There is a big problem with counterfeit medical devices. Although the protection of patient safety is the main concern, any precautions taken indirectly protect health professionals in case of a problem. At AlpVision, we have a solution to verify the legitimacy of a device instantly with a smartphone.
Counterfeit medical devices – a big issue
Counterfeit medical devices are a big issue. However, this problem seems underestimated. A minimum of 8% of medical devices are counterfeit, which can become extremely serious if the counterfeit is of sub-standard quality. This problem is especially present in developing countries where the cost of genuine items is a significant part of people’s income.
Most of the counterfeit devices are entering the market via weaknesses in the supply chain. Therefore, it is necessary to secure the supply chain by systematically adding control points.
Protection of patient safety
Legal regulations exist in order to protect patient safety. Medical device manufacturers should ensure that the products conform with the law. For medical devices, a new regulation came into place in 2021: the Medical Device Regulation (MDR) 2017/745 (EU). This regulation includes, in particular, a Postmarket Surveillance (PMS), which means that manufacturers have to monitor medical devices after they enter the market and should also collect some data regarding their usage.
Patients should get advice from a health professional before using a medical device. Of course, this assumes that the supply chain is perfectly safe, which is not the case. Therefore, in order to protect patients’ safety, health professionals should be able to prove the authenticity of a device.
Protection of health professionals
The variety of medical devices is huge; from catheters to infusion pumps going through artificial pacemakers. Some are directly implanted by the health professional into the body of the patient, like aortic pumps, for example.
Therefore, if something goes wrong—like with the aortic pumps mentioned above where 7 million dollars’ worth of devices have been recalled because they were fake—the patient may consider the health professional responsible and file a lawsuit as a result. Therefore, health professionals are eager to make sure they are using a device that follows the regulations mentioned above and not a copy.
There are many ways of ensuring that a given medical device is genuine using a panorama of different anti-counterfeiting technologies. Operation Pangea VII was a project from the FDA which resulted in the seizure of a wide range of counterfeit medical devices ranging from bandages, contact lenses, spinal implants, and aortic pumps. It highlighted the need for anti-counterfeit solutions for medical devices.
Overview of solutions in place today to protect medical devices
Currently, the most well-known solutions to protect medical devices are the incorporation of micro-particles, the creation of a DNA signature, and anti-tampering.
The authentication can be combined with a unique serialization, which can ensure that a specific device is genuine and created according to the required quality standards.
The packaging of the devices is also often protected using holograms, security inks, and other methods.
AlpVision solutions to fight counterfeit medical devices
Medical devices often feature some plastic parts with a matte structure. This allows for the use of a technology which is extremely simple to deploy. Indeed, the technology is already there and there is nothing to add to the production process.
All that needs to be done in order to use AlpVision Fingerprint technology is to acquire a few reference images to protect the whole production.
This technology can basically be applied to any molded plastic product.
Tell us what your product is and we tell you if it can be protected.