Making UDI work: Get behind the bar(codes)

Aug. 23, 2019

If you want to make unique device identifiers (UDIs) work in your organization, you have to get behind the bar(codes).

Barcode scanning must play a starring role in your quest to improve patient safety and gain better visibility into product usage, efficacy and the impact on the cost and quality of care. Scanning barcodes may not be a new technique or represent new technology, but the adoption in healthcare to date has been slow.

Fortunately, barcode scanning is back in the limelight, following the 2013 publication of the Food and Drug Administration’s UDI rule, which requires manufacturers to assign and label their products with unique device identifiers (UDIs) in both a human and machine-readable (i. e. , scannable) format. UDIs are made up of two components: the device identifier (DI), such as a GS1 Global Trade Item Number, a HIBCC LIC code or an ICCBBA ISBT 128, and a production identifier (PI), which includes information such as lot, serial number, and expiration date. One of the primary benefits of the regulation is to more accurately identify and track recalled devices and device-related adverse events. But realization of this value depends on the ability of hospitals and other healthcare providers to capture and use the UDIs.

The AHRMM Learning UDI Community recently published a report based on the work of the UDI Barcode Scanning at the Point of Care. You can access the report, free of charge, on the AHRMM LUC website (www.ahrmm.org/luc). I have also included the highlights of the report below.

Barcode scanning at the point-of-care

Capturing data on products used in patient care is important for healthcare providers, payors, manufacturers, regulators, patients and others as they seek to understand the role of products in improving quality and lowering the cost of healthcare. Barcode scanning is far more accurate than manual data entry. Errors in clinical supply documentation can have a wide range of negative downstream impacts on processes including inventory management, charge capture and ensuring a complete record of which supplies were used in patient care for cost accounting, recall management, and adverse event reporting.

The LUC workgroup conducted a survey to better identify the challenges associated with barcode scanning in light of the increasing number of UDIs available on product packaging. More than 400 individuals from hospitals ranging in size from less than 100 to more than 1000 beds responded to the survey. Below are some of the key findings.

It starts with scanning

The first hurdle identified is that only half of providers are scanning UDIs at the point of care or capturing UDIs in electronic health records (EHRs). That despite the fact that electronic health record vendors and providers are subject to federal regulations related to capturing, storing and sharing UDIs for implantable devices in EHRs1.

Scanning challenges

Providers that are attempting to scan and capture UDIs in barcodes cite a number of other challenges. Fifty-two percent of respondents said having multiple barcodes on product packages makes it difficult to know which barcode to scan, while 48 percent said unreadable barcodes are preventing successful captures.

When nurses do not know which barcode to scan, or when they must scan two different linear barcodes to get both the device identifier (DI) and the production identifier (PI), they may revert to manual data entry or potentially scan the wrong barcode or none at all.

Recommended Solutions

Survey respondents offered a couple of suggestions to overcome these issues.

• Eighty-six percent said a UDI icon or the word “UDI” next to the barcode would make it easier to identify which to scan.

• Ninety percent said they would support the 2D Data Matrix barcode, which contains the full UDI, as the barcode standard, but only 52 percent said their scanners could read this format.

The report also captured some of the challenges faced by manufacturers when considering the regulations. For example, any change to product packaging and labeling can be a significant and expensive effort, requiring coordination among many internal stakeholders, including those responsible for label and internal leaflet design, printing and packaging, and regulatory compliance. This can take years to implement.

As for unreadable barcodes, 64 percent of providers said they do not know how to contact manufacturers with barcode or data issues. The report recommends manufacturers create a continually monitored email address or call center that can respond effectively to provider questions and needs.

Providers, too, have a role to play: to help educate manufacturers, software vendors, as well as their own internal teams, on the value of UDI, and to make plans to incorporate the unique identifiers across all systems that utilize product data, from procurement and contracting to clinical documentation.

Unique device identifiers have the potential to improve many systems and processes across healthcare. It begins with a better understanding of what is being purchased, in what quantity, by whom, and at what price. The real value comes from improved visibility into what products are being used on which patients, in what settings, for what purposes, by which clinicians, and to what outcomes — both financial and clinical. In this way, we lay the foundation for the delivery of real value in healthcare: for the manufacturers who create and sell the products, for the hospitals and providers who procure and use the products, and most importantly for patients who depend on a system that has visibility into what can deliver quality care at an affordable price. hpn

References

1   www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/2019ProgramRequirementsMedicare.html

Karen Conway, Vice President, Healthcare Value, GHX, works to advance the role of the supply chain as a critical enabler in the pursuit of a value-based healthcare system.

About the Author

Karen Conway | CEO, Value Works

Karen Conway applies her knowledge of supply chain operations and systems thinking to align data and processes to improve health outcomes and the performance of organizations upon which an effective healthcare system depends.  After retiring in 2024 from GHX, where she served as Vice President of Healthcare Value, Conway established ValueWorks to advance the role of supply chain to achieve a value-based healthcare system that optimizes the cost and quality of care, while improving both equity and sustainability in care delivery. Conway is former national chair of AHRMM, the supply chain association for the American Hospital Association, and an honorary member of the Health Care Supplies Association in the UK.