While the U.S. typically lags the European Union in medical device approval rate, a new study shows that devices first approved in the EU are linked to a greater risk of post-marketing safety alerts and recalls.
The researchers studied the publication of trial outcomes and safety alert and recall information for novel cardiovascular, orthopedic and neurologic devices that received a CE mark between 2005 and 2010. The majority of such devices were approved first in the EU and then in the U.S. The findings were published Tuesday in The BMJ.
They looked at a total of 309 devices, 206 (or 67%) of which were approved in both markets. Of these, 63% were approved first in the EU. While approximately one-quarter of the total devices studied were associated with safety problems after commercialization, those approved first in the EU--including products yet to receive U.S. approval--had a higher rate of safety alerts and recalls than those approved first in the U.S. The unadjusted rate for these safety issues was 27% (62 out of 232) for devices first approved in the EU compared with 14% (11 out of 77) for those approved in the U.S.
Companies typically seek a CE mark before FDA approval, as high-risk devices are approved more quickly in the EU than in the U.S. Devices can be marketed in the EU if they work “as intended" and clinical testing may only be required for certain high-risk devices. Meanwhile, in the U.S., high-risk devices must undergo safety and efficacy clinical trials before they are allowed for use in patients. As a result, patients in the U.S. may wait up to three additional years for access to devices that are approved in the EU, the researchers wrote.
They also studied the rate at which devicemakers published clinical trial results, finding that of the 75 devices they designated as “major innovations,” only 49% had published pivotal trial results. Five years after approval, the publication rate drops to 37%. This could be a factor in increased safety issues, as trial data could help clinicians make treatment decisions.
The study did have several limitations, such as the focus on three types of devices and the fact that CE marking does not guarantee instant access to the market, as companies must negotiate with individual countries on reimbursement. However, the researchers noted that it provided some insight on how the EU and U.S. regulatory systems could be improved.
They suggested that the FDA could cut down on delays by fast-tracking devices that could significantly improve patient outcomes, but tempered this with discussion of the risks of approving devices quickly. “[Patients] in the EU have substantially less and lower quality information on the potential benefits and harms of new devices, which raises some ethical concerns because CE marking may be interpreted as signifying that devices are safe and clinically effective,” they wrote. This can be addressed by stricter clinical data publication requirements and educating the public on what CE marking really means.