To improve adverse event reporting, better identify and track counterfeit products and ultimately improve patient safety and care, the FDA Amendments Act of 2007 (FDAAA) mandated the creation of the unique device identifier (UDI) system. This system is intended to assign a unique identifier to medical devices distributed within the United States. Under FDAAA, UDI compliance will require:
- The label of a device to bear a unique identifier, unless an alternative location is specified by the FDA or unless an exception is made for a particular device or group of devices
- The unique identifier to be able to identify the device through distribution and use
- The unique identifier to include the lot or serial number if specified by FDA
All manufacturers of medical devices will be required to comply with the new UDI methodology. And although this law applies to all medical devices, the requirement prioritizes those devices that are implantable or life sustaining as the first products needing the UDI.
In the most basic format, the UDI would be a coded number registered with standards organizations, and it would incorporate a variety of information, including (but not limited to):
- Manufacturer of the device
- Make and model of the device
- Expiry date of the device
- Any special attributes that the device may possess
As the FDA is developing the IT infrastructure necessary to support the effort, including the creation of a searchable UDI database that will serve as the authoritative source for all UDIs and UDI-related information, each manufacturer has one year to comply with the requirements, starting with manufacturers of high priority devices.
Enterprise Data Management for UDI Compliance
One of the biggest challenges for organizations, manufacturers and facilities that are required to comply with the UDI mandate is the need to gather the data elements together, exchange data and manage data as it changes over time.
To overcome these challenges, organizations can employ an enterprise data management strategy. Enterprise data management (EDM) ensures that the data that underlies an organization is available, accurate, complete and secure. It further ensures that architectures, policies, practices and procedures that manage the full data lifecycle are developed and executed.
Employing an EDM program guarantees that product data for UDI compliance is managed and governed based on having the right stakeholders, technology and data processes required to exchange information with the FDA and trading partners. It also guarantees that there is control over the structure, processing, delivery and usage of information. And, it ensures that stakeholders and trading partners can trust the data.
The diagram below shows the overarching enterprise data management framework. Within the EDM framework, master data management for product data, data quality and data governance are necessary to prepare for UDI compliance. They ensure that the UDI data used to identify the device is complete, accurate and consistent and that it both conforms to standards and is properly consumed by other systems.
Source: First San Francisco Partners
So, how exactly does master data management help medical device manufacturers comply with UDI regulation?
Master Data Management for UDI Compliance
Master data management for product data is referred to as a product data hub, or a product information management (PIM) solution. A PIM solution enables centralization of all product information from various systems, creating a single view of product data that can be leveraged across all lines of business and distribution channels. Having a centralized place to manage and govern data ensures that your organization can manage continually changing data.
Having a product data hub is important to UDI compliance because it provides a central place to rationalize and store product data in order to assign a truly unique identifier. Many medical device companies have grown through acquisition and, as a result, employ a plethora of systems to create and manage product data. Each of these acquired entities may also have different labeling processes and standards. Consequently, it becomes difficult to ensure that product codes, item numbers and label identifiers are truly unique and accurate. A product data hub creates an opportunity to clean, rationalize and store product data outside of the lines of business or manufacturing-centric systems, enabling a standard way of creating a unique identifier as well as managing the necessary attributes of each product that will be requested by the FDA. Essentially, by “abstracting” the product data necessary to comply with UDI requirements into another system, it dissociates the creation and management of the UDI from the complexities of the underlying systems.
More than being just a repository for product data and UDI records however, a PIM solution helps to automate the business processes necessary to create, track and manage the coded numbers and labeling information required for compliance. By leveraging the workflow capabilities of PIM solutions, organizations can ensure proper approval processes are followed and an audit trail exists to demonstrate traceability and transparency to regulators. Employing a PIM solution also reduces the manual burden of data management and human intervention which then increases efficiency and productivity associated with UDI compliance.
Ensure that your organization not only has the capabilities to create and manage the required product information to comply with UDI legislation, but that it also takes advantage of product information management technology to do so efficiently. In this way, you will also create a foundation of accurate, accessible product data that can be leveraged to improve reporting and revenue generation efforts as well.