EU Device Approval Always a Win? Not So Fast

New findings published by The BMJ may give some proponents of speedy device approvals pause. It's well-known that high-risk medical devices often win approval or clearance more quickly in the European Union than from FDA. But those fast approvals and clearances may come at a price. 

Data from a cohort study shows that medical devices first approved in the European Union had almost triple the rate of safety alerts and recalls, according to authors of the study, "Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States."

The findings come at a time when regulators around the world have been considering the pros and cons of various approval processes for devices. There are efforts in the United States to streamline the FDA device regulatory process while the European Union is working to update its device and IVD rules.

Researchers from the United States--Harvard University, Harvard Medical School, and Brigham & Women's Hospital--and the King's College London in the United Kingdom found a total 309 new medical devices were approved in the European Union between 2005 and 2010. Of these, 75 (24%) devices were considered major interventions. Two-thirds of the 309 devices (206) were also approved in the United States and 63% of these (129 devices) were first approved in the European Union. 

The authors found that nearly a quarter of the devices (73 devices) had a recall or post-marketing safety alert. When analyzed using multivariable Cox regression modeling, the devices approved first in the European Union had a 2.9-fold higher rate of safety alerts and recalls and a 4.6-fold higher rate of recalls compared to those devices that received FDA approval first.

"Our findings suggest that products introduced earlier in their development cycle are also more likely to increase the risk of harms, underscoring the urgent need for transparency to make truly informed decisions," the study authors wrote.

There were published pivotal trial results for just 37 (49%) of those 75 devices considered major interventions. 

The authors called for a public database of all CE-marked devices and decisions, as well as approaches that might offer both safer and speedier commercial access, such as combining higher evidence requirements with a faster reimbursement process.

Of course, these findings aren't proof that FDA has taken the perfect tack to regulation, either. A study published in May found that FDA requirements for obstetrics and gynecologic devices approved over the past 15 years were not tough enough.

[Image courtesy of ANANKKML/FREEDIGITALPHOTOS.NET]