Scientists propose a framework for more comprehensive assessment of medical device safety and efficacy
- 14 June 2016
Every medicine we take has been extensively trialled to prove it is safe and it works, but the same standards do not necessarily apply to medical devices like joint replacements, surgical mesh or pacemakers.
Now, a group of researchers led by Oxford University and Weill Cornell Medicine have proposed a new framework to make sure that such devices get better scrutiny.
Writing in the June 9 issue of BMJ, the researchers compare the existing approaches to evaluation of medical devices in both the United States and the European Union — where manufacturers have to prove only that a device is safe to get approval to sell it — with an integrated evaluation pathway for demonstrating that devices are both safe and effective.