth - Ayerst Pharmaceuticals, Pharmacia, Business Technology Group, and Karen Longe & Associates, Inc.

This event is open for registration. For more information, call (888) 670-8200 or visit www.iirusa.com/barcode.

FDA dockets entry can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0204-npr00001-vol1.pdf.

About IIR

The Institute for International Research (IIR) is the world's leading knowledge and skills transfer company with a global network of 44 companies and 109 operating units. IIR works with more than 600,000 business executives annually, providing them with the knowledge and skills through training, conferences, seminars, e-learning, blended solutions, publications, exhibitions, consulting and mentoring. Visit www.iir-global.com for more information.



            

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