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New FDA rule requires unique identifier on medical devices

Premier Communications

Brought to you by the Premier Safety Institute®

Gina Pugliese, RN, MS, editor

September 23, 2013


New FDA rule requires unique identifier on
medical devices

UDIThe Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. The long awaited final rule will establish a system to identify devices through their entire distribution and use. The rule, released on September 20, 2013, finalizes a complete implementation of a national UDI system in stages over a period of seven years. When fully implemented, it will improve the quality of information in medical device adverse events reports by making it easier to identify devices. It will also allow the FDA, healthcare providers and industry to more quickly identify product problems and obtain key information to take appropriate and targeted corrective action and effectively manage the recall process to improve patient safety. It will also provide a standard and clear way to document device use in electronic health records, clinical information systems, claims data sources and registries. Research has shown that UDI can save as much as $16 billion annually by automating manual processes and improving efficiencies.

UDI on medical device label and package

A UDI is a unique numeric or alphanumeric code that includes a mandatory identifier – a different UDI is required for each version or model of a device. The system established by this rule requires the label and device package of a medical device to include a UDI in both plain-text and in a form that uses automatic identification and data capture (AIDC) technology. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be on the device itself. The identifier will include production-specific information, such as, the lot or batch number, the serial number and/or expiration date. All dates on device labels and packages are required to be presented in a standard format that is consistent with international standards and practice.

Searchable database to contain all UDIs

A publicly searchable database is being created by the FDA called the Global Unique Device Identification Database (GUDID) that will include a standard set of basic identifying elements for each device with a UDI. This will reduce medical errors by removing any confusion and being able to positively identify a device and its key attributes without having to access multiple, inconsistent and potentially incomplete sources for information. No identifying patient information will be stored in this database.

Initial focus on high-risk devices
The UDI system will be implemented in phases over seven years, focusing first on Class III high-risk medical devices and implantable, life-supporting, and life sustaining devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.

UDI – a foundation for a global medical device identification system
The FDA notes that UDI will also provide a foundation for a globally recognized medical device identification system, as well as a secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.



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