In the last 15 years, the FDA approved several high-risk devices for obstretric and gynecological procedures that were insufficiently tested before receiving approval, according to researchers at Northwestern University's Feinberg School of Medicine.
The Evanston, Ill.-based researchers reviewed trial data and approval process records for 18 devices representing the highest potential risk to patients, ranging in use from contraceptives to endometrial ablation, that were approved by the FDA between January 2000 and December 2015.
Of the devices, 11 went through randomized controlled trials, five had nonrandomized prospective studies, two were human factor studies and one had a randomized crossover study. While 14 of the 18 devices met efficacy goals set for the trials, only 12 out of the 18 received postmarket surveillance. Researchers claim some of these devices received no follow-up after approval, even with reports of significant adverse health affects including pain, organ damage and unintended pregnancy.
Since gaining approval, three of the devices are now withdrawn from the market, two failing to show efficacy in their clinical trials and one removed due to patient safety concerns.
"There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices," Steve Xu, MD, a researcher at Northwestern University, said. "Requirements are decided on a case-by-case basis. There are much higher standards for the approval of new drugs, whether oral, injectable or even topical. The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?"
More articles on supply chain:
Healthcare Supply Chain Association names Vizient's Ricki Wilson chairperson for healthcare division
Eli Lilly plans to launch 20 new drugs by 2023
Entellus Medical names CFO