With reports of fraudulence increasing, counterfeiting of medical devices poses a significant threat to patients. Unfortunately, little is being done to address this growing problem. In fact, while there are a number of effective technologies to address diversion and counterfeiting, too many device manufacturers are operating on a “leap of faith” belief that their products are secure without these technologies.
If protecting medical devices provides significant value for the areas of patient safety, brand protection, differentiation, and supply chain efficiencies, why are medical device manufacturers hesitant to adopt anti-counterfeiting measures? It seems as if these companies leave themselves open to significant liability by not adopting the very products that could provide an effective layer of security to ensure patient safety. A quick review of the various technology options readily available reveals that there are a number of anti-counterfeiting and anti-fraud products available today that provide a wide range of reliable options for brand protection. These products make use of the latest technology in anti-diversion, anti-counterfeiting, and anti-fraud printing methods to offer durable, easy-to-apply, and relatively affordable ways to guard against medical device product fraud and maintain consumer confidence and safety. Overt features offer significant value in that consumers are able to see that security steps are being included by the manufacturer. Many of the overt features can be embodied with covert capabilities, which help provide track and trace, as in RFID and other technologies. Additionally the overt/covert features can also be used to flag quality processes like sterilization, cold chain management, etc., creating value in more ways than one.These types of technologies include:
Holography - Featuring specialized coating technologies, holography for medical device companies can be embedded images that can include messages, barcodes, photographs, and more.
Serialization - Random serialization (RSS) includes such pertinent information as lot code and expiration date, offers fill service with data management and additional functions, and provides human readable code and capability for verification through online or telephone systems.
Color Shift - Unique colors are available that can be assigned to individual companies and can be used to track diversion. These could be accomplished through pigments, thermochromic, or photochromic inks.
Tamper Evident - Frangible materials that leave behind a signature code on the package. Patterned adhesives are also available.
The medical device supply chain is simpler than that of pharmaceuticals and offers significantly easier ways to protect it. This overlay illustrates the type of security features required across the elements of the supply chain. |
Counterfeiting of medical devices poses a significant threat to the patients. Perhaps the most viable approach for medical device manufacturers is through RFID, by using active or passive RFID tags. When properly applied, this technology provides several key benefits. These include inventory cost savings of the various parts that go into a medical device, manpower cost savings when assembling these parts into a kit, tracking devices in critical need, tracking returns and rebates, and the provision of an additional form of authentication.
It is heartening to note that numerous medical device manufacturers have begun to actively test RFID in several ways and that they are finding applications that create tangible value for them and the end users.Patient safety and the adoption of track-and-trace anti-counterfeiting will increase significantly if the industry looks at the waste going on in their supply chain. This can also serve to help reduce device costs to the consumer, as the product will move more efficiently before it gets to the end user. Technical solutions through packaging and data management systems are available today, providing the necessary means to track a product. And the adoption of anti-counterfeiting techniques provides a significant incentive for manufacturers to better understand how their products move through the supply chain, thereby gaining better control of the products being dispensed in a reliable manner. It is prudent for medical device manufacturers to do more with the available track-and-trace anti-counterfeiting technologies in promoting patient safety, before one of their brands shows up in the headlines and they have to fight to save it and their reputation. The business process of delivering devices to the consumer will change in time, providing a safer and secure chain for us all. Now is the time to begin that process.
Dr. Narendra Srivatsa, business development manager for New Jersey Packaging, holds a Ph.D. in chemical engineering from SUNY at Buffalo and an undergraduate degree of Bachelor of Technology in chemical engineering from I.I.T. Madras, India. He has been awarded numerous process and product patents, many of which have been commercialized or licensed. A member of the American Chemical Society, NJPHAST, and other professional organizations, Narendra is an innovator and a business builder with a track record of over 16 years in industry.