Q: What is the FDA’s UDI mandate?
A: The FDA issued a final rule on September 24, 2013 establishing a labeling system for the identification of medical devices through distribution and use with a unique device identifier, or UDI.
Q: How will this mandate be carried out?
A: The FDA rule requires that the package of every medical device include a UDI in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology such as a barcode, RFID, etc.
Q: When will this mandate be carried out?
A: The FDA is aiming for an aggressive time table for implementation of the UDI system, with most high-risk medical devices required to carry a UDI on their label within the next year, moderate-risk devices within the next three years, and most low-risk devices within five years.
Q: What is the goal of the UDI system?
A: This system will enable the FDA to address more effectively a growing public health concern about patient injuries and deaths related to medical devices. By ensuring accurate monitoring and swift identification of devices implicated in adverse medical events, UDI will improve product recall management and patient safety.
Q: What is the GUDID?
A: GUDID is the FDA’s new public, searchable Global Unique Device Identification Database (GUDID), which the UDI will be used in conjunction with.
Q: How will this change affect healthcare providers?
A: We anticipate that healthcare providers will benefit greatly from using UDI on their devices because it will help them improve their clinical inventory management and enhance their tracking capabilities (expiration, consignment, etc). Using UDI will help provide hospitals with more accurate and efficient inventory data, the ability to implement better management tools, improved accuracy of invoices, and a reduction in the number of erroneous purchase orders.
The UDI will also be valuable for accurate clinical documentation – systematically documenting medical devices throughout the supply chain all the way to patient records.
Q: Is the FDA requiring the use of a specific type of AIDC technology?
A: No; however, the most commonly and widely accepted form of AIDC technology is the barcode. There are currently multiple different classes of barcodes being printed on medical devices and supplies. VueTrack™ is an advanced barcode scanning technology system that is uniquely suited for reading, parsing and interpreting over 120 classes of barcodes, and for accurately and swiftly extracting the product ID, lot/serial number and expiration date. It will become vital, when embracing the UDI system, to consider upgrading at the same time to a system like VueTrack™ that can handle any barcoded information and provide a seamless feed into clinical documentation as well as materials management systems.
Q: What is new with VUEMED?
A: VUEMED has under development two new tools in beta version that leverage its unique expertise and technology applied to inventory management and clinical documentation through barcodes. The first one, VueScan™, is specifically designed to assist with the documentation process of medical devices and supplies at the point of care by allowing it to identify and parse all barcodes, and pass in real time the right information in the right data input field of the clinical documentation system, thus providing accuracy with expediency in one step. The other tool, VuePar™, is designed as an audit tool primarily for the materials management function, whose main objective is to allow actual SKU quantities available on the shelves to be periodically checked against active par levels to determine necessary reorder numbers. VuePar™ accommodates management at the SKU level but also handles the Kanban system or a combination of both, as well as consigned and non-consigned inventory.