Medical Device Identification System Proposed by FDA

A new tracking system proposed by federal health regulators aims to quickly identify problems with medical devices once they are on the market, and help reduce the risk of injuries caused by defective and dangerous products. 

On July 3, the FDA announced that it was looking to have most medical devices carry what would be known as a unique device identifier (UDI).

This would apply to most medical devices distributed in the United States, and could result in a database of information on medical devices that will tell regulators when there is a problem with a product and will provide crucial information to doctors to help them better determine which devices are appropriate to use on which patients.

The UDI would consist of two parts: a unique code of either numbers or a combination of numbers and letters specific to a device model, and a production identifier that would include production information for that device. By using those identifiers, vital information on those devices could be accessed through a public UDI database.

Doctors will be able to find out if a medical device has properties that might be inappropriate for a patient, and the system will also allow the FDA to quickly detect if a device is failing regularly or linked to other health problems.

The UDI would include batch numbers, lot numbers and other information about the medical device. It would not include patient information.

The FDA claims that if the plan is enacted as is, it would allow more accurate reporting of adverse event reports and they could be reviewed and analyzed more easily. The agency also hopes that the program would reduce medical errors, create a consistent standard for medical device information in electronic medical records, help better manage medical device recalls, and create a better way of looking at the global distribution chain which would make it easier to identify counterfeit devices and prepare for medical emergencies.

The FDA is taking public comment on the proposed rule for the next four months before it would be promulgated, or put into place. The plan would be phased in, with high-risk devices targeted for implementation first. As proposed, the plan would not extend to medical devices sold over-the-counter.

Need for Better Detection of Dangerous Medical Devices

The FDA was spurred on in the creation of the system by some high-profile medical device recalls in recent years, which critics argue should have been detected earlier, reducing the number of patients who were harmed by products that had already failed or caused injury in other patients.

One example is the August 2010 DePuy ASR hip recall, which was issued after the manufacturer acknowledged that the metal-on-metal implant was failing in about 12-13% of patients within the first five years. By the time the recall was issued, more than 93,000 DePuy ASR hips had been sold worldwide.

At the time of the recall, there was no U.S. hip implant registry, and the FDA’s mechanism for reporting problems, the Adverse Event Reporting system, is voluntary and often unreliable.

In recent years, serious concerns have been raised about the FDA’s ability to protect consumers from dangerous medical devices, after a number of product defects have been identified years after they were approved with little or no pre-market testing, essentially making consumers unwilling test subjects for new medical devices.

The FDA’s fast-track approval process, known as 510(k) approval, allows some medical devices to be approved without rigorous testing before they are introduced if the manufacturer is able to show that the device is “substantially similar” to a product already on the market. The approval process has also been criticized because of the lack of follow-up on reports that surface involving problems with the devices.

According to a report released by Consumer Reports earlier this year, most medical devices implanted in patients in the United States are approved through this fast-track process.  The report highlighted how there is no system in place by which the public, or even the government, can quickly research a product for past problems, leaving patients fairly defenseless against new devices that have not been adequately tested.