Providing UDI data to Hospitals & GPOs Part 1
A Medical Device Supplier’s Perspective on the Journey (Part 1)
As with most medical device companies, our journey into the world of UDI began with the introduction of new US FDA requirements to publish product data to FDA’s UDI database called GUDID (Global Unique Device Identification Database). Each product must be assigned a unique number for identification purposes, such as codes from GS1 (GTIN); HIBCC (HBIC) or ICCBBA (ISBT).
In the beginning, there were many unknowns. For example, how to submit our product data to the FDA was a mystery at first. Some companies were caught up in the idea that they only had to worry about the FDA and as such designed a solution around that one set of data requirements. However, as more and more details emerged, it became necessary to develop a scalable strategy to submit information not only to the FDA but also to other regulators and possibly to customers.
An analysis of the global environment showed from the outset that the number of endpoints on which our data would have to be published would increase exponentially over the next few years. The new regulations emerging from different countries and the growing demand from customers for product master data made it clear that the solution had to be scalable without us having to develop a new connector for every scenario. Interfaces and connectors are the bane of any IT organization’s existence.
“An analysis of the global environment showed from the outset that the number of endpoints on which our data would have to be published would increase exponentially over the next few years.”
Minimizing maintenance for all these connectors was crucial to avoid problems and escalating costs. In addition, the solution had to be scalable with the increasing volume of UDI data submissions, and the number of data attributes required. Our strategy from the outset was to use the Global Data Synchronization Network (GDSN), data pools, and commercial solutions to provide connectivity to all endpoints. We were able to leverage a GDSN-certified data pool to gain some economies of scale and to make tasks easier, but we also needed a PIM system that was designed for regulatory compliance in the Life Science industry – including compliance with 21 CFR Part 11 and GAMP5 system validation.
As a company, we didn’t do business with Group Purchasing Organizations (GPOs). Our strategy was to have a direct relationship with the customer. However, with UDI data, that changed.
Shortly after the FDA published the deadline for submitting UDI product information for Class II devices, I received an email from one of our sales representatives asking for help in submitting UDI data to one of our clients, a healthcare network consisting of several hospitals, medical centers, clinics, and a university health center.