Thwarting Counterfeits in Medical Devices

Medical devices don’t come cheap. With MRI machines, PET/CT scanners, surgical robotics and other technologically sophisticated equipment running into millions of dollars, healthcare providers are keen to use them as long as possible. It’s a targetrich environment for counterfeiters who know they’ll be in the market for repair and replacement parts when a component fails—most inconveniently after the component manufacturer stops production.

It can be tempting to source replacement parts from the grey market, especially when classified as obsolete or nearing end of life. However, that’s a big gamble when reputations and patients’ lives are on the line. Unauthorized parts are rarely, if ever, in step with the component manufacturer’s quality standards. Yet the grey market’s siren song echoes through the supply chain. Is it alluring? Yes, but it can also be harmful.

It can be hard to tell counterfeit parts from their OEM authorized brethren. For some, it is a crime of opportunity, stripping e-waste of its valuable bits and sloppily replacing the serial numbers. Savvier counterfeiters, however, may produce parts that mimic the real deal, from impeccable finishes to unassailable paper trails. Complex global supply chains provide a bevy of entry points.

Counterfeiters and those who seek to thwart them play a cat-and-mouse game. As authentication and anti-counterfeiting technologies get more sophisticated, so do forgers’ methods. Some produce newly minted fakes. Others focus on parts designed for multiple use cases and long product lifecycles that may recirculate for years. Here’s a sobering thought: more than one trillion semiconductors were sold globally in 2022. If just one percent of them are fake, that’s 10 billion—some of which are likely in medical devices.

Chips aren’t their only target, and it is the rare category or component OEM that remains untouched. Common problems in the grey market stem from: e-waste, forgery, cloning, reverse engineering, defective/ out-of-spec components and Trojan software.

There are numerous worldwide standards governing medical device manufacturing, post-market surveillance and adverse event reporting that seeks to ensure medical devices remain safe and perform properly in use. The WHO Global Model Regulatory Framework for Medical Devices supplements those already in play, defining the post-market surveillance roles and responsibilities of patients, healthcare providers, manufacturers and national regulatory agencies.

It offers standardized problem categories for targeted analysis, such as A05 for mechanical actions or defects and A07 for electrical circuitry failure. Its recommendations for feedback, reporting, data collection and data analysis stand to coalesce a wealth of data for those seeking to foil counterfeiters, serving as a welcome counterpoint to authorized distribution.

Components classified as obsolete or no longer available via authorized sources account for almost half of those counterfeited, followed by allocated parts that are still being produced but have long lead times. Forgers don’t limit their activity to hardto-find parts; even those readily available from OEMs and their authorized channel partners are in their crosshairs.

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