FDA Unveils New Medical Device Tracking System

From knee replacements to defibrillators and stents, all kinds of medical devices will be coded with a unique identifier and tracked electronically under a new system announced last week by the U.S. Food and Drug Administration.

The new FDA rules are intended to make it much easier for doctors and patients to understand which devices have been identified as problematic — even recalled — by manufacturers and federal health officials.

According to the FDA press release on the new “unique device identification” system, there are two key components:

    The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label. The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier.

Learn more about the FDA’s new Unique Device Identification System.

The past decade or so has seen an influx of new medical devices on the market, and an aging population is living longer and putting those devices to good use. A surge in medical device defects was almost inevitable.  Don’t take our word for it. Check out the FDA’s list of Recent Medical Device Recalls, and see how long it takes you to scroll all the way down.

Legal action over defective defibrillators, hip implants, and other medical devices has also made headlines in recent years, and cases like these raise some pretty unique legal issues. Learn more about Lawsuits Over Defective Medical Devices.