As Henry Schein evaluated the FDA’s requirements for Unique Device Identification (UDI), Jeff Peacock, VP of Global Quality Assurance and Regulatory Affairs, realized he and his team had a daunting task ahead of them. Henry Schein manages the distribution of approximately 100,000 different medical device SKUs in the United States, with roughly 10,000 of those bearing a Henry Schein label.
Each record in GUDID, the FDA’s UDI database, is made up of 62 data fields. Since Henry Schein acts as distributor for a very large network of device manufacturers, it is ultimately responsible to the FDA as the labeler of products bearing the Henry Schein name.
“There is no other label on the product except ours,” says Peacock, so responsibility for submission to the GUDID rests with his department. “The unique challenge is that the majority of the data are maintained by the OEM manufacturer.”
As the Henry Schein team was faced with collecting, normalizing, submitting and maintaining all of this data for each product in U.S. distribution, they realized the process would be extremely time consuming and at high risk for error. Not only was it necessary to collect hundreds of thousands of data fields, but each manufacturer stored and formatted the data differently. All entries would need to be collected, standardized and checked against company records and FDA business rules. To get started, Henry Schein needed to determine a method for managing and submitting this high volume of data to the FDA.
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