Medical Device Counterfeiting and How to Avoid It

Medical Device Counterfeiting and How to Avoid It

21 Feb 20182 min readMike Anderson
Operating room Operating room

Last year, MPO magazine addressed the growing global problem of medical device counterfeiting.

The article stated:

Counterfeit medical devices pose a serious and escalating threat to U.S. patients. While the FDA has taken some action to remedy the situation through its Unique Device Identification (UDI) legislation, the move falls well short of what could and what is being done in other industries.

Figures representing the percentage of counterfeit products in the market, some research show the number as high as 8% internationally.

How much money is this growing epidemic costing your company, and what can be done to protect your device?

ATL Technology has three solutions that can limit the use of your interconnected device.

How can I protect my device from counterfeiters and pre-processors?

ATL has created three means of limiting the number of times a device can be used, disabling the devices ability to function if it isn’t mated into a corresponding piece of equipment, along with other advancements and technologies.

We refer to these benefits as Use Limiting Technologies, and refer to each as:

  1. Mechanical Use Limiting
  2. Radio Frequency Identification Limiting
  3. Single Wire/Electronic Limiting

What is Mechanical Use Limiting (MULS)?

The characteristics of MULS is as follows:

  • Preset number of uses
  • Compatible with all common sterilization methods
  • Inexpensive
  • Use limitation only (no counterfeit) detection/prevention

What is Radio Frequency Identification Limiting (RFID)?

The characteristics of RFID are as follows:

  • Wireless communication
  • Cable authenticity
  • Previous use validation
  • Counterfeiting made difficult (not impossible)
  • Does not consume any connector pins
  • Requires capital equipment alignment

What is Single Wire / Electric Limiting?

The characteristics of Single Wire Limiting are as follows:

  • Fuse across two pins in the connector
  • Capital Equipment checks for circuit
  • Requires capital equipment alignment
  • Power “blows” the fuse
  • Compatible with all common sterilization methods
  • Inexpensive
  • Use limitation only (no counterfeit detection/prevention)

With the ever-increasing problem of device counterfeiting, the need for security across the entirety of the device is of paramount importance.


Additional resources.

At ATL, we specialize in the design, development, and production of devices that are connector based.

If you are in need of, have questions about, or see how your application could benefit added security from something like ATL’s use-limiting technology, please contact us.

To learn more about how to overcome some of the challenges of developing an energy-driven device, download our free eBook.