RFID tags can be a powerful tool for improving healthcare supply chain management with real-time visibility and streamlined inventory management.
By Andrew Meyer, Director, Global Standards, GS1 US
Healthcare product manufacturers grapple with supply chain challenges, inventory management issues, and traceability requirements to support patient safety, including adherence to the US Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) regulation. As the industry seeks new solutions to better serve a digital, heavily regulated, global marketplace, new and enhanced technologies are considered essential to fortify the supply chain with advanced track-and-traceability and inventory management strategies.
Hospitals in the US had a very hard time obtaining desperately-needed ventilators during the height of the COVID-19 pandemic. The shortage was driven by unanticipated demand that overwhelmed healthcare systems, and it was exacerbated by a lack of supply chain visibility. Many hospitals faced the frustrating challenge of trying to locate ventilators that were stored in various facilities, often in different regions. Outdated inventory management systems and a lack of standardized tracking protocols hindered efficient allocation. This is a perfect example of why track-and-traceability is crucial for healthcare products, even beyond regulatory mandates. Precious time gets lost when the necessary medical supplies cannot be found and deployed promptly for patient care.
Products can only be tracked when they are first uniquely identified. The UDI Rule specifies a mandatory identification scheme for this purpose. It includes a unique device identifier (UDI) represented by a GS1 Global Trade Item Number (GTIN), and a production identifier (PI) which may include a lot or batch number, serial number, and date of expiration or of manufacture. Regulated medical devices must be labeled with these UDI data elements in both human readable and a machine-readable form that uses automatic identification and data capture (AIDC) technology – such as a barcode – for scanning throughout the supply chain to record the product’s movement from point of manufacture to point of use.
New two-dimensional (2D) barcodes are now being used in many industries, including in healthcare and especially pharma, to add substantial functionality. These 2D barcodes (like the GS1 Data Matrix or a QR code) can be encoded with considerably more data than a linear barcode. This creates an opportunity to convey expanded product information that can be accessed with a smartphone scan. Since the 2D barcode has virtually unlimited data capacity it can be used to host instructions, warranties, manufacturing details, serial numbers, and additional clinical and patient information. All you need is an optical scanner, which today is already on most smartphones and devices.
Streamlining Inventory Management
Radio-frequency identification (RFID) is another technology that can be used to help build efficiency into the inventory management and track/trace procedures for healthcare products. While barcodes provide end-to-end product identification, RAIN RFID, which specifies use of the UHF frequency band and leverages the GS1 air interface protocol to communicate with tags, serves a separate and distinct purpose. It is used in conjunction with the barcode as a secondary identification system with specialized capabilities for supply chain application.
RFID readers operate on a UHF wavelength that does not require line of sight. That means all the contents of one case, pallet or even a storage room can be scanned at once – saving a great deal of time compared with manually scanning every individual item in a shipment. When the RFID reader establishes connection with a tag, it automatically collects data and improves efficiency by helping avoid unnecessary labor – for example, searching multiple caseloads looking for products that could have been located without opening any boxes. It also helps hospitals optimize inventory and automatically identify expired or obsolete products for removal.
Over the past several years, RAIN RFID technology has advanced significantly, becoming more reliable and more affordable than ever. The tags are now made with considerably more memory, so they can carry the same critical data as the new 2D barcode. RAIN RFID equipment also has longer read range and accuracy than earlier RFID technologies could offer. The infrastructure has expanded, with more readers available today at better prices and the cost of RFID tags has come down significantly, as well.
The Crucial Role of Standards
Data collection has limited value if it cannot be shared between supply chain partners and end users. GS1 Standards provide a common data language that enables information to be encoded, captured and shared in a consistent way across the entire supply chain, from manufacture to point of care. This enables stakeholders to accurately identify and locate products and communicate their status electronically in real time, giving healthcare providers necessary insight for ordering and inventory management, and providing new opportunities to adjust as needed, for example, if a product becomes unavailable or is delayed.
The standards that support healthcare supply chain visibility, transparency and traceability include the GTIN and Global Location Number (GLN) for unique identification of products and locations, respectively, along with Electronic Product Code Information Services (EPCIS), a global GS1 Standard for creating and sharing visibility event data.
Healthcare industry stakeholders worked together to develop a roadmap for supply chain partners to ensure they can capture, decode and understand information from the RFID tags. The “Implementation Guideline for RFID in Healthcare Manufacturing: Using GS1 Standards to Enable Visibility and Efficiency” document defines the application of GS1 Standards to support adoption of RFID by healthcare supply chain stakeholders. It informs pharmaceutical and medical device manufacturers about how to encode RAIN RFID tags using GS1’s Electronic Product Code (EPC) schemes outlined in the EPC Tag Data Standard (TDS) for automatic data capture to be utilized across the healthcare supply chain.
Supply chains are becoming more sophisticated to accommodate the needs of a rapidly evolving marketplace in healthcare. The benefits of better inventory management and visibility are universal, but when it comes to healthcare products, patient care and safety top the list, including U.S. regulations that govern the industry. RFID can be a powerful tool for improving healthcare supply chain management with real-time visibility, streamlined inventory management, and more effective recall management. Advanced data carriers like RFID tags and new 2D barcodes are opening new opportunities for industry collaboration and improvement whose time has come.