Harvard Researchers Take FDA Approval of Implantable Cardiac Devices

Based on new documents uncovered within the bowels of the Food and Drug Administration (FDA), researchers at Harvard University have joined voices with many FDA watchers to conclude the way most medical devices make it to market does nothing to assure patient safety.

This X-ray shows an Implantable Cardioverter Defibrillator implanted into the upper left chest and the right ventricle of the heart.

Specifically, the researchers were looking at how the St. Jude Medical heart defibrillator and the Medtronic Sprint Fidelis implantable cardiac devices made it to market. These at one time underwent premarket approval (PMA) as a Class III medical device (highest risk) during which the manufacturer must undergo clinical trials to assure patient safety and efficacy.

The bulk of medical devices are approved through the antiquated 510(k) process, a sort of wink and a nod to the manufacturer and a green light to getting a device on the market in 2 months.

So the PMA assures safety, right? Theoretically, yes, but something else happened over the years.

Harvard researchers, publishing in the Journal of the American Medical Association (JAMA), point out that since the original PMA of these two devices, a host of slightly similar devices was allowed to be marketed. The manufacturer simply files a “supplement” when it wants to make changes to a product that has been approved. Change is the operative word. Nothing reportedly stops a device from being modified over and over and there are no clinical trials necessary to assure patients the device is safe for use. In the end, the device many not even resemble the original device.

For example, between the years 1979 to 2012, the FDA allowed 77 implanted devices for the heart such as pacemakers and defibrillators to be approved as well as 6,000 supplemental applications.

The St. Jude defibrillator and its recalled wire was approved in 1996 but had been revised 78 times. The Sprint Fidelis faulty lead had been modified 91 times. In fact the last time an implantable defibrillator underwent an actual premarket approval (PMA) was in the year 2000.

Since then, the number of annual supplement applications has changed from 77 to 704 a year – a ten-fold increase.

Without assurances of safety guess what happens? The FDA announced a recall of electrical wires in St. Jude Medical heart defibrillator but unfortunately, not before they were implanted in thousands of patients. The reason for the recall, the wires were defective just like the Medtronic Sprint Fidelis cardiac device which led to a recall because of faulty wires in 2007.

The defective wiring can deliver painful shocks or fail when they are needed which led to several deaths. The surgery to replace the leads is complicated and dangerous so patients are put between a rock and a hard place.

The trade organization, AdvaMed, likes things just the way they are. Talking to the New York Times, a VP with the group says the FDA has “rigorous requirements for safety and effectiveness” and that the FDA could conduct even more thorough reviews if it thought it was necessary.

Let’s not forget that manufacturers already have immunity from lawsuits by consumers if a device receives FDA’s premarket approval.

So keeping score here- the device may bear no resemblance to the original device after it undergoes many supplemental revisions but consumers can’t take the maker to court when they are harmed by the unapproved device. And the manufacturers have established with the FDA the “least burdensome” standard to allow them to market a device quickly.

Who exactly does the FDA work for really?