Implementing unique identifiers for medical devices in a series of steps between now and 2020 is a daunting task, according to consultancy KPMG. A recent report from the firm walks device manufacturers, providers and other stakeholders through requirements of the final rule published in September 2013 and the technology behind the identifiers, explains the benefits and challenges, examines the parts of organizations that will be affected, and includes a brief glossary of terms.
The UDI is intended to standardize how medical devices are identified in human readable text and machine readable forms such as a bar code or data matrix code. Information on the identifier includes product name and labeler, lot number and expiration date, and serial number and manufacturing date where applicable. An FDA data repository will store information unique to all manufacturers medical devices. Each manufacturer must submit data on more than 60 attributes.
<B>Benefits of UDI</B>
Standardizing identification of medical devices is expected to reduce misuse of devices as well as errors and adverse events, improve the comprehensiveness of recalls and other FDA communications, improve inventory tracking and rotation across supply chains, and ease integrating of device data into EHRs and other information systems.
The list of UDI challenges is daunting. They include IT system upgrades, interpreting rules and determining strategy, emerging market regulations, aggressive compliance timelines, competing priorities, lack of resources and experience in this area, and readiness of others to receive UDI labeled products.
<B>The People Factor</B>
Departments across an organization that UDI will affect include regulatory affairs, quality assurance, supply chain, information technology, graphics/label design, packaging engineering and operations, customer service, brand protection and marketing, commercial trade, sales and operations planning, and master data management.
With UDI, organizations face new questions they havent previously tackled. Who owns the UDI attribute data? Who needs access to the data and why? Who is responsible for updating when regulations are changed? What are the downstream implications? What changes are needed to operating procedures and training?
Achieving effective data governance within the organization requires various business functions accepting that they own the data associated with the products, and are responsible for its accuracy and maintenance, according to KPMG. This includes development and submission of UDI attribute data collected, stored and maintained; collecting/retrieving data attribute information from internal systems; printing and marketing equipment for unique bar codes; camera inspection stations to verify bar codes and labels are printed accurately; automated tools for inspection, conveyor transport/sorting and rejection stations; and direct marking of equipment and technology for implantable and reprocessed devices.
<B>What Does This Mean?</B>
A glossary of terms explains Unique Device Identifier (UDI), Device Identifier (DI), Production Identifier (PI), Global UDI Database (GUDID), Attribute, and Automatic Identification Data Capture (AIDC). The KPMG report is available here.