FDA working on device registry
August 26th, 2008 joshua
In an age where information is a Google search away, the Food and Drug Administration is having a difficult time creating a national registry of implanted orthopedic joints.
Several other nations have such registries already begun, and the FDA has talked about starting such a registry, but when it comes time to actually compile it, it balks.
In a release, the FDA says it is in the beginning stages of creating a database of these controversial medical devices. Joints like artificial hips and knees have been linked to injuries and post-operative failures, often requiring additional corrective surgeries.
If the FDA demanded more disclosure from the companies making these questionable devices they’d already have this list compiled.
Once it’s complete, the FDA would like to have a comprehensive list of medical devices and any formal complaints logged against it and its manufacturer.
Also hampering the effort the FDA can put toward this registry is its budget restraints. It already has a difficult to impossible time inspecting the facilities making the devices, and there is a chance it doesn’t even know all that exist, as was the case with the Chinese facility charged with making the active ingredient in the blood thinner, heparin.
The FDA should create this registry, but to rely on anything but third-party information which is destined to be skewed or unreliable, will open this registry to constant criticisms rather than it serving as an important resource.
