Product traceability is an increasingly dominant concern in healthcare, partly due to regulations like the FDA’s Unique Device Identification (UDI) Rule for medical devices and the Drug Supply Chain Security Act (DSCSA) for pharmaceutical products. Widespread disruptions since 2020 have also exposed critical supply-chain vulnerabilities caused, in part, by a lack of visibility — with negative consequences reaching all the way to the point of care, further underlining the need for change.
Meanwhile, RAIN RFID technology has advanced significantly over the past several years, becoming more reliable and more affordable than ever. RAIN RFID specifies use of the UHF frequency band, which leverages the GS1 air interface protocol to communicate with tags. With longer read range and accuracy, expanded reader infrastructure, and lower tag costs, RFID is now considered a viable solution for tracking healthcare products through the supply chain.
Full supply-chain visibility enabled by real-time, electronic communications between trading partners can help prevent inefficiencies, delays, and even critical shortages of healthcare products by enabling precise inventory of products by location throughout their life cycle. Building more resilient, technology-based supply-chain management systems can better ensure the availability of critical medical supplies when and where they are needed.
Manufacturers, providers, retailers, and patients all depend on a complex system to deliver products from point A to point B. Snarls in the system are nearly impossible to untangle without a clear view of existing inventory, its location, chain-of-custody, and traceability data, all predicated on unique product identification.
RFID technology enables automated identification and tracking of devices at every stage of the supply chain. Each medical device can be equipped with a RAIN RFID tag that contains its UDI and other attributes such as serial number, batch/lot, and date. When based on GS1 standards, the device identifier is expressed as a GS1 Global Trade Item Number® (GTIN®). As these devices pass through various checkpoints, RFID readers capture the data stored in the tags, providing real-time updates on their location, movement, and status.
A company’s ability to exchange information about products moving through the supply chain is crucial for safe, efficient delivery of goods. GS1 standards provide the common language that enables information to be captured and shared in a consistent way across the entire supply chain, from a product’s point of origin to its point of sale or use. As a result, products can be accurately identified and located at any time and place, and their status can be communicated electronically between stakeholders in real time. This gives companies necessary insight for ordering and inventory management, and provides new opportunities to adjust as needed, for example, if a product becomes unavailable or is delayed.
The standards that unlock supply chain visibility, transparency, and traceability include the GTIN and Global Location Number (GLN) for unique identification of products and locations, respectively, along with EPCIS (Electronic Product Code Information Services), a standard for providing event and transactional data. Scanning the RAIN RFID tag captures movements of a product at each stop along its journey.
Streamlining Inventory Management
Efficient inventory management is crucial to ensuring the availability of healthcare products for timely patient care. RFID technology offers significant advantages over traditional inventory systems by automating data collection and minimizing manual interventions.
By efficiently and accurately tracking the movement of devices, healthcare providers can optimize inventory levels, reduce stockouts, and eliminate the risk of expired or obsolete products. This streamlined approach helps ensure that healthcare professionals have access to the right devices at the right time, ultimately improving patient care.
Enhancing Recall Management
Timely identification and retrieval of recalled or expired products is crucial to protect patient safety. RFID technology simplifies and expedites the recall process by providing a mechanism for fast and precise tracking. When necessary, healthcare providers can swiftly identify affected products using RAIN RFID data and trace them back through the supply chain to their exact locations.
They can gain even greater visibility utilizing the Electronic Product Code Information Services (EPCIS), a global GS1 standard for creating and sharing visibility event data. This capability not only facilitates efficient product retrieval but also minimizes the time and effort required to notify patients and healthcare professionals, supporting rapid response to prevent any adverse events.
Healthcare industry stakeholders worked together with GS1 US to identify how manufacturers should encode and provide a roadmap to assist the industry in RFID adoption for supply chain improvement. The “Implementation Guideline for RFID in Healthcare Manufacturing: Using GS1 Standards to Enable Visibility and Efficiency” is designed to ensure all recipients of tagged products can decode and understand the product information using GS1’s Electronic Product Code (EPC) schemes outlined in the EPC Tag Data Standard (TDS 2.0). 1
Modernizing the healthcare supply chain with digital technology has become an imperative to enable far more robust track-and-trace capabilities throughout product life cycles. The industry is already implementing DSCSA and UDI requirements to enable more effective traceability and beginning to use more advanced data carriers for product and location identification. RFID has potential as a powerful tool for improving healthcare supply chain management with real-time visibility, streamlined inventory management, and more effective recall management. As the industry continues to implement new supply-chain solutions like RFID for improved visibility, patients can look forward to a future where timely access to critical drugs and medical devices is assured, and the quality of care is greatly enhanced.
- “Implementation Guideline for RFID in Healthcare Manufacturing: Using GS1 Standards to Enable Visibility and Efficiency,” GS1, Ewing Township, NJ.