A group of health care organizations have written a letter to Jeff Zients, Acting Director of the Office of Management and Budget (OMB), asking for the release of FDA's proposed rule on Unique Device Identifiers (UDIs). According to FDA, Section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) directs FDA to issue regulations establishing a UDI system for medical devices. This system is intended to improve the identification of devices throughout distribution and use.
The associations that submitted the letter are:
• Association of Healthcare Resource and Materials Management (AHRMM) - www.ahrmm.org
• Healthcare Supply Chain Association (HSCA) - www.supplychainassociation.org
• Health Industry Distributors Association (HIDA) - www.hida.org
• Medical Device Supply Chain Council (MedSC) - www.medsc.org
• Strategic Marketplace Initiative (SMI) - www.smisupplychain.com
Dated February 16, the letter states that the proposed UDI rule needs public and industry debate and comment. The groups write: “The undersigned organizations support the general use of UDIs in the health care supply chain." However, the groups report they "have not had the opportunity to review the specifics of the proposed draft rule that is under review at the OMB.
"The great potential for UDIs to increase safety and lower costs for the American healthcare system means that widespread adoption is sorely needed now," the letter continues. "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.”
A copy of the letter can be found on the Web site of Strategic Marketplace Initiative (SMI), a non-profit organization that states it is dedicated to improving the healthcare supply chain.
Tom Hughes, Executive Director of SMI, stated in a press release: “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.”