Two Main UDI Compliance Problems and Why They Matter

What is UDI anyway?

In 2013 the FDA created the Unique Device Identification system for identifying medical devices sold in the U.S. This standard encoding system enables track & trace from point of origin in the manufacturer’s facility to point-of-use in a patient procedure. This FDA rule requires medical device labels to include a unique device identifier (UDI), and the device’s information must also be submitted to the FDA’s Global UDI Database (GUDID). GUDID is a publicly searchable database meant to be a transparent and comprehensive source of information for patients, healthcare professionals, and regulators. A key motivator for this rule was to provide rapid identification of medical devices with adverse events.

What are the main benefits of accurate UDI data – why is it important?

Patient Safety – It enables providers to quickly track recalled items to individual patients. This is possible because the UDI data is part of the procedure record and allows for accurate and efficient correlation with manufacturers’ recall announcements.

Inventory Management – It ensures that essential devices are always available, but can also reduce waste and overstocking by having an accurate snapshot of what’s on the shelves. UDI, when referenced between vendors and supply chain, acts as the primary identifier for medical devices.

Tracking Patient Outcomes – It gives providers data insights and new perspectives that are important for improving procedural outcomes and identifying areas for product improvement. UDI allows for medical data to be transmitted – free of private patient data–between facilities for advanced analytics and drawing of associations between products.

Two main UDI compliance problems – real world implications

  1. Misprinted barcodes:
    A barcode misprint on a product package means either that the UDI was improperly encoded in the product barcode or the incorrect UDI was printed on the product packaging. This can cause incorrect data to be captured or prevent a barcode from being scanned at all. Capturing the wrong data can lead to an inaccurate accounting of inventory levels and reordering quantities. Interruptions in patient care can occur, for example, if a device is needed for a procedure but is not in stock due to improper UDI capture. Barcode misprints slow down the workflow and make expiration and recall management more time-consuming and less accurate. They can also cause different products to be documented in inventory or at the point of care.
  2. Multiple device identifiers for one product
    This is an issue that can occur if the same device is submitted multiple times or if the device ownership changes hands and is submitted as a different product while the original is still in commercial distribution. In theory, a product should never have multiple primary DIs, but this issue still occurs due to a lack of validation or unintended uses of UDI. This can cause disruption in communication between the supplier and hospitals, which are expecting accurate one-to-one matching based on the UDI. Also, this problem means that providers are unable to align their supply chain item masters with the GUDID database due to multiple positive matches. And clinical billing and reordering systems will not trigger due to item data being associated with a different UDI.

How can the industry improve UDI compliance?

The FDA offers a submission form for voluntary reporting of UDI compliance issues.  Manufacturers should understand that the intended use of UDI is for the entire healthcare system to have a single source of truth for product data. They should also understand that compliance with that system improves overall efficiency as well as patient outcomes, and can provide valuable purchasing and utilization insights based on the capture of accurate UDI data.

Providers and manufacturers should also take advantage of additional industry resources to bring awareness and discuss solutions to address UDI compliance issues. These include the provider-focused AHRMM UDI Forum and industry standards associations such as AIM Global and GS1.

FYI: On June 5, 2024, Lana Makhanik, VUEMED’s COO, will be co-presenting at GS1 Connect with Christina Crowe, VP of Supply Chain at Westchester Medical Center (WMC). They will present “The Untapped Value of Accurate Item Master Data in Hospitals,” and will discuss how WMC ensured revenue integrity and supply chain efficiency using proper, comprehensive, and accurate item master data. Stay tuned, as well, for VUEMED’s participation in an AIM Global webinar and podcast on the issue of UDI compliance (dates forthcoming).