FDA seeking comments on the new UDI device monitoring system

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Thanks Lana! Looks like there will be an identifying tag going into breast implants! That should stop ebay sales - after the unidentified ones are going . . . And the reuse of implants . . . But, I wonder if, whatever they use, will be safe? Rogene ------------------------------Lana Transue <lanadearest@...> wrote: From: "Lana Transue" <lanadearest@...>saxony01@...Subject: FDA seeking comments on the new UDI device monitoring systemDate: Sat, 12 Aug 2006 09:14:49 -0700FDA NewsFOR IMMEDIATE RELEASEP06-112August 9, 2006Media Inquiries:Heidi Valetkevitch, 301-827-6242Consumer

Inquiries:888-INFO-FDAFDA Seeking Comments on Use of Identifier System for Medical DevicesIdentifier System Could be Important Tool for Patient SafetyThe Food and Drug Administration (FDA) is seeking information on how the use of a unique identifier system for medical devices may reduce medical errors, facilitate device recalls and improve medical device adverse event reporting.A notice will appear in Friday's Federal Register (www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm). The agency is seeking public comment for the next 90 days. A public meeting is planned in the fall; FDA will provide details when they become available. The comments will be used to help the agency determine what next steps the agency should take related to a unique device identifier (UDI) system for medical devices."Much like the bar code rule for drugs and biological products, unique identifiers for medical devices could have many

potential benefits for improving the quality of care for patients," said Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. "A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency."The number and complexity of medical devices is growing. It is important for FDA to quickly identify new risks and work with industry and device users to manage these risks appropriately. A UDI system may be used to identify a device and the information associated with that device throughout its lifetime. For example, a UDI could identify which devices are compatible, such as implanted devices being used safely with magnetic resonance imaging (MRI) systems.Over the past year, FDA met with various

stakeholders and found that most supported the development of a UDI system as a way to improve patient safety. FDA also learned from the meetings that stakeholders recognize that such a system could provide supportive benefits, such as better management of the purchase, distribution and use of medical devices.FDA also commissioned two reports from outside experts on automatic and unique identification of medical devices. The reports identified several potential benefits of a UDI system, including identifying incompatibility with devices or potential allergic reactions. In addition, FDA has been working with the Agency for Healthcare Research and Quality (AHRQ) in the U.S. Department of Health and Human Services (HHS) and with other federal partners to better understand the issues with the development, implementation and use of a UDI system."It is essential that we monitor the performance of medical products after

they are approved and make sure that we quickly discover any potential problems that might arise," said C. von Eschenbach, M.D., Acting Commissioner, FDA. "To improve our postmarket data collection at FDA, we are using a total product lifecycle approach to how we look at medical devices and focusing more attention on the kinds of systems and processes we need to have in place to monitor products after they are approved."During the comment period, FDA wants to learn about the feasibility, utility, benefits and costs associated with developing and implementing a UDI system for medical devices. In addition, the agency wants to hear about various automatic identification technologies, such as bar code and radiofrequency, which could be used with a UDI system. A list of questions as well as what a UDI could look like, are included in the Federal Register notice.To submit electronic comments, visit

www.fda.gov/dockets/ecomments . Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must be received by Nov. 9 and include the docket number 2006N-0292.For more information, visit www.fda.gov/cdrh/ocd/udi/index.html.