The ability to track and trace products is crucial for comprehensive supply chain management. Traceability solutions have long been recognized for their ability to protect against counterfeits and ensure more effective recalls. According to the U.S. Food and Drug Administration (FDA), the tracking provision dates back to 1993. Over the years, healthcare traceability has evolved and in November 2013, the Drug Supply Chain Security Act (DSCSA) became law. The law requires pharmaceutical drug and device manufacturers to facilitate product traceability by 2023. Manufacturers, licensers, dispensers, and distributors must track, collect and share product data at every stage of the supply chain.
Product integrity is a constant facet of importance for supply chain professionals. Many of these issues occur because the current supply chain lacks transparency and visibility in every single stage of the journey. Fortunately, traceability solutions can eliminate such risks by keeping track of the entire supply chain. Some Class II and Class III devices are subject to the Medical Device Tracking Regulations. Similarly, GS1 standards support the traceability of medical devices across the supply chain.
This article explores the three main benefits of traceability to the healthcare industry.
But first, what is Traceability?
Track and Trace technology or simply traceability refers to product tracking. Traceability is the ability to follow the movement of products at particular points of the supply chain as well as the ability to trace the location, history and storage parameters of the products.
According to GS1, traceability in healthcare enables a person to see the backward and forward movement of medical devices across the supply chain. Backward tracing shows the history of transfers and locations of a product from the point of manufacture. On the other hand, forward tracing shows the route followed by the product up to the point of care.
Benefits of Traceability to the Healthcare Industry
There are numerous benefits that any business in the medical sector can derive from traceability systems. Traceability isn’t just about compliance but it’s about taking the opportunity to improve business operations, quality and consumer trust to gain a competitive advantage.
Here are some of the benefits of traceability:
Integrity of Products
Electronic Product Code Information Services (EPCIS) is one of the GS1 standards that require trading partners to share data about a product’s movements through the supply chain. Trading partners must share information on the what, when, where and why of the products. The goal is to increase supply chain integrity. The traceability technology can autonomously record and transmit data about the condition of the product, including any evidence of product tampering to ensure product integrity. Traceability, therefore, ensures that only authorized medical products circulate in the supply chain.
Traceability also helps to deliver customer value. Manufacturers are able to deliver the promised product offerings to consumers. A manufacturer records virtually every movement of a product and consumers can access full information of the cradle-to-the-grave journey of specific brands. Allowing customers to verify the products can aid in confirming that the device originates from legitimate manufacturers and have been handled correctly throughout the supply chain. Traceability hence increases the integrity of products by reassuring the end user that the items are genuine and sterile.
Minimization of Product Loss
There are risks for losing products at any point of the supply chain. Inventory can go missing due to accounting errors or dishonest workers which negatively impacts profits, efficiency, and compliance. Traceability systems are reliable in tracking shipments, administering recalls and ensuring reliability at every step of the supply chain. The technology eliminates the loss of products by providing real-time visibility as items make their way to distributors and retailers. Traceability systems as a consequence assist organizations to minimize inefficiencies and mistakes that bring unbudgeted costs.
Quality Control over Products
The aim of the DSCSA is to transform the supply chain. Traceability of medical products has potential advantages such as ensuring fewer counterfeit products. It also ensures correct shipping and storage conditions especially for temperature-controlled products thereby reducing damages. According to Berlinger, Beyond the Cold Chain, traceability to a greater extent permits manufacturers to exercise quality control over their products by ensuring correct handling.
Traceability further allows manufacturers to exercise control of the products by reducing the chance of expired products being sold and preventing the distribution of recalled products. Traceability technology enables manufacturers to expeditiously remove defective products from the market. Traceability systems are also able to notify distributors when the products are nearing the expiration dates. Product scanners and barcodes ensure that expired products are removed from the warehouses and shelves. As a result, traceability plays a great role in helping devices maintain their efficacy throughout the supply chain.
In the past few years, traceability has been the new watchword in the medical industry. Despite tracking being a law in the industry, traceability is going to have potential benefits for manufacturers, suppliers (such as Surgishop), buyers and healthcare consumers. Utilizing traceability offers a wealth of capabilities that support any business in the medical device industry by improving product integrity, minimizing loss of products and having comprehensive quality control over the products.
Berlinger. (n.d.). Beyond the Cold Chain. Retrieved from https://www.berlinger.com/fileadmin/user_upload/news/berlinger-ag/0094_0038_Berlinger_Whitepaper_A4_Berlinger_low.pdf
FDA. (2018). Medical Device Tracking. Retrieved from https://www.fda.gov/medical-devices/postmarket-requirements-devices/medical-device-tracking
GS1.Org. (2019). Healthcare traceability and GS1 standards. Retrieved from GS1: https://www.gs1.org/industries/healthcare/traceability
WHO. (n.d.). WHO to work on a policy position on the introduction of track and trace technologies and standards. Retrieved from World Health Organization: https://www.who.int/medicines/regulation/traceability/en/