Over 8% of medical devices in circulation are counterfeit: WHO

Counterfeit medical products are becoming an international epidemic. According to the World Health Organization (WHO), more than 8% of the medical devices in circulation are counterfeit. The offending products may be assembled from inferior quality components, or worse yet, from fake parts that could contain toxic materials. In either case the dangers are the same. Counterfeit medical devices pose a significant liability to the manufacturers and a health risk to both the patients and healthcare providers that could result in injury, permanent disability, or even death.

In response to the growing threat of counterfeit medical products, WHO created the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to raise awareness, mobilize nations, and draft international legislation. Over the past few years, the Food and Drug Administration has reported numerous counterfeit medical products in the U.S. like unsterile surgical bandages, faulty glucose test strips, and fake pharmaceuticals. In 2009, U.S. Customs seized over $30 million in counterfeit medical products, including pharmaceuticals, personal care products, electronic components, and power systems.

While domestic and international organizations are doing their best to fight the counterfeiting threat, there are many reasons for medical device manufacturers to become more proactive in protecting their brands. "The potential health risks to consumers aren't the only dangers," explains Steve Delepine, V.P. of Business Development for BrandWatch Technologies. "The effects of legal liabilities, negative branding, and revenue loss can ultimately bankrupt a company."

The medical industry presents unique challenges to brand security. Medical device manufacturers need a security partner capable of implementing protection strategies with qualifying cGMPs (current Good Manufacturing Practices) that won't slow or disrupt established production flows. Delepine emphasizes, "BrandWatch is an organization familiar with pulling together varying resources to monitor the product's entire life cycle - from contract manufacturers, to healthcare administrators, all the way to the customer."

In addition to quality and experience, in-depth knowledge of counterfeiting techniques is essential. "Too many companies spend a lot of money on a security solution which will be duplicated or obsolete in six months," Delepine warns. "A brand protection plan that doesn't include an evolving design is no plan at all. Counterfeiters just move too fast." BrandWatch's unique technologies offer security solutions which are predesigned to change and adapt without having to be customized or recreated every time, keeping one step ahead of the counterfeiters, and ultimately saving time and money along with the brand.


BrandWatch Technologies


  1. Paul Brown Paul Brown United Kingdom says:

    I work for a company that specialise in trademark infringement though I used to be in medical device research and development, spending many enjoyable years at Femcare. We specialise in the electrical industry but curiosity got the better of me, aware as I am of counterfeit drugs available I looked up counterfeit devices to see if there were any similar correlation with the drug market. Suprisingly it seems everything has counterfeit alternatives of varying quality, even when it comes to life saving devices. I am well versed in the development to market route and know it is costly and time consuming, I would be interested to find more accurate information and any specific examples.

  2. Walid Mokni Walid Mokni France says:

    I am a public health pharmacist. Following the same way of thinking as Paul, I am doing a research on counterfeit medical devices. First of all, I was unable to find the WHO reference used for this article, or any other work quantifying this phenomenon. Indeed, data on counterfeit medical devices are very scarce and, as far as I know, no review is available. I would also be very interested if someone had any assessment of medical devices counterfeiting or known cases. Thank you.

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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