November 7 Comment Deadline for FDA’s Unique Device Identification Rules: Three Key Points

Three Key Points

November 6, 2012

In July of this year, FDA proposed rules for a Unique Device Identification (UDI) System. All comments on the proposed rule are due by Nov. 7, 2012. The purpose of the rule is to reduce existing obstacles to identifying specific medical devices and reduce medical errors resulting from misidentification of a device or confusion about its appropriate use. Upon finalizing the rule, FDA plans a staged implementation over the next seven years. Below are three key points about the regulations and the potential benefits of the UDI system.

  1. Integration. The level of benefit achieved by a UDI system will depend on the level of adoption of other federal government programs, including the adoption of electronic health records (EHRs). Scanning the UDI bar code on a device and placing the information in a patient’s EHR will link critical patient information (such as latex sensitivity) with specific medical device information. Also, the proposed federal pharmaceutical track-and-trace legislation released on Oct. 24, 2012, which aims to decrease the time necessary to trace adverse events and decrease susceptibility of the pharmaceutical supply chain to counterfeit products, could coordinate with the UDI system to achieve mutual aims. UDIs could help reduce the potential injury from counterfeit devices by offering a better way to detect a counterfeit product and remove it from the market. Globally, the FDA aims to have the UDI system harmonized with other international regulatory tracking systems.
  2. Applicable Devices. The UDI requirements will apply to all medical devices except for OTC devices and certain Class I devices, including devices exempt from the FDA Good Manufacturing Practice requirements. Overall, the vast majority of medical devices would require UDIs, and if the medical device can be separated from its label, as in the case of implantable devices, the UDI would have to be printed onto the device.
  3. Stakeholder Benefits. An Oct. 25, 2012, article in the New England Journal of Medicine (NEJM) enumerated a variety of ways the UDI system will benefit all stakeholders in the healthcare system. These benefits include:
    • permitting more accurate and timely reporting and analysis of adverse events;
    • rapidly and precisely identifying the specific device that is subject to recall;
    • facilitating post marketing evaluation of new devices; and
    • potentially expanding the use of existing devices.

Thomas. P. Gross, M.D., M.P.H., and Jay Crowley, M.S., “Unique Device Identification in the Service of Public Health,” NEJM 2012; 367: 1583 (Oct. 25, 2012).