Why Not Labeling to Fight Medical Device Counterfeiting?

by Craig Hodgson, on November 18, 2016

medical device labeling software

Imagine you go through hip replacement surgery only to find out that your new hip was
counterfeit—and defective—requiring the whole process to be repeated. Imagine the discomfort and health risk you have to endure, again. 

Imagine the potential lawsuit against the surgeon and hospital? Imagine the damage to the provider’s and manufacturer’s reputation. That’s the reality today as more and more counterfeit medical devices are infiltrating the market with no real way to stop it.

This important topic was recently addressed at a forum held by the Medical Development Group Boston (MDG Boston) where a panel of cross-disciplinary experts representing the manufacturing, regulatory, and legal fields gathered to share their insight. Each speaker provided a unique perspective with the overall goal of helping attendees better understand the crisis and how they can reduce the proliferation of counterfeit medical devices, components and supplies.

Some of the takeaways from the presentations included the need for manufacturers, regardless of their size, to implement safeguards like serialization to ensure a more secure, end-to-end supply chain. Companies must remain protective of their products, even as they move on to distributors, providers, right down to the patient. This becomes tricky with the Internet as counterfeiters are able to muddy the waters and introduce similar products at lower prices with little to no resistance. This is especially the case in international markets where there are less restrictions on the procurement and use of medical devices.

A member of the FDA was on hand to share that organization’s approach to stopping counterfeit drugs and medical devices from entering the US. A rigorous screening and testing process helps identify fake products, and includes the use of both overt and covert labeling and markings to determine the authenticity of products. The challenge is that the FDA is only so big and can’t monitor the influx of thousands upon thousands of medical devices into the country.

One approach that was raised but not previously considered is to leverage the Unique Device Identification (UDI) system currently being implemented on all classes of medical devices. By registering products with the FDA’s GUDID database and applying a barcode label with specific device and production identifier information, manufacturers can benefit from more precise tracking and tracing of their devices, which in turn leads to faster response in the event of a recall. Why can’t this labeling regulation also be used to help deter counterfeiters? With an industry-wide initiative designed to identify, track, and monitor the safety and efficacy of medical devices across the supply chain, wouldn’t it be more difficult for counterfeiters to penetrate this system with knock-off products?

The bottom-line conclusion, as agreed by the panel, is that counterfeiting is a major problem that has a negative impact on everyone throughout the health care ecosystem. As such, it’s important that manufacturers—even those in direct competition with one another—band together and treat counterfeiters as a common enemy. If you see something suspicious on the Internet or anywhere else, report it to the proper authorities. You may also be able to take legal action in many cases.

Hand in hand with being on the lookout for fraudulent products, medical device companies should also look at how they’re labeling their products. UDI requirements have already led manufacturers to implement a more systematic and accountable medical device labeling process. But as we learned in a recent survey on UDI compliance, some companies are more prepared than others. No matter where you are with your UDI readiness program, by deploying a standardized, centralized, and validated enterprise labeling solution, you can further protect the integrity of your products—and prevent counterfeiters from passing off an inferior product under your name.

Topics:Medical DevicesCounterfeitingRegulatory