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FDA Proposes Program To Boost Orthopedic Device Safety

Program would search public and private databases

By: Michael Barbella

Managing Editor, Rodman Media

FDA wants to create a program that would search public and private databases to help determine the efficacy of orthopedic implants, Government Health IT reports.

The program is part of a larger effort, called the Sentinel Initiative, launched by FDA earlier this year to monitor and provide early warnings of potential problems associated with FDA-approved medical products.

The implant program would create a distributed network to let the department search multiple data sources for information about medical products. Officials hope to be able to search government databases, such as the Medicare database, private and public medical claims databases, and electronic health record systems, according to an FDA spokesperson.

FDA’s current post-market surveillance programs require “health care professionals and patients to first recognize an association between an adverse effect and a medical product, and then report it to FDA,” the spokesperson said.

Next month, FDA will issue a request for quotations to find companies that could evaluate orthopedic implant databases for inclusion in the program.

SOURCE: iHealthBeat

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