We like to think that medical equipment implanted in our bodies undergoes rigorous testing before it’s put inside a person. That’s not always the case, at least for cardiovascular devices. That’s according to an article in the Journal of the American Medical Association.
Researchers evaluated the FDA premarket approval process for 78 high-risk devices, such as pacemakers, stents and implanted defibrillators. They had assumed that these types of devices should and would be subject to random double-blinded studies with controls over an appropriate time-frame to investigate safety and efficacy.
But for 51 of the devices—65 percent—approval was based on a single study. Only 27 percent of studies were randomized, and only 14 percent were blinded. Only half of the devices were compared with controls.
The authors recognize the tension between sufficient testing and the need to get new drugs and devices to the public. But, they say, “The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can. In addition, although devices can be lifesaving, they also have great potential for risk and adverse events.”
[The above text is an exact transcript of this podcast.]