Safety risks from medical devices should be made clearer to patients, according to an analysis published today.
"In the EU, medical devices are approved by private notified bodies if they meet performance criteria and are likely to be safe, but notified bodies generally do not require evidence of effectiveness for most devices," write Dr Thomas Hwang of Harvard University, USA, and colleagues in the BMJ.
"Controversy over the safety of implanted devices approved without rigorous clinical testing has led to calls for regulatory reforms in the EU and US," they add.
In order to evaluate the current situation regarding safety alerts and recalls of medical devices, the team gathered information from public and commercial databases. This showed that 67% of the 309 devices identified were approved in both the US and the EU, of which 63% were approved first in the EU.
The analysis found a 27% rate of safety alerts and recalls for devices approved first in the EU, and a 14% rate for the US.
"Devices approved first in the EU are associated with an increased risk of post-marketing safety alerts and recalls," the authors write. "Poor trial publication rates mean that patients and clinicians need greater regulatory transparency to make informed decisions about treatment."
They add that this study "provides an important empirical measure of the trade-offs associated with the US and EU frameworks for regulating medical devices".
"Patients and clinicians need access to, and balanced presentation of, the available evidence of the safety and effectiveness of novel devices, as well as clear communication about the evidentiary gaps," they conclude.
Hwang, T. J. 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 28 June 2016 doi: 10.1136/bmj.i3323 [abstract]
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