Today, the healthcare industry crosses another Unique Device Identifier (UDI) milestone: the deadline requiring all implantable, life-supporting and life-sustaining devices to be labeled with a UDI. Two years ago, the U.S. Food and Drug Administration (FDA) issued its UDI Rule. Since then, Global Healthcare Exchange, LLC (GHX) has worked closely with healthcare suppliers to help them navigate the complexities of becoming UDI compliant and to leverage the rule to improve how they manage product data and work with customers.
The FDA UDI Rule requires manufacturers to assign and label their products with UDI-compliant codes and publish data on those products to the GUDID, with a goal to improve patient safety by reducing the incidents of injury and death that can result from the misidentification of medical devices.
To mark the healthcare industry’s impressive progress since implementing the UDI rule, GHX today shared five best practices and lessons learned around UDI compliance:
1. Do Not Underestimate the Technical Challenges
It’s a mistake for an organization to believe the only technical component to complying with the UDI rule is to label products and enter product data into the FDA’s Global UDI Database (GUDID). Suppliers, third-party service providers and even the FDA have encountered unforeseen outages and delays that have impacted compliance efforts. Organizations need to anticipate these technology challenges and create contingency plans to ensure they do not impede compliance requirements.
2. Have a “Single Source of Truth” for Attributes
Nearly all suppliers have encountered challenges identifying and capturing the attributes necessary for GUDID submissions. Most suppliers expect that all data attributes will be in their ERP/PIM systems – only to find during compliance initiatives that multiple systems house information about different attributes. Taking a hard look at the organization’s data, ensuring that it’s clean, consistent and consistently updated, will help prevent this issue.
3. Think Globally
Many U.S.-based companies with international operations have encountered major compliance delays due to misaligned UDI efforts. Often, the U.S. teams independently initiate compliance projects and then have to pause – or completely start over – once foreign counterparts become involved. There are also other UDI-like regulations being created and implemented in various countries throughout the world. Companies need to educate their overseas operations on the urgency and complexity of UDI compliance, while keeping a close eye on the developing international regulations.
4. Ensure Proper UDI Assignment to Products
Some suppliers have realized late in their UDI compliance processes that previously assigned identifiers (e.g., GTINs, HIBCCs) are inconsistent with the packaging levels that need to be documented at the point of use. For example, some identifiers are at the sales unit of measure vs. the true point of use. Situations like this present major challenges if unexpected UDI assignments and labeling changes occur.
5. UDI is Not Just for Manufacturers Anymore
While the UDI rule primarily impacts suppliers, there is a requirement on the horizon that will greatly impact healthcare providers as well. When the final UDI rule was published, the FDA stated it planned to make amendments to some existing regulations to ensure UDI conformity. One of these changes includes Part 803.32, which requires hospitals and other user facilities to include the UDI when reporting adverse events involving serious injury or death. The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) have current proposals under review that would require hospitals to create a list of patients’ implantable devices using the UDIs in EHRs, parse the device identifier and production data from the UDI and link to the GUDID to retrieve device information.
Image credit: Olympus AU5400 AU5432 AU5422
