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Should there be new national implementation of medical device evaluation? New report says yes.

It’s challenging to assess how safe and effective new medical devices are, which can be problematic concerning patient safety, but also for investors.

Thu Apr 07 2016By MedCity News

It’s challenging to assess how safe and effective new medical devices are, which can be problematic concerning patient safety, but also for investors.
 
A planning board for a national medical device evaluation system (NMDES) has now explained in a new report, “Enabling Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System,” how and why the U.S. should implement a network of partners that would be responsible for improving evidence-based results when it comes to proving a medical device’s efficacy. The goal is to improve patient outcomes and having organizations provide a more efficient system when using new devices.
 
The planning board, according to MedicalXpress, is made up of experts representing patients, clinicians, academic researchers, the medical device industry and others, and is supported in its work by the Duke-Margolis Center for Health Policy. Issues with understanding if a medical device is safe and actually works appropriately makes it challenging for clinicians to make fast, informed decisions. Not only that, it hinders the development of new devices and healthcare innovation.
 
The NMDES plans to give device manufacturers a faster, more predictable path to approval and health care coverage decisions. Once products are on the market, the NMDES will provide more cost-effective approaches to developing real-world evidence, which would give clinicians and insurers greater confidence in the products they use and health insurance payers would ideally benefit from better evidence to improve their coverage decisions.
 
To start, the project could include an incentive to improve and expand an existing medical device registry. This would be done by linking with other data sources or by creating a new virtual registry using EHRs and claims data on a some of the higher-risk devices, which potentially have serious but rare adverse effects.
 
This planning committee was reportedly inspired by a 2012 action plan by the FDA’s Center for Devices and Radiologic Health (CDRH).
 
 
 
This article was originally published on MedCityNews.
 
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