Devices approved 1st in the EU linked to more safety issues than approved US devices: 4 insights

Spinal Tech

A new study, published in The BMJ, examines safety alerts and recalls of medical devices first approved in the European Union and then, subsequently, in the United States.

Researchers searched:


•    Public and commercial databases for press releases and approval announcements
•    Public FDA and European regulatory authority databases for U.S. approvals and safety alerts and recalls
•    Medline, Embase and Web of Science for peer-reviewed publications


During the study period, the European Union approved 309 cardiovascular, orthopedic and neurologic devices. The United States approved 67 percent of those 309 devices.


Here are four insights:


1. Of the 67 percent, the European Union approved 63 percent first.


2. The unadjusted rate of safety alerts and recalls for devices first approved in the European Union was 27 percent compared with 14 percent for devices the United States first approved.


3. The adjusted hazard ratio for safety alerts and recalls was 2.9 for devices approved first in the European Union.


4. Devices approved first in the European Union are associated with an increased risk of post-marketing safety alerts and recalls as compared to devices receiving approval in the United States first.


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