Unique Device Identification (UDI) ...What Others are Saying... “The FDA and the Secretary of HHS, Secretary Leavitt, really strongly support the development of unique identifiers for medical products. For the FDA, this has to do with the use and, of course, recalls, tracking, identification of adverse events and so forth.” FDA Deputy Commissioner Janet Woodcock Comments made at FDA’s public meeting on UDI (Oct. 25, 2006)   “The FDA played a crucial role in developing a numbering scheme for pharmaceuticals (i.e., National Drug Code or NDC) that has resulted in improved patient safety and significant cost savings in both human and financial capital. We see the FDA playing the same role to bring order and utility to the medical/surgical commodity. The systems should be mandatory for all manufacturers and any organization that repackages these items for resale or distribution.” Written comments from Department of Defense to FDA in response to Request for Comments (Nov. 9, 2006)   “I think comparison of effectiveness between devices is an important issue for Medicare in that we want to see an increase in value for the health care dollars spent. . . This [UDI] would help us get the data and understand, I think the effectiveness and benefits the patients are getting.” Dr. Marcel Salive, Centers for Medicare and Medicaid Services Comments made at FDA’s public meeting on UDI (Oct. 25, 2006)   “Electronic health records and health IT generally speaking, there has been a lot of activity in the federal space over the past two years. . . UDI can plug into that . . . There’s also a quality measurement movement that’s been happening at the federal level as well . . . But I think there’s a real opportunity for the folks in this room to be leaders and to anticipate that and be ready and do some really good things ahead of time.” Dr. Jon White, Agency for Healthcare Research and Quality Comments made at FDA’s public meeting on UDI (Oct. 25, 2006)   “The UDI system would be a worthwhile investment because of its effect on patient safety. She noted how it can be difficult and time-consuming to locate devices throughout her system when there's a recall. However, one of her concerns is that organizations such as Bon Secours might start investing in a UDI system and then final federal regulations would require a different type of system to be put in place.” Michelle Allender, director of clinical resource management, Bon Secours Health System, Inc. Quote from Modern HealthCare (Jan. 22, 2007)   “We buy devices. We apply new numbers and new stickers. We bind the things together in our homegrown database— it’s terribly inefficient, and it’s a good source for errors. It prevents the collection of data at a national level for national investigations and for pursuing potential device problems.” Dr. Julian Goldman, Partners Healthcare Comments made at FDA’s public meeting on UDI (Oct. 25, 2006)   “What are the public health and patient safety benefits to a unique device identification system? A better ID of devices in adverse events, more rapid and accurate recalls and enhanced capability for post-market surveillance.” John Eyraud, Eastern Research Group, Inc. Comments made at FDA’s public meeting on UDI (Oct. 25, 2006)   “A synchronized master file of UPN will enable the use of bar coding throughout the healthcare supply chain to increase patient charge accuracy and reduce medical errors.” Written comments from the Coalition for Healthcare eStandards to FDA in response to Request for Comments (Nov. 9, 2006)