FDA proposes unique device identification system for medical devices

Thursday, July 5, 2012 12:11 PM

In response to requirements in legislation that passed Congress with broad bipartisan support, the FDA has proposed that most medical devices distributed in the U.S. carry a unique device identifier, or UDI.

A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups and conducted four pilot studies in the development of this proposed rule. The FDA is seeking comment on the proposal for 120 days.

"The safety of medical devices is a top priority for the FDA, Congress, industry and patients," said FDA commissioner Margaret A. Hamburg, M.D. "The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety." 

With certain exceptions, under the proposed rule, a UDI would include:

  • A device identifier—a unique numeric or alphanumeric code specific to a device model
  • A production identifier, which includes the current production information for a device

The FDA is proposing a risk-based, phased-in approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The FDA is proposing to exempt over-the-counter devices sold at retail; these devices generally have UPC codes in place.

A UDI is a unique numeric or alphanumeric code that acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number. This information will be contained in a publicly available UDI database and no identifying patient information will be stored in this device information center.

The proposed rule reflects the considerable input the FDA received from the medical device industry, the clinical community, patients, consumers and industry experts. To minimize industry costs and expedite implementation, the proposed rule builds upon current standards and systems already in use by some companies.

A UDI system could provide multiple benefits, including:

  • Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
  • Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
  • Provide a consistent way to enter information about devices in electronic health records and clinical information systems.
  • Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
  • Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
Share:          
CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs