The FDA is in the beginning stages of developing a program that would create a national surveillance net for orthopedic device implants.
Through such a national registry, the FDA would explore independent public and private registries that could feed claim information into a central agency-regulated network.
Orthopedic device manufacturers would benefit from the program because it would “offer more timely, comprehensive assessment of the ‘real world’ experience of their devices and an alternative means to conduct mandated postapproval studies,” an FDA spokesman said.
However, some in the industry caution that a government-run registry might hold too many limitations, given budget and resource restrictions. “One of the challenges the FDA and other agencies face is being able to devote resources in a continuing way. And our view is that registries will bring up more questions than answers,” David Lewallen, chairman of the American Academy of Orthopaedic Surgeons’ (AAOS) American Joint Replacement Registry Oversight Board and head of the American Association of Hip and Knee Surgeons, said. “It wouldn’t be impossible to do it through a government-run agency, but it is a bigger challenge.”
Another limitation is maintaining patient confidentiality. “Unless there are some safeguards in place, people would be wary of a federal-run system. It may even discourage some people from reporting adverse events,” Lewallen said.
The FDA has issued a request for quotations to receive input from the most useful data sources that choose to be involved. Quotations should be submitted by the first of September.