New research suggests that if a medical device hits the market in Europe before it is approved by U.S. regulators, it may undergo less rigorous screening before it is allowed to be used on Americans, and may be more likely to turn out to carry dangerous risks.
In a study published in the medical journal The BMJ, researchers from Harvard and King’s College London found that medical devices were twice as likely to be the subject of a recall if they were approved in the European Union before being approved in the United States.
Researchers looked at the difference between how high profile medical devices first approved in the EU performed in the U.S., comparing the devices to those that were approved in the U.S. first.
Regulators in the United States have a much more rigorous approval process and a very different bar for allowing medical devices onto the market, but approval of a product in the E.U. appears to make it easier for manufacturers to obtain approval in America in many cases.
“In the EU, devices can be marketed if they perform ‘as intended’ and are likely to be safe; clinical testing may be required for some high risk devices,” the researchers said. “By contrast, in the US, high risk devices must demonstrate reasonable assurance of safety and effectiveness before they can be used by patients, generally through the conduct of prospective clinical trials.”
Because of the more lax approval requirements in the EU, many devices are approved there more rapidly, and that approval gives weight to their validity when seeking approval in the U.S. The researchers note that, for example, the first transcatheter aortic valve replacement was approved in the EU in 2007, but not in the US until 2011, the same year that the device’s actual effectiveness was shown in a clinical trial.