GS1 US has published an implementation guidance, titled “Point-of-Care Scanning for Surgical Implants,” to help healthcare providers electronically capture unique device identifier data for surgical implants at the point-of-care (POC). This can include scanning of medical device product barcodes in the operating room, at the patient’s bedside, or anywhere a healthcare professional is administering care—helping to ensure the right device is used at the right time for the right patient, and that the patient’s record reflects the correct device identification.
The implementation guidance was developed by the GS1 Healthcare US® Point of Care Scanning Workgroup with input from healthcare providers implementing GS1 Standards for POC scanning and solution providers of associated supporting systems, including electronic health records (EHRs), enterprise resource planning (ERP), and device inventory management systems. The Workgroup examined key aspects of POC scanning projects, gathered implementation insights and lessons learned, and identified key considerations to plan an implementation project, such as data readiness (data acquisition/sources, data storage and data flow) and system readiness (hardware and software readiness, and interoperability).
“The ability for hospitals to scan surgical implant UDIs is essential to realizing the full benefits of the U.S. Food and Drug Administration’s Unique Device Identification Rule, said Angela Fernandez, vice president of community engagement, GS1 US. “POC scanning not only saves time and increases accuracy, but it also helps improve patient safety. When accurate data and implant identification is stored in the patients’ electronic health records, providers can facilitate better care.”
GS1 is a U.S. FDA-Accredited Issuing Agency for UDI, and GS1 Standards are authorized for use in implementing the requirements of the U.S. FDA UDI Rule. POC scanning utilizes two types of data: data from a barcode and product master data from supply chain systems. The GS1 Global Trade Item Number (GTIN) is what connects them; it is encoded in the barcode as the unique device identifier (DI), and is stored in supply chain systems as a key for accessing information about that product, making POC scanning accuracy possible.