According to a recent article on the effectiveness of post-market surveillance, medical device manufacturers “often fail to properly conduct safety studies” and the Food and Drug Administration (FDA) “provides scant oversight” in post-approval monitoring of these devices. Jeanne Lenzer and Shannon Brownlee, “Why the FDA can’t protect the public,” British Medical Journal, November 6, 2010. Lenzer is a medical investigative journalist, and Brownlee is an instructor at the Dartmouth Institute for Health Policy and Clinical Practice.
“Most devices and drugs on the market are supported by studies that are underpowered to detect rare but potentially life threatening events that can kill tens of thousands of people if the drug or device is widely used,” the authors write. “The impracticality of conducting large scale clinical trials before approval for every drug and device places a burden on post-approval surveillance.”
The authors also note that “FDA’s ability to detect potentially unsafe devices is further hampered by the fact that many post-approval studies required as a condition of the device’s approval are not conducted or conducted so poorly as to be meaningless.”
FDA’s Manufacturer and User Facility Device Experience (MAUDE) database is its most “comprehensive source of information about the safety and effectiveness” of medical devices, the authors claim. But they cite several problems associated with this “imperfect tool,” especially “the fact that manufacturers—not the FDA or any other independent body—can decide whether the device is connected with a negative outcome.” Other alleged problems with MAUDE include (i) “the voluntary nature of the reports,” (ii) “fear of litigation by surgeons and others in a position to report the event,” and (iii) “failure by patients and healthcare providers to connect new medical problems with a device.”
In response to the report, an FDA spokesperson reportedly said that the agency considers “very seriously” post-approval device monitoring, that FDA has “a variety of initiatives underway to bolster postmarket surveillance” and that the agency is reworking its 510(k) premarket approval process for lower-risk medical devices. See Product Liability Law 360, November 5, 2010.