Update on Unique Device Identifier for Device Manufacturers

Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.

The reports further indicated that many issues have to be addressed prior to successful implementation of UDI for devices, including determining the technology needed to utilize UDI effectively, identifying the data needed for patient safety; development, maintenance, and validation of a central data repository; and harmonizing UDIs for the international marketplace. FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely into two categories: labeling and tracking. How does UDI fall into this category?

Why should you attend: Understand how the use of a unique device identification (UDI) system may improve patient safety, e.g., by reducing medical errors, facilitating device recalls, and improving medical device adverse event reporting. Understand some of the issues associated with the use of various automatic identification technologies (e.g., bar code, radiofrequency identification). On February 26, 2004, FDA published a final rule (the ``bar code rule'') (69 FR 9120 ) requiring bar codes on certain human drug and biological products to help reduce medication errors in hospitals and other health care settings. The bar code is intended to enable health care professionals to use bar code scanning equipment in conjunction with computerized medication administration systems to verify that the right drug, in the right dose, is being given to the right patient at the right time. This rule (now codified at 21 CFR 201.25 and 610.67) requires that manufacturers encode the unique National Drug Code (NDC) number in a linear bar code on the product's label. The bar code rule, however, does not apply to medical devices. In the bar code rule, FDA stated that, unlike drugs, medical devices do not have a standardized, unique identifying system comparable to the NDC number, and that the absence of such a system complicates efforts to put bar codes on medical devices for purposes of preventing medical errors. Since the issuance of the final bar code rule, various entities, including members of Congress and a consortium of hospital groups and manufacturers, have asked that the Agency revisit the issue of bar coding medical devices to improve patient safety; improve quality of care; and encourage cost effectiveness, e.g., of health care by improving delivery and supply chain efficiency.

Areas Covered in the Session:

• Understand how to implement the Unique Device Identification
• Identify the uses and benefits of UDIs
• Understand the challenges, recommendations and proposed conclusions from multiple groups
• Review examples of Device Identification management scenarios reflecting the benefits
• Learn where the use of medical device identification encompasses four current main elements

• All end-users from appropriate departments who desire or require a better understanding and overview of Unique Device Identification and current update.
• QA and Compliance
• Regulatory Affairs and RA Specialists
• Marketing
• Consultants
• Technical Writers and employees who review labeling/tracking info