FDA Steps Up Medical Device Monitoring, Finally

The Food and Drug Administration (FDA) finally seems to be taking something other than a head-in-the-sand approach to monitoring medical devices after they are approved and in use by patients.

The U.S. does not monitor medical devices after they go through the FDA’s approval process. Since most medical devices are approved without any requirement for clinical trials on humans, there is not much assurance that they really are actually safe and effective until after they are in use.

That’s how we’ve ended up with so many devices- defibrillators, faulty hip implants, pelvic floor mesh – which have proven unsafe in some patients.

Since the U.S. is not watching such things, it did not notice, for example, that the DePuy hip implants were failing far short of their 15-year performance promises.

It took Australia, with its National Joint Replacement Registry, a post-approval monitoring program, to notice the higher than expected revision rates of metal-on-metal hips and remove the DePuy ASR from market promptly, no doubt saving many people from a lifetime of complications.

So the U.S. is following suit. The FDA has just announced a final rule for the Unique Device Identification System (UDI). This will allow a device to be tracked once it is approved to see how it fares in real-life conditions.

First, each device will have a number assigned by the device maker identifying the device’s version or model. It will also have a unique number such as the production lot or batch, the date it was manufactured and its expiration date. This will appear in the form of a barcode, also known as AIDC (Automatic Identification and Data Capture).

But the FDA had to do some compromising with industry. What good is all of this device information if it appears on the label and packaging only? What if the patient eventually becomes separated from the original packaging?

To solve that problem, the FDA had proposed putting some of this information on an implantable medical device. That proposal was shot down by industry as too expensive, however for some external devices that undergo repeated use, the data will be marked directly on the device in the form of a readable barcode.

And since this information is no good without a corresponding database, the FDA will create a Global Unique Device Identification Database (GUDID), which is searchable by the public. The device identification will be entered minus any specific patient information.

When there is a problematic device, companies, doctors and patients will know sooner allowing any recall to be faster and more effective, says the FDA’s medical device director, Jeff Shuren, MD.

High-risk medical devices such as heart valves, hip prostheses and pacemakers will be introduced to the system first. Manufacturers will have one year to phase in the UDI on the label and packaging. Moderate risk or Class II devices will have three years and Class I, the least dangerous, will either be exempt or have five years to enter the information.

The plan is for this UDI system to go global since many U.S.-made devices are exported. Manufacturers also hope it cuts down on counterfeit medical devices.

The FDA always mindful of the “least burdensome” standard for the $100 billion-a-year medical device industry has issued its final role with the help of manufacturers as well as the public, according to its news release.