Counterfeit medical devices present quite a few problems to the medical field. Although they might look and function just like their approved medical device counterparts, they might consist of the wrong materials, could be poorly made, and can even be non-sterile. Fraudulent medical devices hurt competition, brand names, and even impact employment and tax income. Most importantly, counterfeit medical devices present severe health risks for patients; faulty devices might not be discovered until it’s too late.
Counterfeit devices have become more of a problem because of how easy it is to market items on the internet. The FDA is depending on unique device identification (UDI) to track and identify medical devices, which, in turn, should help medical facilities prevent counterfeiting and prepare for other emergencies.
What is UDI?
Unique device identification is a system established by the FDA that will accurately identify medical devices as they are distributed and used. Once fully implemented, medical devices will require labels – known as unique device identifiers – that can be read by humans and machines alike. Any facility that utilizes these labels will have to submit device information to the FDA’s Global Unique Device Identification Database (GUDID), which can be searched by the public.
How will UDI prevent counterfeiting?
To be more specific, a UDI is a unique numeric (or alphanumeric) code that includes a device identifier (specific to a device’s model) and a production identifier, which includes information like serial numbers, batch/lot numbers, and an expiration date. These labels can be read by AIDC technologies, like linear or 2D barcodes.
As it is currently, a certain device might have multiple item codes, depending on the manufacturer. Alternatively, different devices might share the same item code. When UDI is fully implemented, distributors will no longer have to worry about multiple manufacturers offering the same item codes.
UDI eliminates all confusion from the equation. Counterfeit medical devices are sometimes incredibly deceptive; if the naked eye cannot tell the difference between authentic and counterfeit items, mistakes can be made. A single, comprehensive system of device identifiers that cannot be replicated is the best way to ensure that counterfeit devices are detected.
How can UDI help medical facilities prepare for emergencies?
The biggest problem with counterfeiting is that it puts patients at extreme risk of injury or death. With UDI fully implemented, medical facilities will be more prepared for emergencies because they will have the correct, approved devices on hand. If counterfeit items can be eliminated completely, the risk of malfunctioning or improperly sterilized devices is almost entirely eliminated.
In an industry that works to improve the wellbeing of the population, spurious devices are an extreme threat. Second chances are few and far between in life and death situations, so having the correct device on hand is paramount. Unique device identification is the best option there is when it comes to reducing counterfeiting. The FDA is currently rolling out implementation deadlines, with the final year being 2020. If all goes well, counterfeit devices in the medical field will soon be a thing of the past.
