The United States is in the process of improving how it tracks medical devices and the patients who use them on a systematic level.
As a result, regulators are lobbying for the establishment of an effective National Medical Device Surveillance System in order to properly and efficiently track devices.
The recent passing of regulations calling for the implementation of a Unique Device Identification (UDI) number for almost all devices marketed in the U.S should help expedite this process should the surveillance system initiative move forward.
A “21st Century” medical device surveillance system will provide easier access to electronic health records and databases, in addition to the pros, cons, and overall performance results of most of the medical devices in America.
FDA’s Center for Devices and Radiological Health (CDRH) Director Jeffery Shuren posted on FDA’s Voice blog, the new system will leverage “new tools and systems unimaginable a generation ago,” giving regulators “real-time data about what happens to patients in clinical practice.”
“We will be able to leverage these capabilities not only to quickly identify poorly performing devices, but also to facilitate device approval/clearance and patient access, to reduce postmarket data collection for manufacturers, and to better inform healthcare decisions by providers and patients alike,” Shuren added.