8% of all medical devices in the market are fake and only 20% of countries around the world have regulations in place to combat their development and spread. They are a danger to both public health and patient safety.

Over the past decade government and privates bodies in the UK and America have had to recall surgical devices such as clip cartridges and surgical mesh. In Taiwan, 13,000 plates and screws were discovered to be fake, affecting 100 hospitals.

In 2012, the Medical and Healthcare products Regulatory Agency had to conduct raids in UK after it was found that unapproved clinical equipment was being sold online. One mother used it to check her son’s temperature and the reading came normal despite the fact that he was suffering from a high fever due to leukaemia.

However it is not just fake devices, some genuine devices are being fitted with defective components. This makes the device more susceptible to malfunction.

So what is the medical industry doing in order to detect, stop and remove counterfeits?

A whole industry is developing around protecting devices

One thing that the NHS in the UK is doing is attaching barcodes to medical supplies, equipment, nurses, doctors and patients.

Called Scan4Safety, the scheme aims to track a patient’s care at each stage and identify each person, product, drug or place within the NHS. It is hoped that this enable manufacturers to trace devices within hospitals, and prevent fakes being brought online and mixed into authorized distributions.

This move comes hot on the heels of the EU finalising its new Medical Device Regulations. As a part of these regulations, all medical devices will have to be fitted with Unique Device Identification (UDI). It will be able to identify all medical devices from distribution through to use and thereby reduce fraud.

Many private companies are also examining ways in which to tag devices to secure them. Clariant, a specialty chemical company and SICPA, a security company, have partnered up to create a scheme called Plastiward.

There is tremendous scope through collaboration

“The whole idea here is to help pharma and medical devices companies bring safe medicines to the market; and the key idea is really to bring protection as close as possible to the drug,” SICPA’s director of New Channels and partnerships Yann Ischi says.

The scheme embeds proprietary taggants - a chemical or physical marker added to materials to allow various forms of testing - directly into the polymers used to produce plastic for medical devices. They can be monitored in real-time using the deployment and monitoring equipment provided by SICPA.

The ability to monitor products in real-time is important, because current device and drug taggants are hindered by how long it takes to collect the data from the field and then have it sent to analysts to determine whether the device has been tampered with or not. This longer time lapse means counterfeit devices are more likely to reach patients and put them at risk.

There will be struggles ahead

Steve Duckworth, Clariant’s head of Global Healthcare Polymer Solutions notes that, “you have copies which are extremely difficult to detect. Often even somebody who is skilled like a doctor cannot really tell the difference. So this is quite scary.”

“One of the things that’s quite clear with anti-counterfeit technology is that there is no magic bullet. I think most people who are the experts on this realise that you have to have a kind of layered approach,” Duckworth adds.

Tagging is likely to enable inventory efficiency in hospitals, link devices to patient files, reduce manual errors, free up nurse’s time and improve trust in manufacturer brands.

Additionally, implementing security to protect devices is a huge upfront cost that could put tremendous pressure on already stretched health services like the UK’s NHS.

This is likely to be outweighed however, by the long list of benefits. Protecting patient’s lives is the just the start. MIMS

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