FDA Eyes Tracking Numbers To Target Faulty Medical Devices

The FDA may be preparing to unveil plans for a new medical device tracking system, which would alert them when devices like defibrillators and hip implants are prone to failure. 

The Wall Street Journal reports that later this month the FDA will introduce plans for a new safety-monitoring program that will include giving each medical device a tracking number.

Theoretically, when medical devices fail, the tracking number would be reported back to the FDA, allowing the agency to tell which devices fail more than they should.

The move comes amid continuing concern over St. Jude Riata defibrillator leads and mounting pressure to improve the FDA oversight of the medical device industry. 

The St. Jude Riatta leads, which are used with implantable cardioverter-defibrillators (ICDs), have externalized conductors that could poke through the leads insulation, causing an electrical hazard for consumers who had the small wires implanted into their body. A St. Jude defibrillator lead recall was announced last year, but patients were left with few options, since it is extremely risky to attempt to remove the faulty leads.

Last month a report in the Heart Rhythm Journal determined that at least 22 deaths have been associated with the Riata ICDs, a number which St. Jude Medical denies but competitor Medtronic says its own analysis supports.

According to the Wall Street Journal, FDA officials looking at the problem with the Riata leads and determined that there was no trigger in hospital reporting methods that alerts the FDA when a problematic medical device keeps being reported.

A tracking number would supposedly allow the agency to better detect when there was a consistent problem with a medical device. That number would link the agency to billing and medical records, and could potentially identify specific lots and batches of devices that may have a problem.

A number of failures discovered with medical devices years after they were approved have raised serious concerns about the FDA’s ability to protect consumers. The FDA’s fast-track approval process, known as 510(k) approval, which allows some medical devices to be approved without rigorous pre-market testing by showing that they are “substantially similar” to a product already on the market, 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 last month, 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.