My March 28th blog titled “Study Links St. Jude Heart Wires to 22 Deaths” discussed a recent Heart Rhythm journal study that blamed a number of patient deaths on faulty lead wiring in previously-recalled St. Jude Medical heart defibrillators. Concern over medical device failure rates was soon echoed by top cardiologist Dr. Nissen, as detailed in my March 29th blog “Top Cardiologist: There is Consistent Failure of Medical Devices.”
Now, upon ever-increasing pressure from practitioners and patients alike, it appears that the U.S. Food and Drug Administration (“FDA”) is finally taking notice. Reports are surfacing that later this month the FDA will unveil a more rigorous program to monitor medical devices. Included in their proposal will be device tracking system, which will require hospitals to report a faulty device via its newly-assigned unique tracking number. As the FDA’s Deputy Director for Science conceded, “[w]e would concur that the current efforts are not constructed to identify underperforming products in the marketplace . . . . We need a robust data-collection methodology.” The device tracking system aspires to solve this problem.
The contemplated system, which is a strict departure from the conventional voluntary reporting system still employed today, will promote transparency and alert the FDA of device failure in a more timely fashion. In fact, in 2008 the FDA, through its voluntary reporting program, sought defibrillator performance input from numerous hospitals participating in the program. However, as the Deputy Director recalls, “there was not a specific signal” to alert the FDA of St. Jude Medical’s problems. Accordingly, hospitals, practitioners, patients and the FDA all remained largely unaware of the aggregate medical emergency taking shape.