FDA Approval

Link  http://www.govhealthit.com/online/news/350502-1.html

By Peter Buxbaum  Published on August 4, 2008

The Food and Drug Administration has proposed a program that would query public and private databases to help study the efficacy of orthopedic implants.

FDA will issue a request for quotations next month in an effort to identify companies that could evaluate orthopedic implant registries for participation in the program.

The program is part of the broader Sentinel Initiative FDA launched earlier this year. The broader effort is intended to monitor and provide early warnings of potential problems with FDA-approved medical products.

The implant program would “create a national network of registries for the FDA in support of the Sentinel Initiative,” according to an FDA announcement posted July 25. Implants of interest would include total hip, total knee, hip resurfacing, intervertebral disc implants and ankle devices.

The program would create a distributed network to enable FDA to query multiple data sources for information about medical products. As envisioned, queries to the network would be accomplished with minimal data transfer and would protect patient privacy.

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,” an FDA spokesperson said. “Most adverse events are never reported, and when they are, the information provided is incomplete.”

FDA officials envision being able to search government databases, such as the Medicare database, private and public medical claims databases, and electronic health record systems, the spokesperson said.

The proposed evaluations of the orthopedic implant registries will lead to recommendations for involvement of the most promising data sources, the FDA announcement states.

The Sentinel Initiative “could also ultimately facilitate data mining and other research-related activities,” the spokesperson added.