FDA to Release Plan for Device Identification System
The U.S. Food and Drug Administration (FDA) will assign medical devices unique identification numbers in an effort to improve patient safety. Most devices—such as catheters, defibrillators, heart stents and artificial joints—fall under the plan, but there are some devices that will be excluded from this program. It isn’t clear what kind of devices those will be.
A unique device identification (UDI) system was mandated in 2007 by the U.S. Congress, but it has not as yet been implemented. The FDA user fee bill that was passed in Congress in June (Medical Device User Fee and Modernization Act) contains language mandating the FDA implement such a system within the next two years.
The UDI program may cost as much as $68.4 million per year, according to a pending rule proposal available to the public on the FDA website.
"These regulations are long overdue and are critical for protecting patients from faulty and dangerous medical devices," said Lisa Swirsky, senior policy analyst for Consumers Union, the policy and advocacy division of Consumer Reports. "Effective post-market surveillance of medical devices depends on having UDI in place. Once it is fully implemented, this system will enhance the FDA's ability to identify problem medical devices more quickly and inform patients when their safety is at risk."
Consumer Reports is a consumer and patient advocacy watchdog organization that has been critical of the medical device industry lately.
Identifiers would include bar codes and other technology, and they would help identify a range of details of the device in question such as batch number, serial number and expiration date. The UDI would also help regulators trace and track flaws, failures and incompatibilities before the risk becomes too great—and manage recalls better. On its website, the FDA says that its UDI system has the potential to lead to a global standard for medical device identification.
The FDA also announced a database would be made available for consumers to look up general information on medical devices. The database will not include any personal information such as who uses a device.
The FDA will publish the proposal in the Federal Register within one week. Companies then will have 120 days to submit any comments, suggestions or requested changes.