5 Leading Healthcare Organizations Request Release of FDA's Proposed Rule on Unique Device Identifiers (UDIs)

Scituate, MA (March 1, 2012): A group of health care organizations, all committed to improving efficiency in the healthcare supply chain, submitted a letter to the Office of Management and Budget (OMB) on February 16 2012, urging the expeditious release of the Food and Drug Administration’s (FDA) proposed rule on Unique Device Identifiers (UDIs) so that public comment may commence as soon as possible.   The proposed FDA rule, under review at OMB, is expected to require many medical device manufacturers to use UDIs, numerical codes intended to identify medical devices used in a variety of processes and applications throughout the health care industry. 

The associations that submitted the letter are:

In their letter to OMB Acting Director Jeff Zients, the organizations explain that they believe the rule warrants public and industry debate and comment.   Since the UDI protocol was mandated in the Food and Drug Amendments Act of 2007, the organizations urged the OMB to move the regulatory process forward and allow for public comment. In part, their joint letter stated, “The great potential for UDIs to increase safety and lower costs for the American healthcare system means that widespread adoption is sorely needed now. Prompt action is also important because hospitals and physicians are in the process of implementing electronic health records as part of the Medicare and Medicaid EHR Incentive Programs. Ideally, those significant new systems should incorporate the capacity to capture and use UDIs.”

According to Tom Hughes, Executive Director of SMI,   “SMI’s member organizations, both providers and suppliers, join our association colleagues in requesting that the FDA rule be released. Until the rules about unique device identification are known and understood, meaningful actions to implement UDI cannot take place.”

A copy of the letter can be found at: http://www.smisupplychain.com under Tools.