What UDI Means to Medical Patients

From thermometers and blood sugar meters to high-tech pacemakers and hip implants, medical devices help assess and treat millions of patients in California and across the U.S., but they are not problem free. When problems develop with medical devices – such as those implanted in patients – identifying the issue and tracking the defective medical devices is both critical and difficult to do. Now, a proposed Food and Drug Administration process to track medical devices could help.

It’s called the Unique Device Identification process, or UDI, and it would require nearly all medical devices to be tagged with one or more identification numbers. The FDA believes UDIs could help the FDA to identify problems with medical devices more quickly, to issue recalls that better target the problem devices and improve patient safety.

The proposed system is the result of legislation passed by Congress in 2007 that directed the FDA to establish such a system. The FDA released the proposed rule this summer for comments. The proposed rule is now in review, and once a final rule is announced, the UDI system is expected to be phased in over a period of years.

According to the FDA, benefits of the system include:

• Allowing more accurate reporting, reviewing and analyzing of adverse event reports, which could allow problem devices to be identified and corrected more quickly.
• A potential reduction of medical errors because healthcare professionals will be able to identify devices that need attention more quickly
• Providing a standard way to document the use of medical devices in electronic health records and other systems
• Allowing manufacturers, medical providers and others to better manage recalls

One person on the medical device industry says the proposed rule has forced different parts of the industry to communicate in ways they never have before. One device might have several different manufacturers, and another company may assemble the items. Companies must ensure that these manufacturers and suppliers will be in compliance.

When the UDI process will go alive has not been announced. Once it has been phased in, each device will have its own code. That will make tracking devices and their effectiveness easier for medical professionals, and it will also have a benefit for individual consumers. The FDA plans to create a database that will allow members of the public to look up information about a device. The database will not contain information about who uses a device.