Many high-risk medical devices obtain Food and Drug Administration (FDA)
market approval after only one study, according to a new report. As
San Diego product liability lawyers, the findings raise concerns about the safety and efficacy of the devices.
The study, which was recently published in the
Journal of the American Medical Association, examined 28 high-risk devices approved in 2010 and 2011 via the FDA Premarket
Approval process. The approval process, which is intended to be more rigorous,
is required for devices that support or sustain human life or present
potential unreasonable risk to patients.
On average, the FDA relied on one study per device to determine market
approval. While the agency required 33 postmarket studies for the 28 devices,
only six had been completed as of October 2014. As
Reuters reports, five devices were not supported by any postmarket studies, while 13 others
had three or fewer postmarket studies. Most concerning, 10 of the 28 medical
devices studied were ultimately recalled.
As the study authors highlight, the failure to examine the safety of high-risk
medical devices after they enter the market could put patients at risk.
“Medical device regulation in the U.S. is well known to be more
rigorous than in other parts of the world,” said senior author Dr.
Joseph S. Ross of the Yale University School of Medicine in New Haven.
“The difference is, in many European countries they have much better
capacity to follow devices once they are in practice. They allow devices
on the market quicker in the U.K., but follow the devices so they can
observe them in practice.”
In light of the study findings, doctors and patient safety advocates are
calling on the FDA to more closely track the performance of medical devices
after they enter the market. They point to the FDA’s plan to require
unique device identifier codes as a good start.
If you or someone you love has been seriously injured by a dangerous or
defective medical device, don’t hesitate tocontacta San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.