View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
January 4, 2010

Medical Device Approvals Lack Scrutiny, Study Finds

Many cardiac devices are not subject to rigorous safety and effectiveness research before being approved for use, new research has found. A study by UC San Francisco found that implanted cardiac devices such as pacemakers and stents are receiving US Food and Drug Administration approva

By cms admin

Many cardiac devices are not subject to rigorous safety and effectiveness research before being approved for use, new research has found.

A study by UC San Francisco found that implanted cardiac devices such as pacemakers and stents are receiving US Food and Drug Administration approval based on data from just one trial, questioning the quality of data, according to a report in the Journal of the American Medical Assocation.

Co-author of the paper and medical resident Dr Sanket Dhruva said that drugs have been given far greater attention than medical devices by the safety agency.

“We didn’t expect that all the devices would need multiple studies or randomised studies. But we were surprised that so many devices were approved on the basis of a single study,” Dhruva said.

The study found that 65% of the pre-market approval applications for high-risk devices were supported by a single study while only 27% of the studies were randomised and only 14% were blinded.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Get important industry news and analysis sent to your inbox
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Hospital Management