Unique device identifiers (UDIs) are labels placed on medical devices that can be read both by humans and computers. Source: fda.gov
By Haley Hinkle
WASHINGTON—The U.S. Food and Drug Administration plans to launch a new system for analyzing the effectiveness of medical devices after they hit the market and are put in use across the country.
The system, planned in collaboration with Brookings Institute’s Engelberg Center for Health Care Reform, is supposed to help both the public and private health care sectors collect data on patient experiences with pacemakers, orthopedic implants and other devices.
This information can then be used to update regulations and quickly develop medical devices based on real patient experience, allowing manufacturers, doctors and patients to make decisions looking at available data.
Ultimately, the goal of the new system is to evaluate patient experiences in order to improve existing products and create new ones. Kathy Blake, a member of the FDA-Brookings planning board of public and private health care professionals, said individualized data on implants would allow the health care system to keep up with industry trends.
Blake, a director at the American Medical Association, said the country is moving towards a “learning health care system” – one that stores patient information which can be used for individualized medical response.
The FDA-Brookings planning board has not laid out specific recommendations for the data collection.
The FDA’s Jeff Shuren said during a news conference Monday that better data and improved methods for analyzing observational patient experience with medical devices have created the opportunity.
After devices have been sent out “into the wild” for use, it is much harder to gather clinical data on them, so the challenge is learning how to capture that information, said Shuren, director of the Center for Devices and Radiological Health at the FDA.
“If we do that, we can fundamentally change the way medical devices are introduced in the U.S.,” he said.
One of the more recent technological developments is the use of unique device identifiers (UDIs) on all medical devices. UDIs labels can be read by both humans and computers.
In order to The key to making the proposed system work is to tie the device identifiers back to the individual patient’s identity, said Lewis Sandy, an executive vice president at UnitedHealth Group.
Now that the FDA and Engelberg Center’s planning board have made recommendations, health care professionals plan to launch a pilot program to test and improve methods of device data intake and analysis.
