According to a British Medical Journal, 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.
The article is published by Jeanne Lenzer and Shannon Brownlee, called “Why the FDA can’t protect the public,” on 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.
That FDA response comes little more than two weeks after the FDA rescinded approval of the Menaflex Collagen Scaffold knee replacement device. The agency admitted that the medical device was approved without being properly researched due to political pressure and the overly flexible requirements of a program designed to fast-track certain devices through the approval process.
It also comes just three months after DePuy Orthopaedics issued a recall for 93,000 artificial hips, which had failure rates of 12% and 13%. Many individuals who received one of the defective hips are pursuing a DePuy hip lawsuit, alleging that doctors were expressing concerns to DePuy about a higher-than-expected failure rate for the metal hip system before the recall. The implants have been found to shed metal particles into the bloodstream, which could lead to cobalt toxicity.
A study by the Government Accountability Office (GAO) released in June 2009 found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identified gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.