Could a medical device you use be a fake?

Would it shock you to know that 8 percent of medical devices -- including things like plates, surgical mesh and screws that are meant to be inserted inside the bodies of patients -- are fakes?

It would most people. Even many doctors are unaware of how common counterfeit medical devices actually are. It's a worldwide problem, including in the United States, because many real medical devices are shipped in from manufacturers far away -- making it far too easy for cheap replicas to make their way into the mix.

The problem includes devices that are meant for home use, like thermometers and blood pressure cuffs, which can result in tragedy when the devices don't work properly and give patients misleading information about their health. Patients who rely on incorrect information may miss important clues that their lives are actually in danger -- which ultimately defeats the whole purpose of using a device at home to self-monitor.

The issue is further aggravated by the fact that it isn't just whole devices that are being counterfeited. In many cases, it's just some of their more-expensive components. Those end up being used in the manufacturing process for the end device -- but the cheap pieces start to quickly malfunction once those devices are put into use. That can result in a number of problems for both patients and doctors, including:

  • Diagnostic errors
  • Poor therapeutic results
  • Unreliable responses on critical tests
  • Increased medical costs
  • Delayed diagnosis
  • Injury or death

Because the issue of counterfeit medical products is so well-known, hospitals and diagnostic centers have a duty to try to mitigate the risks their patients may face. When they procure new medical devices, the people in charge need to be extra cautious. That means:

  • Checking the marks and serial numbers on devices and their components
  • Carefully looking into a supplier's history and background
  • Auditing the work of any maintenance companies hired to do repairs or replace worn parts on medical equipment
  • Keeping good records to maintain a trail of responsibility for both purchases and repairs

While this might not prevent every possible problem, it can reduce the chances that counterfeit devices will end up in use. It can also help patients who are injured due to defective or counterfeit devices uncover who is truly liable for their damages.

Source: MIMS Today, "The medical industry’s newest problem – counterfeit medical devices," accessed May 11, 2018

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