More than 20 years ago, a consumer advocacy group, the FDA, and a medical device manufacturer began searching for patients implanted with an artifical heart valve that had a potentially deadly defect. The 80,000 or so patients were spread all over the world and were very hard to find. Hundreds of patients already had died from the defect, and hundreds more have died since. Finding the patients and providing them (and their doctors) with information, including information on the risks and benefits of valve replacement surgery, would reduce (though not eliminate) the risks of death and serious injury.
In part because of the heart valve tragedy, in 1990, Congress passed a law authorizing the FDA to improve device tracking, but that effort was not very effective. As a result, as this Politico article explains:
Millions of Americans are walking around with artificial joints, pacemakers, stents and other implants. But federal regulators know more about where a pallet of dog food went than a batch of hip replacements. Unlike prescription drugs or, for that matter, food at the grocery store, medical devices have no uniform labeling system — like a bar code — that would allow a central, computerized database to keep track of them.
In 2007, Congress told the FDA to implement a system of unique electronic identifiers. Read the Politico article to learn why FDA rules implementing the 2007 law have been "stuck in the federal regulatory maze" for nearly five years.