5 Things to Consider When Defining Your UDI Strategy
The FDA has passed legislation requiring all medical devices to have a unique device identification (UDI) number to make them recognizable and traceable across the entire medical field. By 2020, all medical devices must have labels containing the UDI, which is readable by both humans and machines. The information about each device then has to be submitted to the FDA’s Global Unique Device Identification Database (GUDID).
Therefore, if you are in the medical field, you are going to need to make some adjustments to be compliant with these new regulations.
Defining a UDI Strategy
Before you can outline a UDI strategy, you must understand your business’ current product data structure and identify gaps in your current processes; you should also focus on the cleanliness, totality, and standardization of your product’s master data. Only after you’ve accomplished these tasks can you map a new environment specific to the UDI requirements.
The first step is choosing a system to record your product’s UDI data. The system serves as a hub for all product data and will share master UDI data with external systems, including the FDA GUDID and the GS1/GDSN data pools.
What to Ask Yourself
Consider these questions as you analyze your current product data management system and consider your UDI implementation strategy:
- Are you planning to source data submissions to the GUDID from a single system or will you multi-source and aggregate the data from several existing systems?
- Does your current system serve as your strategic “go-forward” solution for gathering, housing, and distributing product data?
- Is your data set small enough to manage data cleansing/normalization manually or will you need an enterprise resource planning solution to produce quality output?
- Is your planned solution built on open technology that can support data imports from and data exports to other systems?
- Does your solution include tools and workflows to manage product approvals and integration processes?
The FDA offers 3 methods to update the GUDID, including:
- Manual entry via the FDA web portal
- Entry through the GS1 GDSN data pool
- Bulk XML HL7 SPL web service submission
Answering those questions and considering those methods will drive any strategic decisions you make regarding a data management system and your overall UDI implementation strategy, with the end goal being UDI compliance.
For more information about implementing a UDI system, contact us today.