The enterprise information management techniques of data governance, data quality management and master data management for product information should all play key roles in tackling the data challenges of unique device identification compliance. But what is the best way to employ these approaches to get started?
When initiating an EIM program focused on UDI compliance, a good place to begin is with an understanding of your company’s organizational and infrastructure readiness. Leveraging a data governance program or team for this readiness assessment will ensure that business priorities and goals are balanced with the technical requirements of UDI compliance. If you haven’t established a formal data governance organization yet, it is important to pull together a cross-functional working group to drive this effort — this will lay the foundation for a more formal data governance team. It is also essential to enlist a steering committee or group of senior business leaders to provide guidance, feedback, authority and funding to this working group as they develop the roadmap for achieving UDI compliance.
Assess Organizational Readiness
Organizational readiness refers to the understanding of the available people and processes that can be leveraged to implement a given program — in this case, complying with UDI requirements. The primary roles involved include:
- Decision-makers to provide authority and adjudication of conflicts.
- A cross-functional working group to create the strategy and implementation plan, taking into consideration the legal, functional and operational requirements of the initiative.
- Data governance lead(s) to drive the creation of policies, standards, rules and metrics to control and measure the data.
- Data stewards to lead the implementation of governance guidelines within the different business units.
- Data custodians to remediate the data as needed.
- Data quality analysts to report on and measure data quality issues.
- Technologists to fill the gaps in the systems and infrastructure.
Assess Infrastructure Readiness
Assessment of infrastructure readiness will help establish an understanding of the existing systems that create and manage device data and labels. It will also serve to convey the impact to systems and processes of creating a unique identifier and submitting corresponding attribute data for each device to the FDA’s Global Unique Device Identification Database.
During an infrastructure assessment, it is important to ask the following questions:
- Is product data already being mastered within the organization? If so, can that hub be leveraged to handle UDI needs?
- How many different sources of device and packaging data exist, and are they currently integrated into the hub?
- If there isn’t a product data hub, is there another technical solution that can be leveraged to create, manage and submit UDI data?
- What changes will occur if another solution is procured to fill this requirement?
Inventory Existing Device and Attribute Data
While assessing organizational and infrastructure readiness for UDI compliance, it is also important to take inventory of your device data and the associated attributes to understand:
- The location and availability of the required data.
- The quality of data across the different data quality dimensions — completeness, conformity, consistency, accuracy, duplication, integrity and timeliness.
- The data lifecycle from creation to destruction.
- Policies, processes and standards for the data.
Create a Data Governance Roadmap and Change Management Plan
Once you have an understanding of the existing resources available to you, it is easier to create the roadmap and associated change management plan for implementing EIM in support of UDI requirements. This roadmap should involve an incremental approach starting with a subset of your company’s riskiest class of devices to ensure that the plans made, solutions identified and processes proposed can efficiently and effectively address the needs of UDI compliance.
As discussed in the introductory article in this series, the primary goal of the FDA’s unique device identification mandate is to improve patient safety as it relates to medical devices. Only with a universally adopted system that enables standardized, automated identification and tracking of these devices from distribution to end use will we have the ability to achieve this critical goal. But the benefits don’t stop there. A UDI system will be of value to stakeholders throughout the health care value and supply chains, offering numerous efficiencies and cost savings as well as a wealth of useful information.
However, there are big hurdles to overcome. Complying with UDI regulation will require updated or new technology as well as operational and organizational changes. Companies that have started down the path of governing their data and are already proactively improving data quality and standards will find that compliance is an extension of efforts already under way. Organizations that have not yet started (or that have but may be stuck) can find practical guidance in an enterprise information management approach that includes data governance, data quality management and product information management.
For device manufacturers, however, focusing on the data-related changes necessary for UDI compliance alone misses a broader opportunity. Such an initiative must be part of a bigger data governance and management plan to ensure that an organization establishes a foundation to easily respond to any new regulation. Data governance and management must become a strategic priority for organizations. But organizations can leverage UDI planning and implementation both to drive standards within the organization and as a foundational piece to build centralized product data management tools going forward.
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