Healthcare Standards

 

UDI

UDI refers to a government initiative, a Unique Device Identifier system for medical devices. On September 27, 2007, the Food and Drug Administration (FDA) Amendments Act of 2007 was signed into law. This act includes language related to the establishment of a Unique Device Identification system.

On July 10, 2012, the U.S. Food and Drug Administration (FDA) issued a proposed rule implementing a 2007 statutory requirement to establish a unique device identification system for medical devices. The rule would phase in over seven years a requirement that many device labels and packages include a unique device identifier (UDI) based on international standards.

Under the rule, some devices would need to be marked directly with the UDI, such as those that are implanted or are likely to become separated from their labeling. Each UDI would be provided in both plain-text and in a form that uses automatic identification and data capture technology, such as a barcode. In addition, information about each device would be submitted to a public database maintained by the FDA. Hospitals and other healthcare providers could use the UDI to more easily track the devices, but are not required to do so. The rule also proposes a standard format for presentation of dates on medical device labels.

Comments on the proposed rule will be accepted through November 7 at http://www.regulations.gov or directly to the FDA as outlined in the proposed rule.

A unique medical device identifier would provide an important means for hospitals to better track medical devices for use in patient care, act in event of safety recalls, and manage their supply chains. UDIs also can be incorporated into electronic health records. The accompanying information maintained in the FDA's proposed public database, the Global Unique Device Identification Database, would be an important, centralized source of basic information on medical devices. According to the FDA, the system also would help reduce medical errors and help identify and correct problems relating to a particular device sooner.

The FDA is seeking comment on the proposal for 120 days, until November 7. To help clarify some of the items included in the proposed rule, on July 31, 2012, AHRMM hosted a webinar with Jay Crowley, a Senior Advisor for Patient Safety, in FDA's Center for Devices and Radiological Health. The webinar, entitled Unique Device Identification (UDI) – Enabling the Transformation of Medical Device Safety is available free of charge for AHRMM members and for $99 for non-members. To acces the webinar, click here.

The FDA completed a pilot test of a prototype UDI Database (UDID). The purpose of the pilot was to better understand the data attributes and assess the feasibility and usability of the UDID. We were especially interested in manufacturer's ability to identify and organize the data and load it into the database as well as user’s ability to use, retrieve and export the information. The report is available here.

For additional information please read the following 2-part series on UDI:
From Information Silo to Bridge, Part 1: The State of UDI, Medical Device & Diagnostics Industry
From Information Silo to Bridge, Part 2: Creating a UDI System, Medical Device & Diagnostics Industry

News

Useful Links

Correspondence

Advancing Patient Safety Coalition's letter to Sen. Jeff Merkley expressing strong support for the Ensuring Safe Medical Devices for Patients bill.

AHRMM and Four Other Leading Healthcare Organizations Request Immediate Release of the FDA's Proposed Rule on Unique Device Identifiers (UDIs) - RIN: 0910-AG31

AHRMM's correspondence to the FDA on the subject of Unique Device Identifiers

Advancing Patient Safety Coalition's (APSC) correspondence to the FDA

 

 
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