the new ruling on UDI

I would like to share with you some of my initial thoughts regarding the recent FDA’s ruling on Universal Device Identification (UDI) and where companies may fall short in their plans. There are several packaging and labeling requirements in this ruling and any organization’s plans must include these new requirements. A small portion of this ruling, but with a large long term impact, is the management of product data and its communication to the FDA.

The FDA plans on making this data available for public and hospital information systems. The idea that organizations already control all of the information related to its product is not entirely accurate. Not all of the information is in clear and consolidated formats. As I sat through a planning session at another organization, the conversation was about how we would get the product information and who needed to be the owners or providers of this information.

the problem and solution

The problem was that we didn’t know at that time what information was needed. The question needed to be “what is the process for managing the information?” Not everyone in the organization can send or update data to the FDA’s Global Unique Device Identification Database (GUDID). The product information needed to be gathered from several different area’s and we had no real method of controlling content or how much information to capture.

The solution was to designate a data steward. Consolidating the data to a single source and process is practical and helps mitigate errors. This is not a new department or new function that is added to a department. This is an extension of an already established process in GMP organizations. It’s called Document Control or Configuration Management. People in this role have a particular ability to analyze a change and information impacted from the change. In their current roles they take data from multiple functions and translate it into usable information in other systems. In its basic form, configuration management data is transformed from specifications, drawings and Bills of Materials for Enterprise Resource Planning (ERP) and manufacturing systems.

With a Product Lifecycle Management (PLM) process, an Analysts must manage and interact with the data owners to update the GUDID for their organization. The cost of this additional data process will be determined by how easy and quickly this group can manage the information. So, how does this system affect people that are using Oracle Agile PLM? Managing the UDI adds a layer of interchangeability to configuration management review of changes and new product development.

PLM making it easy to manage data

Agile PLM is a perfect place to manage the data that is part of the UDI. The UDI is a number or a part object that can easily be controlled as a part subclass along with the Product Information attributes that are required for the GUDID. And a product like ZWS’s GTIN Generator can automatically build a UDI from your product data. Product Lot data for the GUID can then be linked to this information and available for the GUID.

Looking to the future, if the FDA changes data requirements, Agile can easily add a field to accommodate that
change. Permissions and data characteristics can be set for each type of required data. Bulk exports and updates can be made to the GUDID with a simple export on a regular basis.

Using a part object, the configuration structure allows the UDI object to be the parent of a model number or manufacturing configuration. The GUDID is also now part of the Device Master Record (DMR) and Device History Record (DHR). Even though for class III medical devices will require the UDI marked on the device, the parent/child structure sill makes the UDI as the highest level of information, not subordinate to the manufactured structure. Configuration Management must also think long term with this data. It is the FDA’s intention to use the UDI in hospital systems and customer related information.

Complaints and other issue management systems, i.e. lot numbers must be able to trace back to the specific UDI number. This will be difficult if the manufactured or inventory number doesn’t maintain traceability and have interchangeability to the UDI. I guarantee that organizations will want to make revision changes to product and not change the UDI.

As foreign of a concept as this might seem, GS1/UPC and other UDI compliant structures allow for these types of changes. The key will be to develop interchangeability rules that are clean but allow flexibility and do not over burden the organization.

[Edit: Repost from 2014]