The Demerger of 1WorldSync & Atrify: How it Impacts FDA GUDID Users
The beginning of July brought several major announcements in the product content and data synchronization market. The joint venture between GS1 Germany and GS1 US effectively ended with the demerger from 1WorldSync, which has evolved as follows:
- Battery Ventures, a tech investment firm, acquired 1WorldSync’s US operations
- GS1 Germany purchased the European operations “1WorldSync GmbH” from 1WorldSync Holdings
- Atrify is the new name for 1WorldSync GmbH, after GS1 Germany’s acquisition
The market can debate its drawbacks, merits and long-term impact on the product data syndication community. For example, many are now reevaluating the single vendor platform approach or best of breed vendor. Others wonder if these announcements mean the dismantling of GDSN. But most concerned are those customers who submit medical device data to the FDA’s GUDID using 1WorldSync. They are left asking, “With 1WorldSync’s separation from Atrify, what happens to 1WorldSync’s GUDID Connection?”
Historically, under the combined 1WorldSync company, medical device labelers used the Item Management (IM) platform to submit their GUDID data. Behind the scenes, IM routed this data to Atrify’s DSE data pool, which in turn converted the data into a HL7/SPL message for submission to the FDA. Due to the de-merger, 1WorldSync will no longer be able to use Atrify’s GUDID Connector. Effective December 2019 customers and medical device suppliers must submit their FDA data via a new connector linking the Item Manager data pool to the GUDID directly. This migration needs to be completed by the deadline of November 29, 2019.
The bottom line: How 1WorldSync sends data to GUDID is changing. Instead of going through Atrify (a GS1 certified data pool using GDSN standards), suppliers must submit via a different route, or build it themselves.
What does this mean for you, as a medical device supplier?
With this change, you can explore the option of building your own GUDID connections or using a direct connection to the GUDID database. What’s the benefit of this approach over using GDSN? Here are some examples:
- Better end-user support due to easier traceability of data flow
- Better agility to comply with UDI changes (i.e. not waiting for GDSN standards to keep up with regulatory requirements)
- Visibility to “all” acknowledgement messages including intermediary messages (ACK1, ACK2, ACK3)
- Lower system validation (SQA) costs by avoiding the need to test and re-validate regulatory submission system because of frequent GDSN upgrades that have no relevance to regulatory master data (historically, 2-3 upgrades per year on GDSN)
- Ability to protect sensitive data including device listing numbers via data masking & encryption
- Ability to better support situations where GDSN requirements do not align with an issuing agency’s standards
Please learn more about the pro & cons of using GDSN versus direct GUDID connections. https://www.innovit.com/2019/07/24/what-is-the-best-path-for-udi-compliance-examining-two-approaches-for-medical-device-suppliers/