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Tackling a framework for surgical innovation
Date:6/18/2013

NEW YORK (June 18, 2013)-- An international team of investigators co-led by Weill Cornell Medical College is offering a new framework for evidence-based surgery and device research, similar to the kind of risk and benefit analysis used in evidence-based medicine.

"Currently, there is no dynamic research framework to systematically detect devices and surgeries that don't offer any benefits to patients or may even be harmful," says co-lead investigator Dr. Art Sedrakyan of Weill Cornell Medical College.

In the June 18 issue of the British Medical Journal (BMJ), Dr. Sedrakyan and his colleagues suggest ways that clinical trials, observational databases and registries can be used to provide quality assessment and surveillance of both surgery and the use of implanted medical devices.

"The failure to conduct methodologically rigorous studies has led to some devices/surgical interventions, such as metal-on-metal hip implants or robotic surgery, becoming popular without high quality supporting evidence," says Dr. Sedrakyan, associate professor of public health and cardiothoracic surgery at Weill Cornell. Dr. Sedrakyan worked with a team of researchers from the United Kingdom, and U.S. Food and Drug Administration (FDA) who are part of the IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) Collaboration. This group is working on ways to improve research in surgery and on medical devices as a way to spur surgical excellence, as well as innovation.

At Weill Cornell Medical College, Dr. Sedrakyan leads the Medical Device Epidemiology Network's Science and Infrastructure Center, one of two FDA-funded centers in the country that evaluates medical devices, especially implantable devices. He is the vice-chair of the IDEAL Collaboration advancing device evaluation and, prior to joining Weill Cornell, has worked on post-market surveillance and modernization surveillance at the FDA.

Regulatory agenci
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Contact: Gerard Farrell
gerard.farrell@hkstrategies.com
646-317-7401
Weill Cornell Medical College
Source:Eurekalert

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