UDI adoption: It takes a community

Healthcare is a complex system, made up of many different disciplines and organizations, usually focusing on their individual pieces of the puzzle. Members of many of those different sectors came together in late June for the first official meeting of the Learning UDI Community (LUC).

The LUC is being hosted by the Association for Healthcare Resource & Materials Management (AHRMM) with active participation by the Senior Advisor for UDI Adoption, Terrie Reed, with the Food and Drug Administration (FDA). The purpose of the LUC is to advance the value of unique device identifiers (UDIs) for medical devices, as mandated by the FDA’s UDI rule, across healthcare. That rule requires manufacturers to assign and label their medical devices with a UDI and provide additional information on those products to the FDA’s Global UDI Database (GUDID). The LUC will accomplish this by identifying issues that impact UDI adoption in the healthcare setting and establishing cross-industry work groups made up of subject matter experts and stakeholders. Work groups will publish their findings in a repository housed by AHRMM and open to anyone who is interested. The work groups may also develop resources that focus on the topics (e.g., use cases) and enabling technologies that can accelerate UDI adoption.

As the supply chain organization for the American Hospital Association, AHRMM recognized the need for such a community and the role it could play because supply chain interacts with many of the disciplines and organizations touched by UDI, including physicians, financial leaders, value analysis and central sterile processing in healthcare systems, as well as manufacturers, distributors, group purchasing organizations, technology companies and clinical researchers. The LUC community also includes representation from patient advocacy groups, standards bodies, and regulatory agencies. The LUC is also recruiting members at large who are interested in participating in various work groups.

The LUC has no shortage of potential topics to pursue and has already begun creating workgroups for several of those issues:

• What are the best practices and technologies for validating and scanning UDIs in the healthcare environment (e.g., barcodes, RFID, etc.)?
• How and why should manufacturers populate clinically relevant size fields in the GUDID? How will various stakeholders use those fields?
• What standards should be developed or used to delineate unit of measure in the GUDID to ensure consistency in EHRs and other systems?
• How can we define, use and generate value from a “virtual” Unit of Use device identifier in the GUDID for products with a base package containing more than one item and those items are not individually marked with the UDI?
• Other issues under consideration include:
• How should you track the history of a medical device as its manufacturer goes through mergers, acquisitions and divestitures?
• What device type code (e.g., SNOMED CT) will be used by electronic health records (EHRs) to describe implantable devices in the now-mandated device list contained in a patient’s medical record?
• Is the Global Medical Device Nomenclature (GMDN) term, commonly used by regulators, of value in the healthcare delivery setting?

Many of these topics stem from the need for manufacturers to comply with the UDI regulation with their customers in mind, something not everyone is doing yet as judged by how some manufacturers are populating the GUDID. For example, some have used information associated with their 510(K) regulatory approval information as the content for the product description field in the GUDID. 510K descriptions are used to demonstrate to the FDA that a device not yet on the market is as safe and effective as those that are already for sale in the U.S. Unfortunately, those descriptions are rarely structured in a manner that is of value to clinicians and others who rely on device descriptions when sourcing and using products in patient care.

At a meeting discussing the LUC at the GHX Healthcare Supply Chain Summit, Reed recalled a cross-functional industry discussion when a manufacturer suddenly realized he was speaking with a clinical researcher who was using the information his company had populated in the GUDID. He had not previously considered that the data would be used by anyone other than the FDA. That’s not a condemnation of the manufacturer but rather just an example of what happens when we are heads down in our respective silos, doing everything we can to meet expanding regulatory requirements and forget that we are operating in a system where we are dependent upon the other sectors and the information they generate.

To me, the real value of UDI will be realized when we call the same device the same thing regardless of what we are doing with the device (e.g., sourcing it, buying it, storing it, using it, evaluating its performance). This common language and transparency is increasingly important as we move to a value-based healthcare system, where everything we do, including the use of medical devices, needs to be viewed in regard to the impact on multiple, interdependent factors: cost, quality, patient satisfaction, reimbursement, etc. Healthcare reform is forcing us out of our silos, and a common language for medical devices, from the identifiers to the attributes associated with those identifiers, will be key.

Many of the topics for the UDI community will be generated by the steering committee as well as questions coming in to the FDA’s UDI Help Desk. Ideas can also come from those who read or share this article with colleagues. Do you have an idea for a topic for the LUC? Would you like to serve as a member at large within the LUC? If so, I would like to hear from you. Send a note to me at [email protected] or to Mike Schiller with AHRMM at[email protected].