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Guidance for Point-of-Care Scanning for Surgical Implants

New Resource Offers Best Practices for Capturing Data to Support FDA’s UDI Rule

An implementation guidance, Point-of-Care Scanning for Surgical Implants, has been published to help health care providers capture unique device identifier (UDI) data for surgical implants at the point-of-care (POC). Medical device barcodes can be scanned at a patient’s bedside or in the operating room, for example, helping to ensure the correct device is being used at the right time for the right patient, and that the patient’s record includes the correct device identification.

Hospitals’ ability to scan surgical implant UDIs is important, not only in terms of the U.S. Food and Drug Administration's Unique Device Identification Rule. POC scanning saves time, increases accuracy, and improves patient safety. Accurate data and device identification in patients’ electronic health records enables providers to administer better care.

POC scanning uses two sets of data: one from a barcode and master data from supply chain systems, and a GS1 global trade item number® (GTIN®) connects the two. The GTIN is encoded in the barcode as the UDI, and stored in supply chain systems as a key to access product information, ensuring scanning accuracy. 

The implementation guidance was developed by GS1 US. 

Source: GS1 US, January 31, 2019

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