Medical Device Tracking: UDI Barcode Scanner

How to Get Started with Medical Device Tracking

What exactly is a UDI barcode and how is it used?

UDI barcodes are made up of two parts. A device identifier with the manufacturer and device information, and a __ production identifier with the Manufacture Date, Lot Number, Serial Number and Expiration Date.

Together, they create a unique identified that lets every medical device be tracked and traced. Similar traceability needs exist in other regulated industries, including cannabis production.

Why is tracking medical devices with a UDI barcode scanner important?

Since 2016, recalls of faulty or expired medical devices have risen over 70% (Statista, 2021).

With UDI barcodes, medical professionals can instantly identify which patients received a recalled device, avoiding the invasive surgeries that were once needed to identify them.

Why can tracking UDI barcodes be difficult?

UDI barcodes can be encoded in three different formats, GS1, HIBCC and ICCBBA, each showing the same data differently. Because many systems can’t read every format, manufacturers often add multiple barcodes to products which can cause confusion to care providers who are unsure which to scan and relying on manual data entry, which only increases the risk of errors.

How can I use Orca Scan as a UDI barcode scanner?

The Orca Scan Medical Device Tracking template automatically extracts the Device Identifier, Serial Number, Manufacturer/Production Date, Lot Number and Expiration Date from a UDI barcode. If the device is registered with the US FDA, Orca Scan will also populate the manufacturer’s name and device description - reducing human error.

To get started:

1. Register for an Orca Scan account or sign in to your account
2. Create a new sheet using the Medical Device template
3. Download the Orca Scan app
4. Scan a UDI barcode and enter the quantity if needed, hit save.

To view all your medical devices, including locations, along with a full audit log, just log in to the web application.

How to enrich UDI barcodes with data from another sheet

You can automatically enrich your UDI barcode scans with details like Description, Reference Number, and Supplier Name by linking your sheet to another Orca Scan sheet containing that information:

1. Prepare your master sheet
   • Import a list of all device identifiers
   • Rename the barcode column to Device Identifier – this is the value that will be matched during scanning
2. Allow public access to the data source
   • In the master sheet, open the Integrations tab
   • Enable Allow public URL access and copy the URL key
3. Link your scanning sheet
   • Open the child sheet you’ll use to scan UDI barcodes
   • Go to the Integrations tab and paste the URL key into the Lookup URL field
   • Add the parameter ?extract=$UDI:DI to the end of the URL
4. Match the column names
   • Make sure your child sheet has the same column names as the data source (Master Sheet)(e.g., Description, Reference Number, Supplier Name).
   • The Device Identifier in the scanned barcode must match one in the data source.

Once linked, Orca Scan will check the data source every time you scan a UDI barcode. If a match is found, it will automatically pull across any matching fields into your scanning sheet.