The Barcode Dilemma

With thousands of lifesaving medical devices at hospitals, managing inventory is a critical—but often a manual—process. Now, with the U.S. Food and Drug Administration's (U.S. FDA's) Unique Device Identification (UDI) Rule, almost every medical device sold for use in the U.S. now has a barcode carrying the product’s unique identifier and other important production information. By scanning this barcode, clinicians and other professionals in healthcare settings can easily and quickly capture and store critical information they can use to improve inventory management processes and:

Enable more-accurate and efficient recall management and advanced analytics related to cost and patient outcomes.

Allow clinicians to interface with both the electronic medical record (EMR) and an individual’s electronic health record (EHR), with detailed record keeping for more-accurate documentation.

Optimize overall supply chain processes through increased identification and transactional efficiencies.

While lots of information about products is available for use, many healthcare systems are missing out on improving their operational efficiencies because they are struggling to scan and capture this critical data encoded in barcodes.

Comments such as “the barcode won’t scan” and “there are too many barcodes on the pack, and we don’t know which one to scan” have been voiced from hospitals as points of confusion.

But are the barcodes really the problem? In collaboration with a large self-distributed network of hospitals, a barcode scanning exercise was conducted to assess the state of barcodes on products in a hospital.

In total, 12,464 barcodes were scanned, covering the health system’s cardiac catheterization lab, interventional radiology laboratory, operating rooms, laboratory refrigerators, and warehouse—amounting to a total of 6,284 unique products or packaging levels.

Key Takeaways

12k+

Barcodes scanned amounting to a total of 6,284 unique products or packaging levels>

50%

Products or packages scanned having a “single barcode”

75%

Barcodes scanned were GS1 Barcodes

Approach to Barcode Scanning Exercise

Scan areas included the bulk warehouse/fulfillment center, the Operating Room inventory area, the Cardiac Catheterization Lab inventory area, and the Angiography Lab inventory area.

Three teams of two, one GS1 US and one with participants from the hospital, scanned every barcode on every available package level of products in the location.

Handheld scanners differed in model number and age (one was much newer compared to the other two)

Scanners were programmed to recognize any barcode symbology.

Data was captured in a Microsoft Access database, and the package level was identified as “Case,” “Inner pack,” or “Each,” as consistently as possible

Insights From Inventory

Looking at inventory in a real-life hospital setting offered a glimpse into the challenges facing barcode scanning and what opportunities could enhance adoption of this practice.

Challenges for Consuming the Unique Device Identifier With Multiple Barcodes

During the scanning exercise, 18 different barcode types were encountered. In total, the GS1-128 barcode was the most common, with the two-dimensional (2D) GS1 DataMatrix following as the second most common.

Other 1442, Code 128 1567, GS1 DataMatrix 2351, GS1-128 4632

These two were also the most common barcodes to have a Global Trade Item Number® (GTIN®) encoded. The GTIN is a unique identifier in the GS1 System of Standards that can be used to create the Device Identifier (DI), while GS1 Application Identifiers (AIs) can be used to create the Product Identifier (PI). Combined, the DI and PI create the Unique Device Identifier required for the U.S. FDA UDI Rule. Of the 6,284 unique products scanned, all but 61 used the GS1 GTIN as the device identifier.

The Unique Device Identifier is the critical information that hospitals need to capture to unlock visibility into their inventory and improve operational efficiencies—but issues found during this exercise can prevent hospitals from achieving this through efficient scanning.

Clinicians and other healthcare professionals need to determine—in a matter of seconds—which barcode has the Unique Device Identifier information in it. When a product’s package has multiple barcodes that each hold different information or unrecognized barcode formats, this leads to confusion, read failures, and inefficiencies for clinicians.

Also, if a barcode is added to a product or packaging level, but the Unique Device Identifier data is not encoded properly, clinical and other healthcare professionals could receive error messages when scanning. Improper encoding can be caused by data strings not conforming to GS1 Standards or trying to encode GS1 syntaxes into non-GS1 barcodes. During this barcode scanning exercise, we found several instances of improperly encoded data, including encoded parentheses in a GS1-128 or GS1 DataMatrix and encoding of GS1 GTINs in non-GS1 symbologies.

Opportunities to Better Leverage Unique Device Identifier With Consolidation

To enable hospitals to seamlessly capture the critical information they should capture and record, the ideal state is to only have a “single barcode,” with the Unique Device Identifier, on a package. A “single barcode” could mean:

“Physical” Single Barcode  
One physical barcode found on product or packaging level

“Technical” Single Barcode  
Multiple barcodes found on product or packaging level with the same unique device identifier information encoded in each

A “single barcode” was found to exist on 50% of the unique products or packages scanned. About 37% of these were “physical” single barcodes and occurred most often at the “Each” package level.

For those products with more than one barcode, the range of barcode types on a single package was significant. The most common combination of different barcodes on packs was GS1-128 and GS1 DataMatrix paired together. The second most common combination was GS1-128 and Code-128 paired together. Many times, these additional barcodes were not encoded with data relevant to clinicians.

While more than one barcode may be necessary for a variety of reasons, there is opportunity to reduce the number of barcodes relevant for clinicians on medical devices. Of the unique products or packages encountered, 11.8% had at least two different barcode types with the same Unique Device Identifier information encoded on the label. The most common combinations were a GS1-128 barcode coupled with a GS1 DataMatrix and an EAN/UPC coupled with a GS1 DataMatrix.

Another opportunity lies in the data carrier choice. Of the barcodes scanned 14.7% were GS1-128 stacked linear barcodes, which requires two scans to retrieve the supply chain and clinically relevant information for the Unique Device Identifier and the production information. If these were transitioned to a single GS1-128 or a GS1 DataMatrix, the data could be captured in a single scan. Removing redundant barcodes and utilizing a single data carrier that encodes all relevant data could improve barcode scanning in hospitals.

What Can Industry Do?

While multiple barcodes are appearing on medical device products and packaging levels, both hospitals and manufacturers can support the improvement of barcode scanning to help unlock inventory insights.

Hospitals: Focus on Education, Awareness, and Interoperability

To help implement or improve barcode scanning, hospitals should consider improved awareness around barcode types and scanning. This should include how to use barcode scanners and how to visually identify barcodes and packaging information, to help clinicians feel more confident and efficient in performing the scan. Similar education at product touch points prior to patient care, such as scanning at the point-of-receiving or scanning into par locations, can help identify and resolve barcode errors before they get to the clinical area. Equally important is supporting awareness of non-performing barcodes for medical device manufacturers and addressing interoperability gaps with solution partners.

Develop standard operating procedures (SOPs) to address resolving issues when an error is received from a barcode scan.

Educate clinicians, nurses, and other point-of-care staff on barcode basics, including recognizing different barcodes and scanning best practices.

Address interoperability gaps by working with solution providers to ensure systems are set up properly to scan barcodes.

Manufacturers: Continue to Evolve Labeling

There is also room for opportunity and improvements on the manufacturing side. Manufacturers should consider limiting the number of barcodes on a product or package that are not encoded with the Unique Device Identifier. Transitioning to just one barcode type that can hold a wealth of information such as UDI and other necessary data—like the 2D GS1 DataMatrix—will further reduce confusion for customers and free up valuable space on the label. When a single barcode is simply not possible, consider using the ISO UDI symbol to aid visual identification.

Identify opportunities to consolidate barcodes appearing on labels.

Include the ISO symbol for UDI to help customers visually identify which barcode to scan.

Perform recurring barcode validation and verification to reduce the number of failed scans.

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