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Unique device identifier (UDI)
Improving safe and effective use of medical devices

Medical device identification and need for UDI
Advancing Patient Safety Coalition pushes for UDI rule
Congress passes UDI language
Premier's input to FDA

Medical device identification and need for UDI

Patients today face a significant risk that a recalled or defective medical device could be used in their treatment because of the lack of consistent and reliable methods for a hospital or physician to quickly and reliably identify such devices. The unique medical device identification (UDI) is the missing link to better ensure patient safety protection. See: Premier Position Statement on medical device identification (February 28, 2011)

The FDA Amendments Act (Section 226) of 2007 directed the FDA to issue regulations establishing a UDI system for medical devices to provide early detection of defective devices and facilitate device recalls to enhance patient safety and reduce medical errors. Healthcare advocates are urging FDA to finalize a UDI regulation to speed its adoption and use.

Advancing Patient Safety Coalition promotes UDI legislation Premier has led a collaborative effort through the Advancing Patient Safety (APS) Coalition along with more than 40 major healthcare-related associations in Washington to promote the unique device identifier (UDI) of medical devices. These efforts involve communications with the Food and Drug Administration (FDA) and Congress. See press releases.

Bar coding of drugs and biologics sets the stage for UDI. The FDA’s final rule, effective February 26, 2004, requiring bar codes on the labels of thousands of human drugs and biologic products by 2006, represented a far-reaching initial step to harness information technology to protect patients from medication errors. The next step is the identification of medical devices with a unique device identifier. Comments solicited by the FDA during rulemaking for bar coding of drugs and biologics, as well as recent public meetings, will be used to address a rule on unique identification of medical devices. See bar coding.

Advancing Patient Safety Coalition pushes for UDI rule

The Food and Drug Administration (FDA) continues to explore implementation of a unique device identifier (UDI) for medical devices and solicited input from stakeholders. On August 11, 2006 FDA published a "Request for Comment" on how a national UDI system should be structured and how it would improve patient safety, reduce medical errors, facilitate device recalls and improve device adverse event reporting. The FDA passed a proposed rule "FDA Amendments Acts of 2007" following the 2006 comments. Premier continued its work with the coalition and the FDA to promote the adoption of a UDI. The coalition continues to press the FDA to finish the proposed rule and implement UDI rule. The most recent activity of the ASP coalition was a letter sent to the Office of Management and Budget (OMB) requesting a release the proposed rule on the unique device identification (UDI) system for medical devices. Selected materials and resources follow, to provide background work leading up to the current status (2011) of the MDI/UDI.

Congress passes UDI language

The Senate unanimously passed a bill (9/21/07) that includes a provision requiring the Food and Drug Administration (FDA) to put into place a unique medical device identification system. The House approved the same bill earlier (9/19/07) which would reauthorize user fee programs under the FDA and expand FDA's authority to monitor medical devices and prescription drugs.

The unique device identification (UDI) language
The FDA Amendments Act of 2007 (H.R. 3580)
Rep. Darlene Hooley (D-OR) floor speech during House debate of the bill

Talking points

Talking points to address FDA's request for comment (10/06)

House Members call for UDI to improve patient safety

Premier's input to FDA

Premier's comment on FDA’s efforts to implement UDI, February 27, 2009

Premier urged the Food and Drug Administration (FDA) to move forward immediately in issuing regulations for a mandatory unique device identification (UDI) system that is globally harmonized and offered specific recommendations on how to develop such a system. In its response to FDA’s request for comments, Premier underscored the need for a UDI system to advance patient safety by improving processes for device recalls and corrections, strengthening the ability of the FDA and manufacturers to monitor adverse events and maximizing the value of electronic health records. Premier submitted formal comments to the FDA on November 9, 2006.

Safety Institute Device Recall Survey results

On October 20, 2006, a "device recall survey" was sent via e-mail to the subscribers of the SafetyShare® newsletter. The survey was part of Premier's effort to gather information on the current methods used in healthcare settings to record and track information on medical devices.

It was noted in the request for participation that the information gathered in the survey would be shared with the FDA as additional insight into how a unique device identification (UDI) system may improve patient safety by facilitating device recalls and improving medical device adverse event reporting. Premier submitted the survey results with its formal comments to the FDA on November 9, 2006.

Unique device identifier (UDI) Improving safe and effective use of medical devices