Medical Devices Approved More Quickly in EU Face More Safety Alerts and Recalls

Most cardiologists know that the medical devices they use in practice are more likely to first be approved by regulators in the European Union before they are cleared in the United States. Now a new analysis shows that the devices approved in Europe are also more likely to be subject to safety alerts and recalls—even if that information may not always be particularly easy to track down.  

“I think [patients] have the right to certain basic information about a device being implanted in [their] bodies or being used to further care, and I hope that our paper motivates policy makers to take a good look at why exactly information about these devices is being withheld. And if those reasons are not credible, I believe that the burden of responsibility of transparency should be on the manufacturers,” lead author on the study Thomas J. Hwang (Harvard Medical School, Boston, MA), told TCTMD. “I think more information should be provided to patients to provide informed decisions.”

Writing in the BMJ this week, Hwang and colleagues describe their intensive and unusual hunt through public and commercial databases to find announcements about cardiovascular, neurologic, and orthopedic devices approved in the United Kingdom between 2005 and 2010, as well as public FDA and European regulatory authority databases to find information on safety alerts and recalls. Finally, they also reviewed Medline, Embase, and Web of Science in order to find out which device approvals were supported by published clinical trial evidence and when those trials had been published.

Their review turned up some surprises. In all, 309 devices were identified as having received CE Mark approval in Europe during the study period, of which 245 (79%) were cardiovascular and 75 (24%) were considered “major innovations.” Of these 309, however, only 206 (67%) were also approved in the United States during this period: 21% via the strictest process—a premarketing approval (PMA) pathway—while 37% were approved via a supplemental PMA, 40% via the 510(k) pathway, and 2% as humanitarian use devices.

For devices approved in both countries, 63% were cleared first in the EU and the median time difference between approvals varied depending on the type of process followed in the US. For 510(k) clearance, the delay was just 1 month, but for a new PMA, the gap was 36.3 months.

Hwang and colleagues also looked at the timing of approvals in relation to publication of important clinical study data. For the 75 devices categorized as major devices, only 49% percent were the subject of pivotal trial results published in the peer-reviewed literature. Rates of publication ranged from 7% at 1 year postapproval in either the EU or US to 37% at 5 years.

That may be important, the authors note, because of the safety issues that emerge once the devices reach wider usage—things that might have been picked up in the big studies. In Hwang et al’s dataset, one in four of the devices studied was the subject of a recall or safety alert as of January 31, 2016, and, conspicuously, more safety issues were seen for devices approved in the EU but not, as yet, in the US (62 of the 232 devices, or 27%). By contrast, just 11 of 77 (14%) devices approved first in the US developed problems that prompted a recall or alert.

“Devices approved first in the EU were associated with a nearly threefold greater rate of safety alerts and recalls,” Hwang et al write.

Calls to Expedite US Approvals

Regulators in the United States have faced a growing chorus of calls to expedite approvals in order to get life-saving or life-changing devices to patients faster. By contrast, the European system has long been lambasted for placing expedited clearance above proof of efficacy and safety, prompting the European Commission to convene the Joint Action Plan of 2012, which led to new draft regulation still under negotiation.

To TCTMD, Hwang said there are messages in this study for regulators on both sides of the pond.

“There are ways that FDA could be more efficient in approving devices that have early rigorous evidence [of providing] substantial clinical benefit, so-called breakthrough devices,” Hwang said. “I think in some regards the EU does a good job of making sure that these devices are approved quickly. The downside, and the point of our paper, is that those benefits need to be carefully weighed against the risks of such an approach, because if you don’t differentiate the substantial clinical benefit [of some devices] from others, you also will get devices potentially on the market that have a higher risk or that are ineffective.”

On the other hand, the FDA has led the way in terms of making safety issues and clinical effectiveness data publically available. One of the provisions in the EU’s draft regulation is improved public access to safety and efficacy information, similar to what the FDA does now. “I think that would be an important step forward. Frankly it’s overdue and I think this should be perceived with some urgency,” Hwang said.

Indeed, one of the reasons a comparison of safety issues related to device approval timing hasn’t previously been studied relates to the difficulties in tracking down the data, he said. “Honestly, I was a bit surprised by our findings in that the magnitude of the difference [in frequency of safety complications] was quite large between devices approved in the US versus those approved in the EU.”

Other research by Matthew Grennan and colleagues has suggested that use of medical devices does not tend to pick up until after pivotal trial data are published, Hwang noted.

Even in the Europe, “devices that are approved before a clinical trial essentially aren’t used, and sales are poor compared to devices that go on to get FDA approval. Sales then pick up after clinical trial results are released,” he explained. “So [our paper questions] whether the EU approach is good for business, in addition to whether it is good for patients. And at least from the data [Grennan] and his team were able to put together, it seems like no. It seems that clinicians in Europe are understandably and justifiably waiting for the clinical results from the US to be conducted before they recommend that their patients is implanted with a device.”





  • Hwang reports receiving funding from Harvard University and the Interfaculty Initiative in Health Policy and was employed by Blackstone and Bain Capital. 




  • Hwang TJ, Sokolov E, Franklin JM, et al. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ. 2016;Epub ahead of print. 


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