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