Drug and medical supply manufacturers operate in heavily regulated environments where assigning lot and serial numbers to their high-value, highly customized products is required for better visibility of the supply chain. The growing use of lot and serial numbers for increased traceability also allows practices to better track their medical inventory from purchasing to dispensing.
Serial numbers are unique identifiers assigned to each individual item within a batch (lot) of products, which have a lot number to identify the products that were manufactured in the same batch. Unlike a traditional SKU, serialization gives companies the ability to track each product individually, making it easier to manage warranties, achieve industry-related compliance, and manage post-market surveillance where required. A group of products may have the same lot number, but serial numbers will differentiate them from one another.
Both lot and serial numbers enable tracking of each individual item from the time it’s manufactured to when it’s delivered to the patient. So, the entire history of the product is laid out for better reporting and compliance.
The use of lot and serial numbers enable manufacturers and government agencies to track products end to end in each step of the supply chain, from the moment they are manufactured to when it’s dispensed to patients.
There are many benefits associated with lot and serialized tracking, including:
Greater accuracy
Serialization and tracking provide an accurate picture of the entire lifecycle of a product. By tracking products throughout their manufacturing, distribution, and usage phases, managing quality control issues, identifying expired or counterfeit products and accelerating product recall processes become easier. Lot and serial numbers enable manufacturers and government agencies to track specific purchase orders and customer records, providing greater visibility and insight.
Improvement Claim Management
Expensive medical devices such as oxygen machines, ECG equipment, scanning devices and others have comprehensive and complex warranties attached. Serialization reveals information that can make it easier to determine valid warranty periods, trace errors and defects, manage maintenance and even provide insights required before carrying out repair activities.
Faster Recalls
Medical equipment and drug recalls can impact patients and businesses negatively. The risk to a company’s reputation is significant, especially if a patient falls ill as a result of a defective or contaminated product. Serial and lot tracking can improve the recall process by improving traceability so that affected lots can be traced and recalled quickly. It can also avoid blanket recalls by laser-focusing on problematic lots. Lot tracing collects each lot into simple, identifiable units with a unique ID number so that every defective product within the batch can be tracked and pulled from the market, managing the costs and the fallout from the recall more effectively.
Compliance Standards
Serial numbers and product tracking is mandated for drug manufacturing and biotech companies as governments clamp down on counterfeiting and safety issues. The Food and Drug Administration (FDA) requires manufacturers to track specific Class I, II and III devices through the entire distribution chain when an order is received from the FDA to implement a tracking system. The Drug Supply Chain Security Act (DSCSA) implemented a system to track and trace prescription drugs with the goal of establishing unit-level traceability in the United States, while the European Union Medical Device Regulation implemented regulations to improve transparency into the use, safety and performance of medical devices throughout their lifecycle across the European Union. Companies operating in these territories and industries must comply to avoid harsh penalties.
Theft and Counterfeiting Prevention
Unique serial numbers can be used to prove ownership in cases of theft or missing stock and aid law enforcement with returning an item to the rightful owner. It also prevents competitors or malicious characters from swapping/selling inferior products, which is especially important for medical device companies designing equipment to preserve the health and wellbeing of patients.
Lot and serial number tracking enable practices to comply with regulations, easily track buy and bill medication, minimize waste by using the products with the closest expiration dates, and have full visibility of their inventory life-cycle.
Yet, finding the right technology solution is crucial. Providers should look for inventory management solutions specifically designed for the medical world and streamline specialty-specific workflows (where lot and serialized tracking is one) to optimize their inventory operations.
ElevateHT provides innovative solutions for medical inventory management that are tailored for each specialty. Facilities that use Pulse easily track lot and serial numbers, simply by scanning the data matrix on a given item while receiving it against a purchase order. Businesses can also auto-assign serial numbers in order to track items individually down the line.
With our software, medical offices can;