Fighting Counterfeit Medical Devices Protects More Than Just Patients

 

Topical Absorbable Hemostat, a medical device, is commonly used during surgical procedures to control bleeding. Imagine if a surgeon puts the device into a patient’s body, but finds out the product isn’t performing well as it’s an instance of counterfeit medical devices. In the worst-case scenario, the surgery might fail, not only harming the patient but also putting the doctor and the hospital at risk of medical negligence and litigation.

While the scenario might seem rare, it’s a real-life example. A neurosurgeon discovered a counterfeit topical hemostat just before he was about to introduce it into the patient’s brain. The device might be unknown to the public but it is routinely used in surgeries.

So, counterfeiting isn’t a problem for only the patients, but equally puts health professionals at risk, that too, at no fault of their practice. In 2010, WHO estimated that a minimum of 8% of medical devices are counterfeit. And in 2020, counterfeit pharmaceutical sales were estimated to be between $200 billion and $431 billion annually.

This can become extremely serious if the counterfeit is of sub-standard quality. The problem is especially present in developing countries where the cost of genuine items is a significant part of people’s income.

What Are Counterfeit Medical Devices?

Counterfeit medical devices are falsified replicas of genuine and trademarked medical products. They are typically manufactured under substandard supervision without adhering to the regulatory standards of the industry.

Examples of such counterfeit products include surgical instruments, diagnostic equipment, and consumables like syringes and contact lenses. Most counterfeit devices enter the market via weaknesses in the supply chain. Thus, it’s necessary to secure the supply chain by systematically adding control points.

Types of Medical Devices Commonly Counterfeited

To understand the types of devices counterfeited, we have to understand the motive behind counterfeiting. Counterfeiters only care about their financial gain, with little regard for the potential harm caused to patients and healthcare providers. In 2016, the counterfeit drug detection devices market alone was estimated to be worth USD 904.5 million.

So, a wide range of medical devices are counterfeited. From products used by the common public like contact lenses to surgery equipment like aortic pumps. Some of the most commonly counterfeited devices include:

• Surgical Instruments like surgical mesh
• Diagnostic Equipment like blood glucose meters, pregnancy tests, and cholesterol monitors
• Consumables like syringes, contact lenses, and surgical gloves
• Implants and Prosthetics like hip and knee replacements
• Personal Protective Equipment (PPE) including masks, gloves, and gowns

Risks of Counterfeit Medical Devices

The risks of counterfeits are two-fold, one to the patients, and the other to the healthcare professionals.

Risks to Patient Safety

The most direct and devastating impact of counterfeit medical devices is on the patients. For example, the epinephrine auto-injector, a common medical device, saves lives in emergency and dangerous medical situations. People with a history of anaphylaxis (allergic shock) usually keep them at home for unfortunate emergencies.

Imagine a situation where a kid gets a sudden allergic reaction, the caregiver rushes to find the injector and injects the medicine. However, the allergic reaction doesn’t stop – what was wrong with it? If the child doesn’t receive medical attention immediately, a life would be lost. All because of the injector being a counterfeit medical device.

The impact of a counterfeit device ranges from misdiagnosis to fatal death:

1. Ineffective treatment: Low-quality devices don’t perform as intended, leading to misdiagnosis and inappropriate or delayed treatment.
2. Increased morbidity and mortality: Substandard medical devices could lead to severe health complications and even death in some cases.
3. Exposure to toxic substances: Counterfeit devices are made from inferior materials, which could contain harmful substances. This can lead to infections, allergic reactions, or other severe health issues.
4. Lack of efficacy: In cases like counterfeit insulin pumps or blood glucose meters, patients might receive the wrong dosage or false readings, putting their lives at risk.

Protection of Patient Safety

Legal regulations exist in order to protect patient safety. Medical device manufacturers should ensure that the products conform to 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, 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.

The FDA also passed the Safeguarding Therapeutics Act in 2020. Before the act was passed, the law enforcement authorities could re-export any imported counterfeit devices. This allowed the counterfeits to enter back into the supply chain. But now, the FDA can destroy any counterfeits that enter the US market, thus breaking the cycle.

Patients should also 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.

Risks to 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 that 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.

Current Solutions 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, barcodes, and RFID tags.

Governments and international organizations are also working on establishing stringent regulatory frameworks to ensure the authenticity and safety of medical devices. Regulatory agencies like the FDA and EMA conduct rigorous inspections and audits to prevent counterfeit devices from entering the market.

The Best Solution to Fight Counterfeit Medical Devices

While the existing measures are effective to some extent, counterfeiters are getting more sophisticated. This calls for more innovative solutions. For example, AlpVision Fingerprint is a patented and unique technology, almost impossible to replicate.

AlpVision Fingerprint uses a non-intrusive method to secure medical devices. Unlike traditional anti-counterfeiting measures, AlpVision Fingerprint does not require any additional markings or modifications to the product. Instead, it leverages the inherent microscopic surface irregularities of the product to create a unique “fingerprint.”

Here are some key features of the technology:

• Unmatched security: The unique fingerprint of each device is virtually impossible to replicate, providing a highly secure method of authentication.
• Non-intrusive: Since it uses the natural surface properties of the device, there is no need for additional labels or markings, preserving the integrity and functionality of the product.
• Easy verification: Healthcare professionals can easily verify the authenticity of a device using a standard smartphone. This makes the checks quick and efficient in any setting.
• Comprehensive protection: AlpVision Fingerprint can be applied to a wide range of medical devices, from surgical instruments and diagnostic equipment to consumables and implants.
• Cost-effective: The technology is cost-effective, as it does not require significant changes to manufacturing processes or additional materials.

Guard against the fakes with advanced device security

The safety of public health and healthcare providers depends upon genuine medical devices. Today, counterfeiters are not scared to create replicas of sophisticated devices like catheters or implants. The technology they have access to is continuously getting better. When they can counterfeit such complicated devices, a mere hologram or barcode can’t stop them.

To keep up with the counterfeiters, the healthcare industry has to tap into advanced and innovative technological measures like AlpVision Fingerprint. The technology can be applied to any molded plastic product, making it accessible to a wide range of products.

But if you have a specific product, don’t hesitate to reach out to us.

 

Contact Us