Addressing the Counterfeit Epidemic for Medical Devices

The healthcare products industry has been plagued by counterfeiting operations which only seem to have worsened since the height of the COVID-19 pandemic. With limited oversight encouraging illegal activity, online marketplaces have served as the perfect platform for fraudulent and diverted medical products. The widespread consequences of fake medical products impact revenue for manufacturers, impose a safety risk for patients and practitioners, and threaten brand equity. 

 

The COVID-19 pandemic highlighted the scourge of counterfeiting in the medical supply chain. Authorities seized a significant number of illegitimate face masks, PPE, and unauthorized COVID-19 test kits within a few months of the pandemic’s onset¹. By early 2021, an alarming revelation had become apparent: healthcare facilities across several states had inadvertently acquired millions of counterfeit face masks². These incidents underscore the urgency to address the counterfeit epidemic before patient safety is again jeopardized by fake healthcare products. 

 

Illicit trade, specifically counterfeiting, diversion and tampering is now a global issue. While the World Health Organization (WHO) estimates that 1 in 10 medical products in developing countries is substandard or falsified³, counterfeit healthcare products are one of the most frequently seized commodities by U.S. Customs and Border Protection⁴.

In the fast-paced world of healthcare, ensuring the uninterrupted flow of critical medical devices and products is paramount. To overcome these challenges, organizations should utilize tracking and tracing technology. Transparent product data, digital connectivity and real-time supply chain visibility help ensure products safely reach medical providers and their patients.

Vital critical processes to successfully track and trace products include: 

• Lot-level Management: This preliminary phase involves tracking products at the batch or lot level, ensuring the first layer of traceability and verification in the distribution process.

• Item Serialization: This phase mandates that manufacturers, repackagers and wholesalers uniquely mark individual product units, establishing a synchronous connection with each item and enhancing the traceability and authentication processes.

• Serialized Traceability: This phase creates a secure and interoperable electronic system that facilitates the seamless sharing of product information with trading partners and the verification of product information. This comprehensive network is designed to strengthen transparency and accountability across the entire pharmaceutical supply chain.

• Product Authentication: This step assures your customers that the products they are using are genuine, while also instilling confidence in sellers that they won’t lose customers or face warranty issues—or worse, lawsuits. Effective supply chain management includes ensuring products cross borders smoothly. Manufacturers have trained border patrol to identify counterfeit products, but shipments can be delayed in customs if there’s no straightforward way to authenticate them.

A layered approach creates and captures product identification data at the packaging line level to deliver value throughout the medical product supply chain. Designed to meet the needs of each organization, integrated vision inspection, device management, line control, and workflow management should be backed by well-grounded implementation and expert support.

 

An ecosystem of shared responsibility and vigilance materializes when all authorized trading partners securely and electronically distribute transaction statements and information. A vital detail of this collaborative effort is the role of wholesalers in verifying all returned products before they can be reintroduced into the supply chain, adding an additional layer of safety. 

One successful approach is to use existing product barcodes—like the Unique Device Identification (UDI) required for all medical devices—to create a digital fingerprint that individually identifies each product, confirming authenticity wherever a device may go. 

 

Successful traceability and product authentication support patient safety initiatives that drive regulatory requirements, including the US UDI and Global Unique Device Identification Database (GUDID) and EU Medical Device Regulation (EU MDR).  As these regulations evolve, regulatory agencies recommend that manufacturers continue to improve processes to ensure protection.

Technology is critical in today’s battle against counterfeiters. Digital fingerprinting creates a unique digital identifier through vision technology, facilitating authentication anywhere using a smartphone⁵. Artificial intelligence (AI) and machine learning tools can conduct real-time analysis of large datasets. This technology identifies potential counterfeit products by meticulously detecting inconsistencies, while associated business intelligence and forecasting functions streamline operations, lowering costs and increasing efficiency. 

 

Equipping the medical products supply chain with all the pieces necessary for traceability is no small feat. However, investing time and resources strategically will benefit the industry now and well into the future. By adopting layers of product protection needed for today’s supply chain and leveraging technology for enhanced security, manufacturers can secure products effectively, protect brand reputation, and ensure the safety of patients worldwide.