"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", stated Daniel 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 United States 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", stated Andrew 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.