Unique Device Identifier (UDI) for medical devices-resources
The Food and Drug Administration (FDA) is exploring 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 with comment due by November 9, 2006 on how a national UDI system should be structured and how it will improve patient safety, reduce medical errors, facilitate device recalls and improve device adverse event reporting. Premier facilitated working with other organizations and the FDA to promote the adoption of a UDI. Premier continues to lead a collaborative effort with major healthcare-related associations in Washington to promote the unique device identifier (UDI) of medical devices. Selected materials and resources are provided below.
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
House Members call for UDI to improve patient safety
- UDI language - incorporated into legislation reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA)
- Letter of support from APS coalition to committee supporting the language (6/18/07)
- Statement from Rep. Darlene Hooley (D-OR) - UDI to improve patient safety (6/21/07)
House Members call for unique medical device identification to improve patient safety (5/10/07)
- Download the APS coalition letter Congress to FDA (5/7/07)
- Download the APS coalition letter to Congress (3/6/07)
- Download the APS members
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.